86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details
臨床試験数 : 1,205 / 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05660863 (ClinicalTrials.gov) | June 1, 2023 | 1/12/2022 | A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of MN-08 Tablets | A Bridged Phase 1, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Dose of MN-08 in Healthy Subjects | Pulmonary Arterial Hypertension | Drug: MN-08 24 mg/day;Drug: MN-08 60 mg/day | Guangzhou Magpie Pharmaceuticals Co., Ltd. | NULL | Not yet recruiting | 18 Years | 45 Years | All | 16 | Phase 1 | NULL |
| 2 | NCT05731492 (ClinicalTrials.gov) | March 28, 2023 | 9/2/2023 | A Study of Macitentan in Children Below 2 Years of Age | A Multicenter, Open-label, Single-arm Study to Assess the Pharmacokinetics and Safety of Macitentan in Children Aged 1 Month to <2 Years With Pulmonary Arterial Hypertension | Arterial Hypertension, Pulmonary | Drug: Macitentan | Actelion | NULL | Recruiting | 1 Month | 2 Years | All | 10 | Phase 1 | Germany;Poland |
| 3 | NCT05764265 (ClinicalTrials.gov) | March 27, 2023 | 10/1/2023 | Extension Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension Participants | An Open-label Extension Study to Investigate Efficacy, Safety and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: LTP001 | Novartis Pharmaceuticals | NULL | Not yet recruiting | 18 Years | 75 Years | All | 40 | Phase 2 | NULL |
| 4 | NCT05649748 (ClinicalTrials.gov) | February 28, 2023 | 6/12/2022 | A Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH) | An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Treprostinil Palmitil;Drug: Placebo | Insmed Incorporated | NULL | Recruiting | 18 Years | N/A | All | 100 | Phase 2/Phase 3 | Japan |
| 5 | NCT04778046 (ClinicalTrials.gov) | February 15, 2023 | 26/2/2021 | Pulmonary Hypertension SOLAR | Defining a Noninvasive Signature for Pulmonary Vascular Remodeling in Group 3 PH | Interstitial Lung Disease;COPD;Pulmonary Arterial Hypertension | Drug: Hyperpolarized 129Xe | Bastiaan Driehuys | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 6 | NCT05564637 (ClinicalTrials.gov) | February 2023 | 28/9/2022 | A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension | Comprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in Interstitial Lung Disease Pulmonary Hypertension | Pulmonary Arterial Hypertension;Interstitial Lung Disease;Healthy Adults | Drug: Treprostinil;Diagnostic Test: Right Heart Catheterization (RHC) while exercising;Diagnostic Test: Optional Muscle Biopsy | Mayo Clinic | United Therapeutics | Recruiting | 18 Years | N/A | All | 18 | Phase 2 | United States |
| 7 | NCT05452889 (ClinicalTrials.gov) | January 31, 2023 | 9/6/2022 | PET Image in PAH Patients | Utilizing 18F-fluoroglutamine PET Imaging in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Diagnostic Test: 18F-FGLN PET Imaging;Drug: (18F)FPGLU | Stephen Y. Chan | Bayer;National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 18 Years | 75 Years | All | 50 | Early Phase 1 | United States |
| 8 | NCT05587712 (ClinicalTrials.gov) | January 19, 2023 | 17/10/2022 | Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008) | A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care | Pulmonary Arterial Hypertension | Drug: Sotatercept | Merck Sharp & Dohme LLC | NULL | Recruiting | 1 Year | 17 Years | All | 42 | Phase 2 | United States |
| 9 | NCT05179356 (ClinicalTrials.gov) | January 1, 2023 | 16/12/2021 | Dapagliflozin in Pulmonary Arterial Hypertension | Effects of DAPAgliflozin on Cardiopulmonary Exercise Capacity and Hemodynamics in Pulmonary Arterial Hypertension: A Double Blind Randomized Trial. (DAPAH-trial) | Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary Hypertension | Drug: Dapagliflozin 10 MG [Farxiga];Drug: Placebo | Mads Ersbøll | NULL | Not yet recruiting | 18 Years | N/A | All | 52 | Phase 2 | NULL |
| 10 | EUCTR2022-000478-25-ES (EUCTR) | 23/12/2022 | 13/10/2022 | Sotatercept in Children with Pulmonary Artery Hypertension on Standard of Care | A Phase 2 Open-label Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard of Care - Sotatercept in Children with PAH on SoC | Pulmonary arterial hypertension MedDRA version: 21.1;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Sotatercept Product Code: MK-7962 INN or Proposed INN: Sotatercept | Merck Sharp & Dohme LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2 | United States;Spain;Turkey;Israel;Colombia;United Kingdom;France;Mexico;Poland;Australia;South Africa;Netherlands;Germany | ||
| 11 | EUCTR2019-004131-24-PT (EUCTR) | 16/12/2022 | 25/08/2022 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Russian Federation;Singapore;United States;Czechia;Thailand;Portugal;Saudi Arabia;Austria;China;Korea, Republic of;Poland;Slovakia;France;Lithuania;Bulgaria;Serbia;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Spain;Canada;Turkey;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany | ||
| 12 | EUCTR2021-001910-13-NL (EUCTR) | 08/12/2022 | 16/02/2022 | Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH. | IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH). - IMPAHCT | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077730;Term: Pulmonary arterial hypertension WHO functional class IV;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available | Aerovate Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 462 | Phase 2;Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Colombia;Italy;France;Australia;South Africa;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Sweden | ||
| 13 | NCT05167825 (ClinicalTrials.gov) | November 14, 2022 | 24/11/2021 | A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension | A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (>=3 Months to <15 Years) With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Macitentan | Janssen Pharmaceutical K.K. | NULL | Recruiting | 3 Months | 15 Years | All | 6 | Phase 3 | Japan |
| 14 | NCT05557942 (ClinicalTrials.gov) | November 2, 2022 | 15/9/2022 | Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL) | A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002 (IMPAHCT-FUL) | Pulmonary Arterial Hypertension | Drug: AV-101 | Aerovate Therapeutics | NULL | Recruiting | 18 Years | 75 Years | All | 462 | Phase 3 | United States;Australia |
| 15 | NCT05339087 (ClinicalTrials.gov) | October 24, 2022 | 14/4/2022 | Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH | Efficacy and Safety of Riociguat (MK-4836) in Incipient Pulmonary Vascular Disease as an Indicator for Early Pulmonary Arterial Hypertension Double-blind, Randomized, Multicenter, Multinational, Placebo-controlled Phase IIa Study (ESRA) | Pulmonary Vascular Disorder;Primary Pulmonary Hypertension;Systemic Sclerosis;Other Systemic Involvement of Connective Tissue | Drug: Riociguat Oral Tablet;Other: Placebo | Heidelberg University | Merck Sharp & Dohme LLC | Recruiting | 18 Years | N/A | All | 70 | Phase 2 | Germany |
| 16 | NCT04915300 (ClinicalTrials.gov) | October 2022 | 19/5/2021 | Apabetalone for Pulmonary Arterial Hypertension | Apabetalone for Pulmonary Arterial Hypertension: a Phase 2 Clinical Study | Pulmonary Arterial Hypertension | Drug: Apabetalone;Drug: Placebo | Laval University | Canadian Institutes of Health Research (CIHR);Resverlogix Corp | Not yet recruiting | 18 Years | 75 Years | All | 72 | Phase 2 | Canada |
| 17 | JPRN-jRCT2011210057 | 30/09/2022 | 18/12/2021 | A Study of Macitentan in Japanese Pediatric Participants with Pulmonary Arterial Hypertension | A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (>=3 months to <15 years) with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Macitentan will be administered orally as a tablet. Participants will receive oral dose of macitentan based on age and weight through Week 52. | Nakano Masayoshi | NULL | Recruiting | >= 3month old | < 15age old | Both | 6 | Phase 3 | Japan |
| 18 | NCT04972656 (ClinicalTrials.gov) | September 5, 2022 | 9/7/2021 | Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension | Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension: a Multicenter, Randomized, Double-blind, Placebo-controlled Study | Pulmonary Arterial Hypertension | Drug: Ambrisentan;Drug: Placebo | Nanjing First Hospital, Nanjing Medical University | Tianjin Medical University General Hospital | Recruiting | 18 Years | N/A | All | 420 | N/A | China |
| 19 | NCT05339386 (ClinicalTrials.gov) | August 29, 2022 | 13/4/2022 | Developing Hyperpolarized 129Xe MRI Biomarkers for Evaluation of Pulmonary Arterial Hypertension | Developing Hyperpolarized 129Xe MRI Biomarkers for Evaluation of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Hyperpolarized Xe129 | University of Kansas Medical Center | American Heart Association | Recruiting | 18 Years | N/A | All | 22 | United States | |
| 20 | NCT05147805 (ClinicalTrials.gov) | August 24, 2022 | 24/11/2021 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension | A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Treprostinil Palmitil;Drug: Placebo | Insmed Incorporated | NULL | Recruiting | 18 Years | 75 Years | All | 99 | Phase 2 | United States;Argentina;Australia;Austria;Belgium;Brazil;Denmark;Germany;Italy;Japan;Malaysia;Mexico;Philippines;Serbia;Spain;Switzerland;United Kingdom |
| 21 | NCT05203510 (ClinicalTrials.gov) | August 10, 2022 | 10/1/2022 | A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension | A Phase 4, Prospective, Multicenter, Single-Arm Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Patients With Pulmonary Arterial Hypertension: ARTISAN (Afterload Reduction To Improve Right Ventricular Structure And FuNction) | Pulmonary Arterial Hypertension | Drug: Parenteral Treprostinil;Drug: Oral Treprostinil | United Therapeutics | Lung Biotechnology PBC | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | United States |
| 22 | JPRN-jRCT2071220033 | 02/08/2022 | 02/08/2022 | A Randomized, Double-Blind, Placebo-Controlled Study of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension | A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Experimental: Treprostinil Palmitil Inhalational Powder Participants will be administered TPIP once per day at a starting dose of 80 micrograms. Participants will be titrated to the highest tolerated dose for each individual participant of between 80 micrograms and 640 micrograms during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks. Placebo Comparator: Placebo Participants will be administered a placebo matching TPIP once per day for 16 weeks. | F Ismat | NULL | Recruiting | > 18age old | < 75age old | Both | 99 | Phase 2 | United States;Argentina;Australia;Mexico;Phillipines;Japan |
| 23 | NCT04039464 (ClinicalTrials.gov) | August 1, 2022 | 1/7/2019 | Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension | Kids MoD PAH Trial: Mono- vs. Duo-Therapy for Pediatric Pulmonary Arterial Hypertension | Pediatric Pulmonary Hypertension | Drug: Mono-Therapy with Sildenafil;Drug: Duo-Therapy with Sildenafil + Bosentan | Johns Hopkins University | NULL | Recruiting | 4 Months | 18 Years | All | 100 | Phase 3 | United States;Canada |
| 24 | NCT05587400 (ClinicalTrials.gov) | July 27, 2022 | 23/9/2022 | Consistency of Electrical Cardiometry and Pulmonary Artery Catheter | The Consistency of Cardiac Output Measured by Electrical Cardiometry and Pulmonary Artery Catheter in Cardiac Surgery Patients With Pulmonary Arterial Hypertension or Right Heart Dysfunction | Pulmonary Arterial Hypertension;Right Ventricular Dysfunction | Behavioral: passive leg raising;Drug: dobutamine test;Drug: inhaled nitric oxide | Shanghai Zhongshan Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 199 | N/A | China |
| 25 | NCT05679570 (ClinicalTrials.gov) | July 12, 2022 | 4/12/2022 | Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial) | Satralizumab,an Anti-IL-6 Receptor Antibody, in the Treatment of Pulmonary Arterial Hypertension; Safety and Efficacy Evaluation in Japan -Multicenter, Investigator-sponsored Trial- | Pulmonary Arterial Hypertension | Drug: Satralizumab (Genetical Recombination) | International University of Health and Welfare | Japan Agency for Medical Research and Development;Keio University | Recruiting | 20 Years | 79 Years | All | 24 | Phase 2 | Japan |
| 26 | EUCTR2021-006787-25-DK (EUCTR) | 06/07/2022 | 22/12/2021 | The effects of dapagliflozin in patients with elevated blood pressure in the lungs | Effects of DAPAgliflozin on cardiopulmonary exercise capacity and hemodynamics in Pulmonary Arterial Hypertension: A double blind randomized trial | Pulmonary arterial hypertensionChronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 24.1;Classification code 10085244;Term: Heritable pulmonary arterial hypertension;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.0;Classification code 10068740;Term: CTEPH;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Forxiga (dapagliflozin) Product Name: Forxiga INN or Proposed INN: Dapagliflozin | Rigshospitalet The Heart Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 2 | Denmark | ||
| 27 | NCT05135000 (ClinicalTrials.gov) | June 30, 2022 | 16/11/2021 | Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension | A Randomized, Participant- and Investigator-blinded, Placebo-controlled Study to Investigate Efficacy, Safety, and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: LTP001;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 44 | Phase 2 | Argentina;Germany;Netherlands;Poland;Spain;United Kingdom |
| 28 | NCT05427162 (ClinicalTrials.gov) | June 21, 2022 | 16/6/2022 | A Study of Single and Multiple Doses of Different Formulations of a Prostacyclin Receptor Agonist | Open-Label, Randomized Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Different Formulations of an IP Receptor Agonist | Pulmonary Arterial Hypertension | Drug: Prostacyclin Receptor Agonist | Actelion | NULL | Recruiting | 18 Years | 55 Years | All | 86 | Phase 1 | United States |
| 29 | JPRN-jRCT2051220042 | 07/06/2022 | 09/06/2022 | Clinical trial of Nitric Oxide inhalation therapy in patients with severe PH | A Single-Center, Randomised, Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide therapy in the patients with severe right heart failure due to pulmonary hypertension | Pulmonary arterial hypertension (PAH), and Chronic thromboembolic pulmonary hypertension (CTEPH) PH, Nitric oxide, PAH, CTEPH, Right heart failure;D006976 | Study drug: Nitric Oxide (INOflo for inhalation 800ppm) Start inhalation at a concentration of 20 ppm, and if the blood methemoglobin concentration is below 2%, increase the dose by 10 ppm every 5 minutes to a maximum concentration of 40 ppm. On withdrawal from inhalation, if hemodynamics and oxygenation are stable, reduce inhalation dose by half every 5 minutes, gradually decreasing to 5 ppm. And then, If hemodynamics and oxygenation are stable at 1 ppm, attempt inhalation withdrawal every 5 minutes. | Ogo Takeshi | NULL | Pending | >= 18age old | Not applicable | Both | 30 | Phase 2 | Japan |
| 30 | NCT05611268 (ClinicalTrials.gov) | June 3, 2022 | 24/8/2022 | Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome | Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome: a Randomized Study | Eisenmenger Syndrome | Drug: Pentoxifylline | University of Sao Paulo General Hospital | InCor Heart Institute | Recruiting | 10 Years | 80 Years | All | 48 | N/A | Brazil |
| 31 | NCT05224531 (ClinicalTrials.gov) | May 5, 2022 | 17/1/2022 | Effect of CS1 in Subjects With Pulmonary Arterial Hypertension | A Phase 2, Prospective, Randomized, Open-label, Blinded Endpoint, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of 3 Doses of CS1 in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: CS1 Administration | Cereno Scientific AB | Worldwide Clinical Trials | Recruiting | 18 Years | 80 Years | All | 30 | Phase 2 | Sweden |
| 32 | EUCTR2020-005061-13-AT (EUCTR) | 05/05/2022 | 02/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011/ MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011/ MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 33 | EUCTR2021-001910-13-ES (EUCTR) | 28/04/2022 | 25/01/2022 | Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH. | IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH). - IMPAHCT | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077730;Term: Pulmonary arterial hypertension WHO functional class IV;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available | Aerovate Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 462 | Phase 2;Phase 3 | United States;Portugal;Greece;Spain;Chile;Israel;Colombia;Italy;France;Australia;South Africa;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Sweden | ||
| 34 | EUCTR2021-000670-28-DE (EUCTR) | 19/04/2022 | 15/11/2021 | Study of efficacy and safety of LTP001 in pulmonary arterial hypertension participants | A randomized, participant- and investigator-blinded, placebo-controlled study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: LTP001 Product Code: LTP001 INN or Proposed INN: not available Other descriptive name: LTP001 Product Name: LTP001 Product Code: LTP001 INN or Proposed INN: not available Other descriptive name: LTP001 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | United States;Argentina;Spain;Poland;Russian Federation;Netherlands;Germany;United Kingdom | ||
| 35 | EUCTR2020-005061-13-HR (EUCTR) | 14/04/2022 | 12/05/2022 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 36 | NCT04954742 (ClinicalTrials.gov) | April 13, 2022 | 29/6/2021 | Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPH | An Open-label, Prospective, Single Centre Study of the Effects of Riociguat on RIght VEntricular Size and Function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension | Primary Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary Hypertension | Drug: Riociguat | Heidelberg University | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | Germany |
| 37 | NCT05208814 (ClinicalTrials.gov) | March 31, 2022 | 29/12/2021 | a Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients With Renal Insufficiency and Healthy Subjects | a Parallel, Open, Single-dose Administration Phase I Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients With Renal Insufficiency and Healthy Subjects | Pulmonary Arterial Hypertension;Erectile Dysfunction | Drug: TPN171H single dose | Vigonvita Life Sciences | Shanghai Institute of Materia Medica, Chinese Academy of Sciences | Completed | 18 Years | 70 Years | All | 16 | Phase 1 | China |
| 38 | NCT04791514 (ClinicalTrials.gov) | March 29, 2022 | 8/3/2021 | A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH) | An Open-Label Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Treprostinil Palmitil | Insmed Incorporated | NULL | Terminated | 18 Years | N/A | All | 1 | Phase 2 | United States |
| 39 | EUCTR2020-005061-13-DK (EUCTR) | 25/03/2022 | 22/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 40 | NCT04811092 (ClinicalTrials.gov) | March 18, 2022 | 16/3/2021 | Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension | Drug: Sotatercept;Other: Placebo | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Recruiting | 18 Years | N/A | All | 662 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom |
| 41 | EUCTR2020-005061-13-PT (EUCTR) | 18/03/2022 | 07/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Germany;New Zealand;Sweden;United States;Serbia;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia | ||
| 42 | EUCTR2021-001633-40-DE (EUCTR) | 07/03/2022 | 06/12/2021 | Clinical trial investigating the effect of riociguat among patients with slightly elevated blood pressure in lung vessels | Efficacy and safety of riociguat (MK-4836) in incipient pulmonary vascular disease as an indicator for early pulmonary arterial Hypertension Doubleblind, randomized, multicentre, multinational, placebo-controlled phase IIastudyESRA - ESRA | early pulmonary vascular disease, defined as either a) mean pulmonary arterial pressure (mPAP) =25 mmHg with pulmonary vascular resistance (PVR) =2 to <3 WU and pulmonary arterial wedge pressure (PAWP) =15 mmHg or b) mPAP 21-<25 mmHg with PVR =2 WU, and PAWP =15 mmHg associated with connective tissue disease (CTD) or as idiopathic/heritable form. MedDRA version: 20.0;Level: HLT;Classification code 10037455;Term: Pulmonary vascular disorders NEC;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 | Thoraxklinik Heidelberg gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | France;Austria;Norway;Germany;United Kingdom;Switzerland;Italy | ||
| 43 | EUCTR2020-005061-13-BE (EUCTR) | 07/03/2022 | 26/11/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 / MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 / MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden;Spain | ||
| 44 | EUCTR2020-005061-13-CZ (EUCTR) | 02/03/2022 | 20/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 / MK - 7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 / MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 45 | EUCTR2021-001910-13-FR (EUCTR) | 21/02/2022 | 23/12/2021 | Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH. | IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH). - IMPAHCT | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077730;Term: Pulmonary arterial hypertension WHO functional class IV;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available | Aerovate Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 462 | Phase 2;Phase 3 | United States;Portugal;Greece;Spain;Chile;Israel;Colombia;Italy;France;Australia;South Africa;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Sweden | ||
| 46 | JPRN-jRCT2031210626 | 15/02/2022 | 23/02/2022 | SATISFY-JP Trial | Satralizumab, an Anti-IL-6 receptor antibody, in the treatment of pulmonary arterial hypertension; safety and efficacy evaluation in Japan - Multicenter, Investigator-sponsored Trial- - SATISFY-JP Trial | Pulmonary Arterial Hypertension;D006976 | The trial will consist of three periods: a screening period (within 30 days), an efficacy evaluation period (24 weeks), and a continuous administration period (28 weeks). Screening period Written consent will be obtained from patients with PAH who have immune responsive-phenotype and inadequate response to existing drugs. After obtaining consent, screening tests related to the study will be conducted to determine eligibility for the study. Baseline testing will be conducted between enrollment and the start of study drug administration. Efficacy Evaluation Period The study drug will be administered at a dose of 120 mg subcutaneously at initial, 2-week, 4-week, and 4-week intervals thereafter. Efficacy will be assessed after 24 weeks of study drug administration. Subjects who demonstrate efficacy and wish to continue treatment will receive the study drug for 24 weeks and moving to the continuous treatment period. In all other cases, the study will be terminated after 24 weeks of the efficacy evaluation period without the administration of study drug. Continuation Dosing Period Subjects who demonstrate efficacy during the efficacy evaluation period and wish to continue will receive continued treatment with satralizumab at a dose of 120 mg subcutaneously every 4 weeks. | Tamura Yuichi | NULL | Recruiting | >= 20age old | < 80age old | Both | 24 | Phase 2 | Japan |
| 47 | EUCTR2020-005061-13-NL (EUCTR) | 09/02/2022 | 25/11/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 48 | EUCTR2021-001498-21-DE (EUCTR) | 01/02/2022 | 24/09/2021 | A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 3 | France;United States;Mexico;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 49 | EUCTR2021-000199-12-IT (EUCTR) | 26/01/2022 | 09/09/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- andHigh-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: [ACE-011] INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | ACCELERON PHARMA INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | Serbia;United States;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Chile;Colombia;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 50 | EUCTR2021-001498-21-IT (EUCTR) | 26/01/2022 | 10/09/2021 | A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: [ACE-011] | ACCELERON PHARMA INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 3 | France;United States;Mexico;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 51 | EUCTR2020-005061-13-PL (EUCTR) | 26/01/2022 | 02/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011/ MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 / MK-7962 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United States;Czechia;Portugal;Greece;Austria;Sweden;Netherlands;Poland;Brazil;Korea, Republic of;France;Serbia;Croatia;Colombia;Argentina;United Kingdom;Switzerland;Spain;New Zealand;Canada;Czech Republic;Belgium;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany | ||
| 52 | EUCTR2021-000199-12-HR (EUCTR) | 19/01/2022 | 03/02/2022 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | United States;Portugal;Serbia;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 53 | EUCTR2020-005061-13-SE (EUCTR) | 10/01/2022 | 12/10/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Brazil;Belgium;Poland;Croatia;United States;Portugal;Serbia;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Germany;New Zealand;Sweden | ||
| 54 | EUCTR2021-003020-32-ES (EUCTR) | 03/01/2022 | 19/10/2021 | A Phase 2 Study of Sotatercept for Combined Postcapillary and Precapillary Pulmonary Hypertension Treatment | Phase 2, Double-blind, Randomized, Placebocontrolled Study to Evaluate the Effects of Sotatercept versus Placebo-Controlled for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF) - A Phase 2 Study of Sotatercept for Cpc-PH Treatment | Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved EjectionFraction (HFpEF) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: SOTATERCEPT | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | France;United States;Canada;Belgium;Spain;Israel;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 55 | EUCTR2020-004971-42-AT (EUCTR) | 21/12/2021 | 07/09/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Bulgaria;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 56 | NCT05185011 (ClinicalTrials.gov) | December 16, 2021 | 22/12/2021 | Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild ,Moderate Hepatic Insufficiency and Normal Liver Function | A Phase I Clinical Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild Liver Insufficiency, Moderate Liver Insufficiency and Normal Liver Function | Erectile Dysfunction;Pulmonary Arterial Hypertension | Drug: TPN171H | Vigonvita Life Sciences | Shanghai Institute of Materia Medica, Chinese Academy of Sciences | Completed | 18 Years | 65 Years | All | 24 | Phase 1 | China |
| 57 | EUCTR2021-000199-12-DK (EUCTR) | 16/12/2021 | 23/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 58 | NCT05036135 (ClinicalTrials.gov) | December 2, 2021 | 16/8/2021 | A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH) | IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: AV-101;Drug: Placebo | Aerovate Therapeutics | NULL | Recruiting | 18 Years | 75 Years | All | 462 | Phase 2/Phase 3 | United States;Argentina;Australia;Belgium;Canada;Chile;France;Israel;Italy;Poland;Puerto Rico;Singapore;South Africa;Spain;Sweden;United Kingdom |
| 59 | NCT04896008 (ClinicalTrials.gov) | December 1, 2021 | 13/5/2021 | A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk Mortality | Pulmonary Arterial Hypertension | Drug: Sotatercept;Other: Placebo | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Spain;United Kingdom |
| 60 | EUCTR2021-000199-12-CZ (EUCTR) | 29/11/2021 | 10/09/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Italy;Switzerland;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 61 | EUCTR2021-004002-21-AT (EUCTR) | 26/11/2021 | 06/09/2021 | A non-randomized, single-center, open, two-period study with paired design to compare measured steady-state treprostinil concentrations in human plasma under treatment with a 10 mg/ml treprostinil formulation and following a switch to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH) | A single center, open-label, two-period, non-randomized, paired-design study to compare steady-state plasma levels following switch from a 10 mg/ml treprostinil formulation to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH) | pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: 20 mg/ml Treprostinil INN or Proposed INN: treprostinil sodium Other descriptive name: TREPROSTINIL SODIUM Trade Name: Trisuva(r) Product Name: Trisuva(r) INN or Proposed INN: treprostinil sodium Other descriptive name: TREPROSTINIL SODIUM | AOP Orphan Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Austria | ||
| 62 | EUCTR2021-001498-21-NL (EUCTR) | 15/11/2021 | 14/09/2021 | A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 3 | France;United States;Mexico;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;Italy | ||
| 63 | EUCTR2021-000199-12-AT (EUCTR) | 12/11/2021 | 26/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Spain;Ireland;Israel;Chile;Colombia;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden | ||
| 64 | EUCTR2021-001498-21-ES (EUCTR) | 11/11/2021 | 31/08/2021 | A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 3 | France;United States;Mexico;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 65 | EUCTR2019-002533-11-BG (EUCTR) | 08/11/2021 | 02/09/2021 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 66 | NCT04884971 (ClinicalTrials.gov) | November 3, 2021 | 7/5/2021 | Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study | Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study | Pulmonary Arterial Hypertension | Drug: Intestinal microbiota transplant (IMT) | University of Minnesota | NULL | Recruiting | 18 Years | 75 Years | All | 12 | Phase 1 | United States |
| 67 | EUCTR2021-000199-12-ES (EUCTR) | 27/10/2021 | 23/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Chile;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 68 | EUCTR2020-004971-42-DE (EUCTR) | 26/10/2021 | 19/04/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | United States;Czechia;Ukraine;United Kingdom;Spain;Canada;Austria;Latvia;Czech Republic;Belgium;Moldova, Republic of;Poland;Italy;France;Bulgaria;Serbia;Bosnia and Herzegovina;Germany | ||
| 69 | EUCTR2021-000199-12-NL (EUCTR) | 20/10/2021 | 30/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 70 | EUCTR2021-000199-12-DE (EUCTR) | 19/10/2021 | 19/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden;Austria;United Kingdom;Czech Republic;Canada;Serbia;United States;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia | ||
| 71 | EUCTR2020-004971-42-BG (EUCTR) | 12/10/2021 | 05/07/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Bulgaria;Latvia;Germany;Moldova, Republic of;Bosnia and Herzegovina | ||
| 72 | EUCTR2021-000199-12-SE (EUCTR) | 04/10/2021 | 05/08/2021 | A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 662 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 73 | EUCTR2020-001108-40-GR (EUCTR) | 04/10/2021 | 13/07/2021 | Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension - Phase 2/3 Study of MK-5475 in Adults with Pulmonary Arterial Hypertension | Pulmonary arterial hypertension MedDRA version: 20.0;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: MK-5475 Product Code: MK-5475 INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 Product Name: MK-5475 Product Code: MK-5475 INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 Product Name: MK-5475 Product Code: MK-5475 INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 | Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2;Phase 3 | United States;Greece;Turkey;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Australia;Germany;New Zealand;Sweden | ||
| 74 | NCT04908397 (ClinicalTrials.gov) | September 29, 2021 | 17/5/2021 | Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension | Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Familial Primary Pulmonary Hypertension;Primary Pulmonary Hypertension;Lung Diseases;Carnitine Nutritional Deficiency | Dietary Supplement: L-carnitine | Vanderbilt University Medical Center | NULL | Recruiting | 18 Years | 85 Years | All | 12 | Phase 1 | United States |
| 75 | NCT04991454 (ClinicalTrials.gov) | September 1, 2021 | 7/7/2021 | Xenon MRI Pulm Hypertension | Xenon MRI in Pulmonary Hypertension | Pulmonary Hypertension;Pulmonary Arterial Hypertension | Drug: 129Xe Hyperpolarized | Bastiaan Driehuys | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Phase 2 | United States |
| 76 | NCT05039086 (ClinicalTrials.gov) | September 1, 2021 | 1/9/2021 | Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5 Inhibitors vs Endothelin Receptor Antagonist | Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- PDE5 Inhibitors vs Endothelin Receptor Antagonist | Pulmonary Arterial Hypertension | Drug: PDE5 inhibitor;Drug: Endothelin Receptor Antagonists | Brigham and Women's Hospital | National Institute on Aging (NIA);Rutgers University;Johns Hopkins University | Active, not recruiting | 65 Years | N/A | All | 12947 | United States | |
| 77 | EUCTR2020-004971-42-PL (EUCTR) | 20/08/2021 | 25/05/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Bulgaria;Latvia;Germany;Moldova, Republic of;Bosnia and Herzegovina | ||
| 78 | EUCTR2020-004815-29-DE (EUCTR) | 04/08/2021 | 10/03/2021 | A phase 2 study to investigate the effects on the blood flow induced by step-wise increased doses of intravenously administered ularitide in patients suffering from pulmonary arterial hypertension | Open-label, dose escalation study of ularitide for the investigation of hemodynamic effects in patients with pulmonary arterial hypertension (UPAH) | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ularitide INN or Proposed INN: ULARITIDE Other descriptive name: Urodilatin | Cardiorentis AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | Germany | ||
| 79 | EUCTR2020-004971-42-CZ (EUCTR) | 22/07/2021 | 06/05/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Bulgaria;Latvia;Germany;Moldova, Republic of;Bosnia and Herzegovina | ||
| 80 | EUCTR2020-004971-42-ES (EUCTR) | 22/07/2021 | 22/07/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Bulgaria;Germany;Latvia;Bosnia and Herzegovina | ||
| 81 | NCT04813926 (ClinicalTrials.gov) | July 16, 2021 | 22/3/2021 | A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patients in the United States Who Are Receiving Riociguat for High Blood Pressure in the Arteries That Carry Blood From the Heart to the Lungs (Pulmonary Arterial Hypertension, PAH) | RiOciguAt UseRs Registry | Pulmonary Arterial Hypertension | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | Xcenda, LLC | Recruiting | 18 Years | N/A | All | 500 | United States;Puerto Rico | |
| 82 | EUCTR2020-004971-42-BE (EUCTR) | 12/07/2021 | 28/04/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Bulgaria;Germany;Latvia;Bosnia and Herzegovina | ||
| 83 | EUCTR2020-004971-42-LV (EUCTR) | 09/07/2021 | 22/04/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: RVT-1201 INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | United States;Serbia;Czechia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Bulgaria;Latvia;Germany;Bosnia and Herzegovina | ||
| 84 | NCT04435782 (ClinicalTrials.gov) | July 7, 2021 | 15/6/2020 | A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging | A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging | Pulmonary Arterial Hypertension | Drug: JNJ-67896049 | Actelion | NULL | Recruiting | 18 Years | 64 Years | All | 80 | Phase 4 | United States;Argentina;Brazil;China;France;Germany;Hong Kong;Israel;Italy;Korea, Republic of;Malaysia;Netherlands;Russian Federation;Saudi Arabia;Singapore;United Arab Emirates;United Kingdom |
| 85 | EUCTR2020-005061-13-ES (EUCTR) | 06/07/2021 | 08/07/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 86 | EUCTR2020-004971-42-IT (EUCTR) | 05/07/2021 | 07/06/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension - ELEVATE 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Rodatristat ethyl Product Code: [RVT-1201] INN or Proposed INN: Rodatristat ethyl Other descriptive name: Rodatristat ethyl | Altavant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Serbia;United States;Czechia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Bulgaria;Germany;Latvia;Bosnia and Herzegovina | ||
| 87 | EUCTR2020-005169-15-ES (EUCTR) | 28/06/2021 | 05/07/2021 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2- YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Serbia;Czechia;Canada;Belgium;Spain;Austria;Australia;Israel;Germany;United Kingdom | ||
| 88 | EUCTR2020-004142-11-PL (EUCTR) | 24/06/2021 | 23/03/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 284 | Phase 3 | United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 89 | EUCTR2020-004142-11-IT (EUCTR) | 23/06/2021 | 08/06/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - - | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: [ACE-011] | ACCELERON PHARMA INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 284 | Phase 3 | Serbia;United States;Czechia;Spain;Korea, Democratic People's Republic of;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 90 | EUCTR2020-005462-34-DE (EUCTR) | 23/06/2021 | 25/02/2021 | Study to investigate the effect of riociguat on right heart size and function in pulmonary hypertension | An open-label, prospective, single centre study of the effects of Riociguat on RIght VEntricular size and function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension - RIVER II | Symptomatic pulmonary arterial hypertension with a mean pulmonary artery pressure >20 mmHg and pulmonary vascular resistance =2 Wood Units, pulmonary arterial wedge pressure =15 mmHg (Group I / Nice Clinical Classification of Pulmonary Hypertension (PH)) or CTEPH (Group IV) with hemodynamics as stated above defined as inoperable measured at least 3 months after start of full anticoagulation or with persisting or recurrent PH after pulmonary endarterectomy at least 6 months after surgery MedDRA version: 20.0;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 | Thoraxklinik Heidelberg gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Germany | ||
| 91 | JPRN-jRCT2061200058 | 23/06/2021 | 19/02/2021 | Outcome Study Assessing a 75 milligrams (mg) Dose of Macitentan in Patients with Pulmonary Arterial Hypertension | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg - UNISUS | Pulmonary Arterial Hypertension | Macitentan 10 mg: Participants will receive macitentan 10 mg film-coated tablets orally. Macitentan 37.5 mg: Participants will receive macitentan 37.5 mg film-coated tablets orally. Macitentan 75 mg: Participants will receive macitentan 75 mg film-coated tablets orally. Placebo: Participants will receive matching placebo film-coated tablets orally. | Nakano Masayoshi | NULL | Recruiting | >= 18age old | Not applicable | Both | 900 | Phase 3 | Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Korea, Republic Of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Japan |
| 92 | EUCTR2017-003934-10-PL (EUCTR) | 23/06/2021 | 26/07/2019 | A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary hypertension and who were previously treated with macitentan in clinical studies. | mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA | Pulmonary arterial hypertension (PAH)Chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 3 | France;Belarus;Belgium;Poland;Ukraine;Turkey;Russian Federation;Germany | ||
| 93 | EUCTR2020-005061-13-DE (EUCTR) | 22/06/2021 | 24/02/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept - 60 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc Product Name: Sotatercept - 45 mg/vial Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United States;Portugal;Serbia;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 94 | EUCTR2020-005169-15-CZ (EUCTR) | 17/06/2021 | 07/04/2021 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2- YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany | ||
| 95 | EUCTR2020-005169-15-AT (EUCTR) | 16/06/2021 | 13/04/2021 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2- YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany | ||
| 96 | NCT04903730 (ClinicalTrials.gov) | May 24, 2021 | 24/5/2021 | Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution | A Randomised, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Inhaled Doses of Imatinib Inhalation Solution (AER-901) in Adult Healthy Volunteers | Pulmonary Arterial Hypertension | Drug: AER-901 Solution for Nebulization;Drug: Placebo | Aerami Therapeutics | NULL | Completed | 18 Years | 60 Years | All | 83 | Phase 1 | Australia |
| 97 | NCT04732221 (ClinicalTrials.gov) | May 19, 2021 | 27/1/2021 | A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007) | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Hypertension, Pulmonary | Drug: MK-5475;Drug: Placebo to MK-5475 | Merck Sharp & Dohme LLC | NULL | Recruiting | 18 Years | 75 Years | All | 450 | Phase 2/Phase 3 | United States;Argentina;Australia;Belgium;Canada;Colombia;France;Germany;Greece;Israel;Italy;Mexico;New Zealand;Poland;Russian Federation;Sweden;Turkey;United Kingdom |
| 98 | EUCTR2020-004142-11-DE (EUCTR) | 12/05/2021 | 19/01/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 3 | Argentina;United States;Czechia;United Kingdom;Switzerland;Spain;New Zealand;Canada;Austria;Sweden;Netherlands;Czech Republic;Belgium;Ireland;Brazil;Korea, Republic of;Poland;Mexico;Italy;Israel;Australia;France;Serbia;Germany | ||
| 99 | NCT04796337 (ClinicalTrials.gov) | May 12, 2021 | 22/2/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004) | An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH | Pulmonary Arterial Hypertension;PAH | Biological: Sotatercept | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Recruiting | 18 Years | N/A | All | 700 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom |
| 100 | EUCTR2019-002669-37-BE (EUCTR) | 04/05/2021 | 18/01/2021 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany | ||
| 101 | EUCTR2019-001598-10-AT (EUCTR) | 29/04/2021 | 23/01/2020 | Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension | A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension | Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera | PhaseBio Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 102 | EUCTR2020-001108-40-IT (EUCTR) | 21/04/2021 | 07/06/2021 | Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension - Phase 2/3 Study of MK-5475 in Adults with Pulmonary Arterial Hypertension | Pulmonary arterial hypertension MedDRA version: 20.0;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: MK-5475 Product Code: [MK-5475] INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 Product Name: MK-5475 Product Code: [MK-5475] INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 Product Name: MK-5475 Product Code: [MK-5475] INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 | MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2;Phase 3 | United States;Portugal;Turkey;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Germany;New Zealand;Sweden | ||
| 103 | EUCTR2020-001108-40-PL (EUCTR) | 19/04/2021 | 05/02/2021 | Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension - Phase 2/3 Study of MK-5475 in Adults with Pulmonary Arterial Hypertension | Pulmonary arterial hypertension MedDRA version: 20.0;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: MK-5475 Product Code: MK-5475 INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 Product Name: MK-5475 Product Code: MK-5475 INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 Product Name: MK-5475 Product Code: MK-5475 INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 | Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2;Phase 3 | United States;Portugal;Turkey;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Germany;New Zealand;Sweden | ||
| 104 | EUCTR2019-002817-21-FI (EUCTR) | 16/04/2021 | 11/02/2021 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden | ||
| 105 | EUCTR2020-004142-11-BE (EUCTR) | 15/04/2021 | 08/02/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 284 | Phase 3 | United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 106 | EUCTR2020-001108-40-DE (EUCTR) | 08/04/2021 | 19/01/2021 | Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension - Phase 2/3 Study of MK-5475 in Adults with Pulmonary Arterial Hypertension | Pulmonary arterial hypertension MedDRA version: 20.0;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: MK-5475 Product Code: MK-5475 INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 Product Name: MK-5475 Product Code: MK-5475 INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 Product Name: MK-5475 Product Code: MK-5475 INN or Proposed INN: MK-5475 Other descriptive name: MK-5475 | Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2;Phase 3 | United States;Portugal;Greece;Turkey;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Germany;New Zealand;Sweden | ||
| 107 | NCT05569655 (ClinicalTrials.gov) | April 6, 2021 | 1/10/2022 | Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH | Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With Right Heart Failure Caused by Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Randomized Controlled Trial | Drug: Tolvaptan;Drug: Furosemide | Chinese Pulmonary Vascular Disease Research Group | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | China |
| 108 | NCT04816604 (ClinicalTrials.gov) | April 5, 2021 | 23/3/2021 | Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH) | An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Device: Generic Dry Powder Inhaler;Drug: GB002 (seralutinib) | GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | NULL | Recruiting | 18 Years | 80 Years | All | 100 | Phase 2 | United States;Australia;Czechia;France;Germany;Spain;United Kingdom |
| 109 | EUCTR2020-004142-11-SE (EUCTR) | 26/03/2021 | 28/01/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 284 | Phase 3 | Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 110 | EUCTR2020-004142-11-NL (EUCTR) | 24/03/2021 | 17/02/2021 | A Phase 3 Study of Sotatercept for the Treatment of PAH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 284 | Phase 3 | United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 111 | NCT04712669 (ClinicalTrials.gov) | March 15, 2021 | 12/1/2021 | A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2) | A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: rodatristat ethyl 300 mg tablet BID;Drug: rodatristat ethyl 600 mg BID;Drug: Placebo | Altavant Sciences GmbH | NULL | Recruiting | 18 Years | N/A | All | 90 | Phase 2 | Austria;United States;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Czechia;France;Germany;Italy;Latvia;Moldova, Republic of;Poland;Serbia;Spain;Ukraine;United Kingdom |
| 112 | NCT04576988 (ClinicalTrials.gov) | January 25, 2021 | 28/9/2020 | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH | Pulmonary Arterial Hypertension | Biological: Sotatercept;Drug: Placebo;Drug: Background PAH Therapy | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Completed | 18 Years | N/A | All | 324 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;France;Germany;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Serbia;Spain;Sweden;Switzerland;United Kingdom |
| 113 | EUCTR2019-002669-37-CZ (EUCTR) | 21/01/2021 | 22/10/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Serbia;Czechia;Spain;United States | ||
| 114 | NCT04416750 (ClinicalTrials.gov) | January 20, 2021 | 28/5/2020 | Positioning Imatinib for Pulmonary Arterial Hypertension | Positioning Imatinib for Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Imatinib Mesylate | Imperial College London | National Institute for Health Research, United Kingdom;Medical Research Council;University of Cambridge;University of Sheffield | Recruiting | 18 Years | 80 Years | All | 43 | Phase 2 | United Kingdom |
| 115 | EUCTR2019-002669-37-DE (EUCTR) | 07/01/2021 | 28/07/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany | ||
| 116 | NCT04280523 (ClinicalTrials.gov) | January 5, 2021 | 15/1/2020 | TranspulmonarY Estrogen Gradient and Estrogen Receptors (TYEGER) in PAH | TranspulmonarY Estrogen Gradient and Estrogen Receptors (TYEGER) in PAH | Pulmonary Arterial Hypertension | Drug: ESR-specific PET scan | Vanderbilt University Medical Center | NULL | Recruiting | 13 Years | N/A | All | 40 | Phase 2 | United States |
| 117 | EUCTR2019-002669-37-AT (EUCTR) | 15/12/2020 | 07/08/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany | ||
| 118 | NCT04456998 (ClinicalTrials.gov) | December 14, 2020 | 30/6/2020 | GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Artery Hypertension | Drug: GB002 (seralutinib);Drug: Placebo;Device: Generic Dry Powder Inhaler | GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | NULL | Completed | 18 Years | 75 Years | All | 86 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Serbia;Spain;United Kingdom;Israel |
| 119 | EUCTR2019-004783-22-NL (EUCTR) | 03/12/2020 | 30/06/2020 | A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial Hypertension | A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 4 | United Arab Emirates;United States;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Malaysia;Singapore;Germany;Netherlands;China;Korea, Republic of | ||
| 120 | EUCTR2019-004131-24-GB (EUCTR) | 23/11/2020 | 26/05/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 121 | EUCTR2019-004783-22-DE (EUCTR) | 23/11/2020 | 17/07/2020 | A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial Hypertension | A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 4 | United Arab Emirates;United States;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Malaysia;Singapore;Netherlands;Germany;China;Korea, Republic of | ||
| 122 | JPRN-JapicCTI-205391 | 18/11/2020 | 30/07/2020 | An exploratory study of NS-304 | A phase 2 exploratory study of NS-304 in Japanese pediatric patients with pulmonary arterial hypertension | Pulmonary arterial hypertension | Intervention name : NS-304 INN of the intervention : Selexipag Dosage And administration of the intervention : Oral administration Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Nippon Shinyaku Co., Ltd. | NULL | complete | 2 | 14 | BOTH | 6 | Phase 2 | Japan |
| 123 | EUCTR2019-004783-22-GB (EUCTR) | 16/11/2020 | 26/08/2020 | A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial Hypertension | A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 4 | United States;United Arab Emirates;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Germany;Netherlands;China;Korea, Republic of | ||
| 124 | EUCTR2019-002533-11-AT (EUCTR) | 12/11/2020 | 04/09/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden | ||
| 125 | EUCTR2019-002533-11-SK (EUCTR) | 12/11/2020 | 13/08/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 126 | EUCTR2019-004131-24-LT (EUCTR) | 10/11/2020 | 22/09/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 127 | EUCTR2019-002533-11-NO (EUCTR) | 29/10/2020 | 03/08/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Norway;Germany;Japan;Sweden | ||
| 128 | NCT04084678 (ClinicalTrials.gov) | October 29, 2020 | 6/9/2019 | A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated Therapy | PAH;Pulmonary Hypertension;Hypertension;Connective Tissue Disease;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease;Pulmonary Arterial Hypertension | Drug: Ralinepag;Drug: Placebo | United Therapeutics | NULL | Active, not recruiting | 18 Years | N/A | All | 10 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Germany;Italy;Poland;Spain |
| 129 | JPRN-JapicCTI-194971 | 23/10/2020 | 25/09/2019 | Clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed-dose combination therapy in subjects with pulmonary arterial hypertension (PAH) | Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies with the Corresponding Fixed Dose Combination in Subjects with Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period with Macitentan and Tadalafil Fixed Dose Combination Therapy | pulmonary arterial hypertension | Intervention name : ACT-064992D INN of the intervention : - Dosage And administration of the intervention : Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments. Control intervention name : Macitentan INN of the control intervention : - Dosage And administration of the control intervention : Film-coated tablet with 10 mg macitentan, to be administered orally once daily. Control intervention name : Tadalafil INN of the control intervention : - Dosage And administration of the control intervention : Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : FDC therapy + Placebo macitentan + Placebo tadalafil , Macitentan mono-therapy + Placebo tadalafil + Placebo FDC, Tadalafil mono-therapy + Placebo macitentan + Placebo FDC | Janssen Pharmaceutical K.K. | NULL | complete | 18 | BOTH | 170 | Phase 3 | Japan, South America, Europe | |
| 130 | NCT04589390 (ClinicalTrials.gov) | October 15, 2020 | 8/10/2020 | Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension | Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension | Pulmonary Hypertension;Schistosomiasis | Drug: Selexipag | University of Sao Paulo General Hospital | Janssen-Cilag Ltd. | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | Brazil |
| 131 | EUCTR2019-002669-37-GB (EUCTR) | 08/10/2020 | 11/05/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Serbia;France;Austria;Australia;Israel;Germany;United Kingdom;Canada;Belgium;Singapore | ||
| 132 | NCT04567602 (ClinicalTrials.gov) | October 6, 2020 | 23/9/2020 | A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag | Non-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO) | Pulmonary Arterial Hypertension | Drug: PAH medication | Janssen-Cilag S.p.A. | NULL | Active, not recruiting | 18 Years | N/A | All | 186 | Italy | |
| 133 | EUCTR2019-002669-37-FR (EUCTR) | 01/10/2020 | 15/07/2020 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Serbia;France;Canada;Belgium;Singapore;Austria;Australia;Israel;Germany;United Kingdom | ||
| 134 | ChiCTR2000036852 | 2020-10-01 | 2020-08-25 | Establishment of an artificial intelligence screening and evaluation system based on multimodal imaging of pulmonary arterial hypertension: Study on clinical diagnosis model | Establishment of an artificial intelligence screening and evaluation system based on multimodal imaging of pulmonary arterial hypertension: Study on clinical diagnosis model | pulmonary arterial hypertension | Gold Standard:Right heart catheterization;Index test:multimodal imaging artificial intelligence screening and evaluation system; | Shanghai Pulmonary Hospital | NULL | Pending | Both | Target condition:1000;Difficult condition:1000 | NULL | |||
| 135 | EUCTR2019-002533-11-NL (EUCTR) | 29/09/2020 | 29/04/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 655 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Norway;Germany;Japan;Sweden | ||
| 136 | NCT04266197 (ClinicalTrials.gov) | September 25, 2020 | 22/1/2020 | Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study | A Phase 2b, Open-label, Single Dose Study to Evaluated the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing (CPET) in Subjects With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI) | Respira Therapeutics, Inc. | NULL | Recruiting | 18 Years | 80 Years | All | 86 | Phase 2 | United States;Serbia |
| 137 | EUCTR2020-002788-80-DE (EUCTR) | 09/09/2020 | 08/06/2020 | Study to evaluate the safety, tolerability and efficacy of AZD4831 in thetreatment of patients with pulmonary hypertension | An explorative study to assess the safety, tolerability, and efficacy of AZD4831 in the treatment of pulmonary arterial hypertension (PAH)(MPO-PAH) | Group 1: Pulmonary arterial hypertension (PAH)Group 2: Postcapillary pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AZD4831 | University of Cologne | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Germany | ||
| 138 | NCT04505137 (ClinicalTrials.gov) | September 2, 2020 | 31/7/2020 | A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers | A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of A Single Intravenous Dose Of GMA301 Injection In Healthy Volunteers | Pulmonary Arterial Hypertension | Drug: GMA301 Injection;Other: GMA301 Placebo Injection | Gmax Biopharm Australia Pty Ltd. | Metaclinical;Syneos Heath | Completed | 18 Years | 60 Years | All | 16 | Phase 1 | Australia |
| 139 | EUCTR2019-002533-11-PT (EUCTR) | 31/08/2020 | 11/05/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Belarus;Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Norway;Germany;Japan;Sweden | ||
| 140 | EUCTR2019-002817-21-LT (EUCTR) | 13/08/2020 | 25/05/2020 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Australia;China;Korea, Republic of;Finland;Turkey;Lithuania;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 141 | EUCTR2019-004131-24-DE (EUCTR) | 10/08/2020 | 26/05/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 142 | NCT04528056 (ClinicalTrials.gov) | August 1, 2020 | 14/8/2020 | Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension | Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Sulfasalazine;Drug: Ambrisentan;Drug: Sulfasalazine's placebo;Drug: Ambrisentan's placebo | RenJi Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 80 | Phase 1/Phase 2 | China |
| 143 | NCT03833323 (ClinicalTrials.gov) | August 1, 2020 | 5/2/2019 | Implantable System for Remodulin Post-Approval Study | Implantable System for Remodulin Post-Approval Study | Pulmonary Arterial Hypertension | Combination Product: Implantable System for Remodulin (treprostinil) | Medtronic Cardiac Rhythm and Heart Failure | United Therapeutics | Withdrawn | 22 Years | N/A | All | 0 | NULL | |
| 144 | EUCTR2019-003309-88-DE (EUCTR) | 30/07/2020 | 21/02/2020 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Argentina;Spain;Poland;Belgium;Brazil;Austria;Australia;Germany;United Kingdom;Italy | ||
| 145 | EUCTR2020-001157-48-GB (EUCTR) | 28/07/2020 | 09/07/2020 | PIPAH study: Using imatinib (drug) in Pulmonary Arterial Hypertension | Identifying a safe and tolerated dose of Imatinib forpatients with Pulmonary Arterial Hypertension (PAH) - Positioning Imatinib for Pulmonary Arterial Hypertension (PIPAH) | Pulmonary Arterial Hypertension (Idiopathic, heritable, or assosicated with anorexigens) MedDRA version: 21.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10050701;Term: Congenital pulmonary hypertension;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Imatinib mesilate Product Name: Imatinib mesilate INN or Proposed INN: Imatinib mesilate | Imperial College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 43 | Phase 2 | United Kingdom | ||
| 146 | EUCTR2019-004131-24-HU (EUCTR) | 27/07/2020 | 28/05/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;United Arab Emirates;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 147 | EUCTR2019-002817-21-PT (EUCTR) | 27/07/2020 | 06/02/2020 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged greater or equal than 2 to under 18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Germany;Belarus;Portugal;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Sweden | ||
| 148 | EUCTR2019-003309-88-AT (EUCTR) | 14/07/2020 | 20/02/2020 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Canada;Argentina;Spain;Poland;Belgium;Brazil;Australia;Austria;Germany;United Kingdom;Italy | ||
| 149 | EUCTR2018-001189-40-NL (EUCTR) | 07/07/2020 | 19/12/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-Label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 150 | EUCTR2019-004131-24-PL (EUCTR) | 02/07/2020 | 02/06/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 151 | NCT04503733 (ClinicalTrials.gov) | July 1, 2020 | 24/7/2020 | A Study of GMA301 in Subjects With Pulmonary Arterial Hypertension | A Randomized, Double-blind, Placebo-Controlled, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Q4W GMA301 IV injections (300 mg);Drug: Q4W GMA301 IV injections (600 mg);Drug: Q4W GMA301 IV injections (1000 mg);Other: Q4W placebo IV injections | Gmax Biopharm LLC. | NULL | Recruiting | 18 Years | 75 Years | All | 36 | Phase 1 | United States;China |
| 152 | EUCTR2019-004131-24-IT (EUCTR) | 01/07/2020 | 14/06/2021 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: [JNJ-67896062/ ACT-064992] INN or Proposed INN: MACITENTAN Product Name: MACITENTAN TABLETS Product Code: [JNJ-67896062 / ACT-064992] INN or Proposed INN: MACITENTAN Product Name: MACITENTAN COMPRESSE Product Code: [JNJ-67896062 / ACT-064992] INN or Proposed INN: MACITENTAN | ACTELION PHARMACEUTICALS LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 153 | NCT04273945 (ClinicalTrials.gov) | June 30, 2020 | 31/1/2020 | Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg | Pulmonary Arterial Hypertension | Drug: Macitentan 10 mg;Drug: Macitentan 37.5 mg;Drug: Macitentan 75 mg;Drug: Placebo | Actelion | NULL | Recruiting | 18 Years | N/A | All | 900 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Russian Federation;Saudi Arabia;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Vietnam;Romania |
| 154 | EUCTR2019-002533-11-GB (EUCTR) | 30/06/2020 | 16/03/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden | ||
| 155 | EUCTR2019-002533-11-DE (EUCTR) | 17/06/2020 | 14/02/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 156 | EUCTR2019-004131-24-ES (EUCTR) | 05/06/2020 | 20/07/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;United Arab Emirates;Serbia;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 157 | EUCTR2019-003309-88-ES (EUCTR) | 03/06/2020 | 21/02/2020 | A randomized double blind, placebo controlled study in pulmonary arterial hypertension using cardiopulmonary exercise testing. | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy (ADVANCE Capacity) - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Czech Republic;Argentina;Poland;Brazil;Belgium;Spain;Austria;Australia;Germany;United Kingdom;Italy | ||
| 158 | EUCTR2019-003309-88-GB (EUCTR) | 02/06/2020 | 11/02/2020 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Austria;Australia;Germany;Italy;United Kingdom | ||
| 159 | EUCTR2019-002533-11-DK (EUCTR) | 27/05/2020 | 31/03/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 160 | EUCTR2019-001598-10-PL (EUCTR) | 26/05/2020 | 13/02/2020 | Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension | A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension | Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera | PhaseBio Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Serbia;United States;Czechia;Greece;Spain;Austria;Italy;Hungary;Poland;Belgium;Romania;Bulgaria;Germany | ||
| 161 | EUCTR2019-003309-88-PL (EUCTR) | 14/05/2020 | 26/02/2020 | A Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity in Subjects with Pulmonary Hypertension | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Argentina;Belgium;Spain;Brazil;Poland;Austria;Australia;Germany;United Kingdom;Italy | ||
| 162 | EUCTR2019-002533-11-HU (EUCTR) | 10/05/2020 | 11/03/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United States;Portugal;Taiwan;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan;Sweden | ||
| 163 | EUCTR2019-002533-11-CZ (EUCTR) | 07/05/2020 | 11/03/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden | ||
| 164 | EUCTR2019-002533-11-SE (EUCTR) | 06/05/2020 | 13/03/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 165 | EUCTR2019-003309-88-IT (EUCTR) | 06/05/2020 | 24/05/2021 | na | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: [APD811] INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: [APD811] INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: [APD811] INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 | UNITED THERAPEUTICS CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 193 | Phase 3 | United States;Czechia;Argentina;Spain;Poland;Belgium;Brazil;Austria;Australia;Germany;United Kingdom;Italy | ||
| 166 | ChiCTR2000032622 | 2020-05-01 | 2020-05-04 | Research for right cardiac function evaluation and warning model of neonatal pulmonary arterial hypertension | Research for right cardiac function evaluation and warning model of neonatal pulmonary arterial hypertension | pulmonary arterial hypertension | Gold Standard:Clinical outcome;Index test:echocardiographic; | Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital | NULL | Pending | Male | Target condition:100;Difficult condition:0 | China | |||
| 167 | EUCTR2019-002817-21-IT (EUCTR) | 22/04/2020 | 17/06/2021 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel- Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: [JNJ-67896049 (ACT-293987)] Product Name: Selexipag Product Code: [JNJ-67896049 (ACT-293987)] | ACTELION PHARMACEUTICALS LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Sweden | ||
| 168 | EUCTR2019-002817-21-DE (EUCTR) | 16/04/2020 | 30/10/2019 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden | ||
| 169 | EUCTR2019-002533-11-IT (EUCTR) | 15/04/2020 | 15/06/2021 | A Randomized Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period with Macitentan 75 mg. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg - UNISUS | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan tablets Product Code: [JNJ-67896062 / ACT-064992] INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: [JNJ-67896062 / ACT-064992] INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: [JNJ-67896062 / ACT-064992] INN or Proposed INN: MACITENTAN | ACTELION PHARMACEUTICALS LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Norway;Germany;Japan;Sweden | ||
| 170 | EUCTR2018-001189-40-CZ (EUCTR) | 11/03/2020 | 27/11/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 171 | NCT04278404 (ClinicalTrials.gov) | March 5, 2020 | 18/2/2020 | Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs | Coronavirus Infection (COVID-19);Pulmonary Arterial Hypertension;Urinary Tract Infections in Children;Hypertension;Pain;Hyperphosphatemia;Primary Hyperaldosteronism;Edema;Hypokalemia;Heart Failure;Hemophilia;Menorrhagia;Insomnia;Pneumonia;Skin Infection;Arrythmia;Asthma in Children;Bronchopulmonary Dysplasia;Adrenal Insufficiency;Fibrinolysis; Hemorrhage;Attention Deficit Hyperactivity Disorder;Multisystem Inflammatory Syndrome in Children (MIS-C);Kawasaki Disease;Coagulation Disorder;Down Syndrome | Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: | Duke University | The Emmes Company, LLC;Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Recruiting | 0 Years | 20 Years | All | 5000 | United States;Canada | |
| 172 | NCT04309838 (ClinicalTrials.gov) | March 2020 | 20/2/2020 | Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial Hypertension | LENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;PAH | Combination Product: Treprostinil via implanted pump | University Medicine Greifswald | OMT GmbH & Co. KG | Not yet recruiting | 18 Years | N/A | All | 30 | Germany | |
| 173 | EUCTR2019-001598-10-ES (EUCTR) | 28/02/2020 | 20/12/2019 | Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension | A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension | Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera | PhaseBio Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 174 | EUCTR2019-001598-10-GR (EUCTR) | 28/02/2020 | 13/12/2019 | Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension | A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension | Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera | PhaseBio Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 175 | EUCTR2019-001598-10-BG (EUCTR) | 12/02/2020 | 09/01/2020 | Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension | A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension | Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera | PhaseBio Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 176 | EUCTR2019-002817-21-BG (EUCTR) | 11/02/2020 | 06/01/2020 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Other descriptive name: Selexipag Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Other descriptive name: Selexipag | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Malaysia;Viet Nam;Denmark;Australia;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;Sweden | ||
| 177 | EUCTR2019-002817-21-HU (EUCTR) | 05/02/2020 | 29/11/2019 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden | ||
| 178 | NCT03926793 (ClinicalTrials.gov) | February 4, 2020 | 22/4/2019 | Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension | A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: GB002;Drug: Placebo;Device: Generic Dry Powder Inhaler | GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | NULL | Completed | 18 Years | 75 Years | All | 8 | Phase 1 | United States;United Kingdom |
| 179 | EUCTR2019-001598-10-HU (EUCTR) | 24/01/2020 | 10/12/2019 | Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension | A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension | Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera | PhaseBio Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Serbia;United States;Greece;Spain;Austria;Italy;Hungary;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 180 | NCT04175600 (ClinicalTrials.gov) | January 16, 2020 | 8/11/2019 | A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged >=2 to <18 Years With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Selexipag;Drug: Placebo | Actelion | NULL | Recruiting | 2 Years | 17 Years | All | 237 | Phase 3 | Turkey;United States;Australia;Belarus;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Croatia;Finland;France;Germany;Hungary;Ireland;Israel;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Taiwan;Thailand;Ukraine;Vietnam;Argentina;Austria;Denmark |
| 181 | EUCTR2019-002817-21-ES (EUCTR) | 07/01/2020 | 11/11/2019 | A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents. | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 237 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden | ||
| 182 | ChiCTR1900028152 | 2020-01-01 | 2019-12-13 | Serum interleukins-6: a predictive biomarker for connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) | Serum interleukins-6: a predictive biomarker for connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) | pulmonary arterial hypertension | Gold Standard:Clinical outcome;Index test:serum IL-6; | Zhongda Hospital Affiliated to Southeast University | NULL | Pending | 18 | 80 | Both | Target condition:200;Difficult condition:0 | N/A | China |
| 183 | EUCTR2019-002414-40-GB (EUCTR) | 17/12/2019 | 24/10/2019 | An extension study, at multiple study sites, for patients with Pulmonary Arterial Hypertension who took part in study CXA-10-301, to look at the continuing safety of CXA-10 and how well it works long term: all patients will receive CXA-10 treatment. | A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects with Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301. - Open label extension of CXA-10 in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension (PAH). MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: CXA-10 Product Code: CXA-10 INN or Proposed INN: 10-nitro-9(E)-octadec-9-enoic acid | Complexa Inc. | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 2 | United States;United Kingdom | ||
| 184 | EUCTR2018-002796-18-IT (EUCTR) | 28/11/2019 | 29/01/2021 | To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH. | An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease - Safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: zamicastat Product Code: [BIA-5-1058] INN or Proposed INN: zamicastat | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 185 | NCT03782818 (ClinicalTrials.gov) | November 20, 2019 | 17/12/2018 | Olaparib for PAH: a Multicenter Clinical Trial | Olaparib for Pulmonary Arterial Hypertension: a Multicenter Clinical Trial | Pulmonary Arterial Hypertension | Drug: Olaparib | Laval University | Canadian Institutes of Health Research (CIHR);AstraZeneca | Recruiting | 18 Years | 75 Years | All | 20 | Phase 1/Phase 2 | Canada |
| 186 | NCT03884465 (ClinicalTrials.gov) | November 11, 2019 | 4/3/2019 | Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil | A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects | Pulmonary Arterial Hypertension | Drug: Inhaled dry powder treprostinil (LIQ861) | Liquidia Technologies, Inc. | FGK Clinical Research GmbH | Recruiting | 18 Years | N/A | All | 32 | Phase 2 | France;Germany |
| 187 | EUCTR2018-002448-10-DE (EUCTR) | 08/11/2019 | 17/08/2018 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Portugal;France;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 188 | NCT04125745 (ClinicalTrials.gov) | October 31, 2019 | 28/8/2018 | Oral CXA-10 in Pulmonary Arterial Hypertension | Phase 2 Open-Label Study of Safety and Efficacy Trial of CXA-10 in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: CXA-10 | Gladwin, Mark, MD | National Heart, Lung, and Blood Institute (NHLBI);Complexa, Inc. | Terminated | 18 Years | 80 Years | All | 2 | Phase 2 | United States |
| 189 | EUCTR2018-002448-10-IT (EUCTR) | 29/10/2019 | 01/02/2021 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: zamicastat Product Code: [BIA 5-1058] INN or Proposed INN: zamicastat | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 190 | NCT05318950 (ClinicalTrials.gov) | October 20, 2019 | 10/12/2021 | A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon | A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon: Effect on quaLity of Life | Pulmonary Arterial Hypertension | Behavioral: E-learning;Dietary Supplement: Diet | Amsterdam UMC, location VUmc | Reinier de Graaf Groep;Janssen-Cilag B.V. | Completed | 18 Years | 80 Years | All | 40 | N/A | Netherlands |
| 191 | EUCTR2014-004786-25-BG (EUCTR) | 11/10/2019 | 01/07/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: CJNJ-68150420-ZZZ-G001 (ACT-064992D) INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 192 | NCT03683186 (ClinicalTrials.gov) | September 23, 2019 | 19/9/2018 | A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH) | PAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease | Drug: Ralinepag | United Therapeutics | NULL | Enrolling by invitation | 18 Years | N/A | All | 1000 | Phase 3 | Poland;Portugal;Romania;Serbia;Singapore;Spain;Taiwan;Turkey;Ukraine;United Kingdom;United States;Sweden;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands |
| 193 | NCT03950739 (ClinicalTrials.gov) | September 17, 2019 | 9/5/2019 | Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso | An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using Tyvaso | Pulmonary Arterial Hypertension | Drug: Treprostinil Inhalation Powder | United Therapeutics | NULL | Active, not recruiting | 18 Years | N/A | All | 51 | Phase 1 | United States |
| 194 | EUCTR2014-004786-25-DE (EUCTR) | 05/09/2019 | 02/05/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: CJNJ-68150420-ZZZ-G001 (ACT- 064992D) INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Brazil;Malaysia;Poland;Australia;South Africa;Bulgaria;Germany;China;Japan | ||
| 195 | EUCTR2018-001187-33-PT (EUCTR) | 02/09/2019 | 22/03/2019 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 196 | EUCTR2018-001189-40-PT (EUCTR) | 02/09/2019 | 27/03/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutic Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 197 | EUCTR2019-001699-12-GB (EUCTR) | 27/08/2019 | 30/07/2019 | Relative bioavailability study of marketed and lower dose ambrisentan in healthy adult participants | An open-label, randomized three period cross-over relative bioavailability study to compare the pharmacokinetic parameters of a lower dose formulation of ambrisentan (GSK1325760) with marketed ambrisentan in healthy adult participants | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ambrisentan Tablet Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid Trade Name: Volibris Product Name: Ambrisentan 5mg film-coated tablets [marketed product] INN or Proposed INN: AMBRISENTAN Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1 | United Kingdom | ||
| 198 | NCT03655704 (ClinicalTrials.gov) | August 22, 2019 | 28/8/2018 | Apabetalone for Pulmonary Arterial Hypertension: a Pilot Study | Apabetalone for Pulmonary Arterial Hypertension: a Pilot Study | Pulmonary Arterial Hypertension | Drug: Apabetalone | Steeve Provencher | Resverlogix Corp | Completed | 18 Years | 75 Years | All | 7 | Early Phase 1 | Canada |
| 199 | EUCTR2018-003093-27-GB (EUCTR) | 16/08/2019 | 12/06/2019 | Clinical Study of Inhaled GB002 for the Treatment of WHO Group I Pulmonary Arterial Hypertension (PAH) | A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH) - GB002 in Adult Subjects with PAH | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: GB002 | GB002, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Denmark;Netherlands;United Kingdom;Sweden | ||
| 200 | EUCTR2014-004786-25-ES (EUCTR) | 13/08/2019 | 11/06/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: ACT-064992D INN or Proposed INN: MACITENTAN INN or Proposed INN: TADALAFIL Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United States;Taiwan;Spain;Turkey;Russian Federation;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Malaysia;Brazil;Australia;Bulgaria;Germany;Japan;China | ||
| 201 | EUCTR2014-004786-25-PL (EUCTR) | 10/08/2019 | 28/05/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: CJNJ-68150420-ZZZ-G001(ACT-064992D) INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 202 | NCT04053543 (ClinicalTrials.gov) | August 9, 2019 | 19/7/2019 | CXA-10 Study in Subjects With Pulmonary Arterial Hypertension | A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects With Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301 | PAH | Drug: CXA-10 | Complexa, Inc. | Medpace, Inc.;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Terminated | 18 Years | N/A | All | 33 | Phase 2 | United States;United Kingdom |
| 203 | EUCTR2014-004786-25-IT (EUCTR) | 06/08/2019 | 17/06/2021 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy - Nap | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: CJNJ-68150420-ZZZ-G001 (ACT- 064992D) Product Code: [CJNJ-68150420-ZZZ-G001 (ACT- 064992D)] INN or Proposed INN: MACITENTAN Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera INN or Proposed INN: TADALAFIL Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera Trade Name: Adcirca® Product Name: G04BE08 Product Code: [G04BE08] INN or Proposed INN: TADALAFIL Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera Trade Name: Opsumit® Product Name: macitentan Product Code: [ACT-064992] INN or Proposed INN: MACITENTAN | ACTELION PHARMACEUTICALS LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 204 | NCT04055415 (ClinicalTrials.gov) | August 1, 2019 | 8/8/2019 | Clinical Study of Adipose Derived Mesenchymal Stem Cells for Treatment of Pulmonary Arterial Hypertension | Safety and Efficacy of Transplantation of Adipose Derived Mesenchymal Stem Cells to Treat Pulmonary Arterial Hypertension | Pulmonary Hypertension | Biological: adipose derived mesenchymal stem cells;Drug: Conventional drug therapy(expectorant,bronchodilator) | Liaocheng People's Hospital | NULL | Recruiting | 40 Years | 75 Years | All | 60 | Phase 1/Phase 2 | China |
| 205 | NCT03924154 (ClinicalTrials.gov) | August 1, 2019 | 5/4/2019 | A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1) | A Phase 2a, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: RVT-1201;Drug: Placebo | Altavant Sciences GmbH | Altavant Sciences, Inc.;PPD | Terminated | 18 Years | 75 Years | All | 3 | Phase 2 | United States;Canada |
| 206 | NCT05343637 (ClinicalTrials.gov) | July 30, 2019 | 4/4/2022 | A Dose Escalation Study to Evaluate the Effect of RT234 in Subjects With Pulmonary Arterial Hypertension | A Phase 2a, Dose Escalation Study to Evaluate the Effect of RT234 on Cardiopulmonary Hemodynamics in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI) | Respira Therapeutics, Inc. | NULL | Completed | 18 Years | 80 Years | All | 14 | Phase 2 | Australia |
| 207 | EUCTR2018-002796-18-PT (EUCTR) | 30/07/2019 | 30/10/2018 | To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH. | An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA-5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 208 | NCT03904693 (ClinicalTrials.gov) | July 29, 2019 | 4/4/2019 | Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy | Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) | Drug: FDC macitentan/tadalafil;Drug: Macitentan 10 mg;Drug: Tadalafil 40 mg;Drug: Placebo FDC;Drug: Placebo macitentan;Drug: Placebo tadalafil | Actelion | NULL | Active, not recruiting | 18 Years | N/A | All | 187 | Phase 3 | United States;Australia;Brazil;Bulgaria;Canada;China;Czechia;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;South Africa;Spain;Taiwan;Turkey |
| 209 | NCT03992755 (ClinicalTrials.gov) | July 18, 2019 | 5/6/2019 | Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil | A Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients | Primary Pulmonary Hypertension | Drug: LIQ861 Inhaled Treprostinil | Liquidia Technologies, Inc. | Nuventra, Inc. | Active, not recruiting | 18 Years | N/A | All | 92 | Phase 3 | United States |
| 210 | NCT03863990 (ClinicalTrials.gov) | July 15, 2019 | 19/2/2019 | Study Performed at Various Medical Centers to Learn More About Survival and Expected Course of Pulmonary Arterial Hypertension, a Type of High Blood Pressure in the Lungs Related to the Narrowing of the Small Blood Vessels in the Lungs | Survival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START) | Pulmonary Arterial Hypertension | Drug: PAH medication | Bayer | NULL | Completed | 18 Years | N/A | All | 104 | Argentina | |
| 211 | EUCTR2016-001062-28-FI (EUCTR) | 03/07/2019 | 03/07/2019 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, study with single-arm extension period to assess the pharmacokinetics, safety and efficacy of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Israel;Russian Federation;Colombia;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Viet Nam;Australia;South Africa;China;Korea, Republic of | ||
| 212 | NCT04316143 (ClinicalTrials.gov) | June 6, 2019 | 18/3/2020 | Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH | An Open-label, Multicentre Study to Evaluate Pharmacokinetics, Safety and Efficacy of Zamicastat as Adjunctive Therapy in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Zamicastat | Bial - Portela C S.A. | NULL | Completed | 18 Years | 65 Years | All | 33 | Phase 2 | Spain |
| 213 | EUCTR2018-001189-40-HR (EUCTR) | 21/05/2019 | 05/06/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 214 | EUCTR2018-001187-33-HR (EUCTR) | 20/05/2019 | 05/06/2019 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 215 | EUCTR2016-001067-36-PL (EUCTR) | 08/05/2019 | 18/02/2019 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 216 | NCT03554291 (ClinicalTrials.gov) | May 1, 2019 | 31/5/2018 | Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension | Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension | Pulmonary Arterial Hypertension;Right Heart Failure | Drug: Famotidine 20 MG;Other: Placebo | University of Washington | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 18 Years | 80 Years | All | 80 | Phase 2 | United States |
| 217 | NCT03835676 (ClinicalTrials.gov) | May 1, 2019 | 6/2/2019 | Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension | Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Treprostinil | Magdi H. Yacoub | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | Egypt |
| 218 | EUCTR2018-001187-33-NL (EUCTR) | 16/04/2019 | 18/12/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag To Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 219 | NCT03795428 (ClinicalTrials.gov) | April 10, 2019 | 18/12/2018 | Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004 | A Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004 | Pulmonary Arterial Hypertension | Drug: Pemziviptadil (PB1046) Injection | PhaseBio Pharmaceuticals Inc. | NULL | Recruiting | 18 Years | 79 Years | All | 63 | Phase 2 | United States |
| 220 | EUCTR2018-001189-40-BG (EUCTR) | 10/04/2019 | 29/01/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 221 | EUCTR2018-001187-33-BG (EUCTR) | 10/04/2019 | 13/12/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 222 | EUCTR2018-001187-33-GR (EUCTR) | 03/04/2019 | 20/03/2019 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to ImproveTreatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 223 | EUCTR2018-001187-33-GB (EUCTR) | 03/04/2019 | 31/10/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;Bulgaria;Croatia;Argentina;Romania;Hungary;Ukraine;United Kingdom;Canada;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Israel;Australia;Germany | ||
| 224 | EUCTR2018-001189-40-GR (EUCTR) | 03/04/2019 | 20/03/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 225 | JPRN-UMIN000035389 | 2019/04/01 | 01/04/2019 | Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension | Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension - SETOUCHI PH study | Pulmonary arterial hypertension | Dose: macitentan 10 mg/day+riociguat 3 mg/day. Max dose of riociguat is 7.5 mg/day.Intervention period: 8 month Dose: macitentan 10 mg/day+selexipag 0.4 mg/day. Max dose of selexipag is 3.2 mg/day. Intervention period: 8 month | Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 76 | Not selected | Japan |
| 226 | NCT04062565 (ClinicalTrials.gov) | March 25, 2019 | 29/3/2019 | Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH | A Prospective Trial to Evaluate Up-front Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Patients With Advanced Pulmonary Arterial Hypertension (IIR-3810) | Pulmonary Arterial Hypertension | Drug: Treprostinil Injectable Product;Drug: Riociguat Pill | University of Arizona | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 3 | United States |
| 227 | NCT03522935 (ClinicalTrials.gov) | March 18, 2019 | 1/2/2018 | Subcutaneous Elafin in Healthy Subjects | Safety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal Subjects | Pulmonary Arterial Hypertension | Drug: Elafin;Drug: Placebo | Roham T. Zamanian | Duke University;SRI International | Completed | 18 Years | 55 Years | All | 30 | Phase 1 | United States |
| 228 | EUCTR2018-001187-33-DE (EUCTR) | 18/03/2019 | 29/10/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;Bulgaria;Croatia;Argentina;Romania;Hungary;Ukraine;United Kingdom;Canada;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Israel;Australia;Germany | ||
| 229 | EUCTR2018-001387-39-DE (EUCTR) | 15/03/2019 | 30/01/2019 | The effect of oxygen therapy in patients with pulmonary Hypertension. | A prospective, randomized, controlled trial to assess the effect of long-term oxygen therapy on 6-minute walking distance, clinical parameters and hemodynamics in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) - SOPHA | pulmonary arterial hypertension (PAH) and chronic thromboembolicpulmonary hypertension (CTEPH);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Oxygen, liquid INN or Proposed INN: OXYGEN Other descriptive name: Sauerstoff | Thoraxklinik-Heidelberg gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Germany | ||
| 230 | EUCTR2018-002796-18-GB (EUCTR) | 12/03/2019 | 19/06/2019 | To study the safety and how effective Long-term Zamicastat treatment is for Pulmonary Arterial Hypertension | An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease. - Safety and efficacy of BIA 5-1058 in PAH | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: Zamicastat | Bial - Portela & Ca, S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | Portugal;Belgium;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom | ||
| 231 | JPRN-JapicCTI-194651 | 12/3/2019 | 05/03/2019 | MD-711 Phase 2/3 Study in PAH | MD-711 Phase 2/3 Study in Pulmonary Arterial Hypertension | Pulmonary arterial hypertension | Intervention name : MD-711 INN of the intervention : treprostinil Dosage And administration of the intervention : Inhaled admistration Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Mochida Pharmaceutical Co., Ltd. | NULL | complete | 18 | 75 | BOTH | 15 | Phase 2-3 | Japan |
| 232 | EUCTR2018-001189-40-GB (EUCTR) | 11/03/2019 | 26/11/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;France;Bulgaria;Croatia;Argentina;Hungary;Ukraine;United Kingdom;Canada;Czech Republic;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Italy;Israel;Australia | ||
| 233 | EUCTR2018-001189-40-BE (EUCTR) | 05/03/2019 | 10/12/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag inSubjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;France;Bulgaria;Croatia;Argentina;Hungary;Ukraine;United Kingdom;Canada;Czech Republic;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Italy;Israel;Australia | ||
| 234 | NCT03789643 (ClinicalTrials.gov) | March 2019 | 26/12/2018 | Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial Hypertension | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants With Pulmonary Arterial Hypertension (RELIEF-PAH) | Pulmonary Arterial Hypertension | Drug: JTT-251;Drug: Placebo | Akros Pharma Inc. | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 2 | NULL |
| 235 | EUCTR2018-001189-40-IT (EUCTR) | 21/02/2019 | 14/11/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 236 | EUCTR2018-001189-40-DK (EUCTR) | 20/02/2019 | 11/12/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 237 | EUCTR2018-001187-33-BE (EUCTR) | 18/02/2019 | 10/12/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 238 | EUCTR2018-001189-40-FR (EUCTR) | 15/02/2019 | 16/11/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden | ||
| 239 | EUCTR2018-002448-10-GB (EUCTR) | 11/02/2019 | 19/06/2019 | Multi centre study to assess the safety, effective and movement of Zamicastat within the body when given to a patient with pulmonary arterial hypertension as an additional medication. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmcokinetics, safety and efficacy of BIA-5-1058 in PAH | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 | Bial - Portela & Ca, S.A | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Portugal;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom | ||
| 240 | EUCTR2018-001189-40-SE (EUCTR) | 11/02/2019 | 19/11/2018 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 241 | EUCTR2018-001187-33-SE (EUCTR) | 05/02/2019 | 29/10/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 242 | EUCTR2018-003414-40-DE (EUCTR) | 31/01/2019 | 06/11/2018 | A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension Patients | A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects | Pulmonary Arterial Hypertension (WHO Group 1) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: LIQ861 26.5 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 53 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 79.5 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 106 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: Nitric Oxide INN or Proposed INN: NITRIC OXIDE | Liquidia Technologies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | France;Germany | ||
| 243 | EUCTR2018-001187-33-DK (EUCTR) | 29/01/2019 | 26/11/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Singapore;United States;Portugal;Greece;Sweden;Netherlands;China;Brazil;Korea, Republic of;Poland;Chile;Serbia;Bulgaria;Croatia;Argentina;Romania;Hungary;Ukraine;United Kingdom;Canada;Turkey;Belgium;European Union;Taiwan;Denmark;Mexico;Israel;Australia;Germany | ||
| 244 | EUCTR2018-003414-40-FR (EUCTR) | 21/01/2019 | 06/11/2018 | A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension Patients | A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects | Pulmonary Arterial Hypertension (WHO Group 1) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: LIQ861 25 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 50 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 75 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 100 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM | Liquidia Technologies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | France;Germany | ||
| 245 | NCT03754660 (ClinicalTrials.gov) | January 21, 2019 | 23/11/2018 | This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | A Non-randomized Two Part Multi-center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel-group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592 | Hypertension, Pulmonary | Drug: BAY1237592 | Bayer | NULL | Completed | 18 Years | 80 Years | All | 38 | Phase 1 | Austria;Czechia;Germany;Poland |
| 246 | NCT03744637 (ClinicalTrials.gov) | January 18, 2019 | 13/11/2018 | A Study of Single Doses of MK -5475 on Pulmonary Vascular Resistance (MK-5475-002) | A Study to Assess the Effect of Single Doses of MK -5475 on Pulmonary Vascular Resistance in Patients With Moderate to Severe Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: MK-5475;Drug: Placebo | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 70 Years | All | 25 | Phase 1 | Moldova, Republic of |
| 247 | EUCTR2018-002796-18-ES (EUCTR) | 17/01/2019 | 16/11/2018 | To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH. | An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA-5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;Spain;Ukraine;Austria;United Kingdom | ||
| 248 | EUCTR2018-001189-40-PL (EUCTR) | 16/01/2019 | 21/03/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-Label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Sweden | ||
| 249 | EUCTR2018-001187-33-PL (EUCTR) | 16/01/2019 | 06/12/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 250 | EUCTR2018-001189-40-HU (EUCTR) | 14/01/2019 | 21/01/2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A study evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;United States;Serbia;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Sweden | ||
| 251 | EUCTR2018-001187-33-HU (EUCTR) | 14/01/2019 | 06/11/2018 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A Study Evaluating the EffiCacy and Safety of Ralinepag To Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden | ||
| 252 | NCT03648385 (ClinicalTrials.gov) | January 9, 2019 | 10/8/2018 | Effects of DHEA in Pulmonary Hypertension | Effects of DHEA in Pulmonary Hypertension | Pulmonary Arterial Hypertension | Drug: DHEA tablet;Other: Placebo | Rhode Island Hospital | NULL | Recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States |
| 253 | EUCTR2017-004738-27-BE (EUCTR) | 04/01/2019 | 31/08/2018 | A Phase 2 Study of Sotatercept for the Treatment of PAH | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Brazil;Spain;Belgium;Australia;Israel;Germany;United Kingdom | ||
| 254 | EUCTR2018-002796-18-AT (EUCTR) | 20/12/2018 | 06/11/2018 | To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH. | An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA-5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 255 | NCT03657095 (ClinicalTrials.gov) | December 10, 2018 | 18/5/2018 | A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension | An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension Patients | Pulmonary Arterial Hypertension | Drug: Esuberaprost;Drug: Placebo | Lung Biotechnology PBC | NULL | Terminated | 18 Years | 85 Years | All | 112 | Phase 3 | United States;Israel |
| 256 | EUCTR2018-002448-10-PT (EUCTR) | 26/11/2018 | 04/09/2018 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Portugal;Spain;Belgium;Ukraine;Austria;Netherlands;Germany;United Kingdom;Italy | ||
| 257 | EUCTR2018-002448-10-ES (EUCTR) | 21/11/2018 | 09/10/2018 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Ukraine;Austria | ||
| 258 | NCT04041648 (ClinicalTrials.gov) | November 9, 2018 | 23/7/2019 | Single Ascending Dose Study for Evaluation of Safety, Tolerability and Pharmacokinetics of L606 | A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose of L606 for Inhalation in Healthy Subjects | Pulmonary Arterial Hypertension | Drug: L606 (Liposomal Treprostinil) Inhalation Solution 51ug;Device: L606 Inhalation System;Other: Placebo Solution | Pharmosa Biopharm Inc. | PPD | Recruiting | 18 Years | 50 Years | All | 64 | Phase 1 | United States |
| 259 | EUCTR2018-002448-10-AT (EUCTR) | 31/10/2018 | 08/08/2018 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058 | Bial - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy | ||
| 260 | EUCTR2018-000145-39-DE (EUCTR) | 25/10/2018 | 05/06/2018 | A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension | A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;United States;Taiwan;Ukraine;Israel;Russian Federation;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Belgium;Malaysia;Singapore;Romania;Netherlands;Germany;China | ||
| 261 | NCT03251872 (ClinicalTrials.gov) | October 25, 2018 | 13/8/2017 | Olaparib for PAH: a Pilot Study | Olaparib for Pulmonary Arterial Hypertension: a Pilot Clinical Study | Pulmonary Arterial Hypertension | Drug: Olaparib | Laval University | NULL | Terminated | 18 Years | 75 Years | All | 6 | Early Phase 1 | Canada |
| 262 | EUCTR2018-000145-39-GB (EUCTR) | 22/10/2018 | 28/03/2018 | A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension | A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Malaysia;Poland;Singapore;Romania;Germany;Netherlands;China | ||
| 263 | EUCTR2017-004738-27-GB (EUCTR) | 18/10/2018 | 24/06/2019 | A Phase 2 Study of Sotatercept for the Treatment of PAH | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom | ||
| 264 | EUCTR2013-004362-34-LV (EUCTR) | 03/10/2018 | 02/07/2018 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden | ||
| 265 | EUCTR2017-000216-42-FR (EUCTR) | 27/09/2018 | 23/07/2018 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Germany;United Kingdom;Switzerland;Sweden | ||
| 266 | EUCTR2017-004738-27-ES (EUCTR) | 04/09/2018 | 05/09/2018 | A Phase 2 Study of Sotatercept for the Treatment of PAH | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;France;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom | ||
| 267 | NCT03626688 (ClinicalTrials.gov) | August 30, 2018 | 27/7/2018 | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH | PAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease | Drug: Ralinepag;Drug: Placebo | United Therapeutics | NULL | Recruiting | 18 Years | N/A | All | 1000 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Romania;Serbia;Singapore;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom |
| 268 | EUCTR2015-005223-90-BE (EUCTR) | 16/08/2018 | 24/05/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 269 | EUCTR2017-004738-27-DE (EUCTR) | 15/08/2018 | 03/08/2018 | A Phase 2 Study of Sotatercept for the Treatment of PAH | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc | Acceleron Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;France;Spain;Brazil;Belgium;Australia;Israel;Germany;United Kingdom | ||
| 270 | NCT03449524 (ClinicalTrials.gov) | August 1, 2018 | 14/2/2018 | PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH) | Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension | PAH | Drug: 75mg CXA-10;Drug: 150mg CXA-10;Other: Placebo | Complexa, Inc. | Medpace, Inc.;Philips Healthcare;Cardiovascular Clinical Science Foundation;MicroConstants;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Terminated | 18 Years | 80 Years | All | 69 | Phase 2 | United States;United Kingdom |
| 271 | NCT03602781 (ClinicalTrials.gov) | August 2018 | 6/7/2018 | Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric | Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Withdrawal Study of Pulmonary Arterial Hypertension(PAH) Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric Oxide (INO) | Pulmonary Arterial Hypertension | Drug: Placebo;Drug: iNO | Bellerophon Pulse Technologies | Worldwide Clinical Trials | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | United States;Canada |
| 272 | NCT03492177 (ClinicalTrials.gov) | July 23, 2018 | 3/4/2018 | A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension | A Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: selexipag (Uptravi) | Actelion | NULL | Active, not recruiting | 2 Years | 17 Years | All | 63 | Phase 2 | United States;Belarus;Belgium;Canada;China;France;Germany;Hungary;Israel;Malaysia;Poland;Russian Federation;Serbia;Taiwan;Ukraine;United Kingdom;Romania |
| 273 | EUCTR2018-000145-39-HU (EUCTR) | 03/07/2018 | 18/07/2018 | A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension | A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 2 | Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China | ||
| 274 | EUCTR2015-003438-28-GB (EUCTR) | 21/06/2018 | 13/11/2017 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 275 | NCT03496207 (ClinicalTrials.gov) | June 13, 2018 | 29/3/2018 | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Placebo;Drug: Sotatercept | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Completed | 18 Years | N/A | All | 106 | Phase 2 | United States;Australia;Brazil;France;Germany;Israel;Spain;United Kingdom |
| 276 | NCT03683082 (ClinicalTrials.gov) | June 5, 2018 | 20/9/2018 | Oxygen Treatment and Pulmonary Arterial Hypertension | Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients | Pulmonary Arterial Hypertension | Drug: Oxygen supplementation;Drug: Sham O2 (medical air) | George Papanicolaou Hospital | NULL | Unknown status | 18 Years | 80 Years | All | 10 | N/A | Greece |
| 277 | NCT03708146 (ClinicalTrials.gov) | May 28, 2018 | 12/10/2018 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058 | A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of BIA 5 1058 in Healthy Volunteers | Cardiovascular Disease+Pulmonary Disease;Pulmonary Arterial Hypertension | Drug: BIA 5-1058;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | All | 157 | Phase 1 | United Kingdom |
| 278 | EUCTR2017-000216-42-PT (EUCTR) | 14/05/2018 | 03/11/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;France;Portugal;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 279 | NCT03489005 (ClinicalTrials.gov) | April 9, 2018 | 29/3/2018 | Effect of BIA 5 1058 on Cardiac Repolarization | A Randomized, Double-blind, Placebo-controlled and Open-label, Active Controlled, 4 Period Crossover Trial to Evaluate the Effect of BIA 5 1058 on Cardiac Repolarization in Healthy Adult Males and Females Under Fed Conditions | Cardiovascular Disease;Pulmonary Arterial Hypertension;Heart Failure | Drug: BIA 5-1058;Drug: Placebo Oral Tablet;Drug: Moxifloxacin 400 mg | Bial - Portela C S.A. | Covance | Completed | 18 Years | 55 Years | All | 49 | Phase 1 | United Kingdom |
| 280 | NCT03422328 (ClinicalTrials.gov) | April 5, 2018 | 30/1/2018 | A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies. | mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies | Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary Hypertension | Drug: macitentan | Actelion | NULL | Enrolling by invitation | N/A | N/A | All | 150 | Phase 3 | Belarus;Belgium;France;Poland;Russian Federation;Turkey;Ukraine |
| 281 | NCT03344159 (ClinicalTrials.gov) | April 1, 2018 | 28/9/2017 | Spironolactone Therapy in Chronic Stable Right HF Trial | Spironolactone Therapy in Chronic Stable Right HF Trial | Chronic Right-Sided Heart Failure;Pulmonary Arterial Hypertension;Pulmonary Hypertension, Primary, 2;Pulmonary Hypertension, Primary, 3;Pulmonary Hypertension, Primary, 4;Cardiomyopathy Right Ventricular | Drug: Spironolactone;Drug: Placebo;Radiation: PET/CT Scan: Two PET scans using 1. C-11 HED and 2. N-13 Ammonia or rubidium-82;Diagnostic Test: Cardiac MRI (Gadolinium enhanced) | Ottawa Heart Institute Research Corporation | NULL | Completed | 18 Years | N/A | All | 15 | Phase 4 | Canada |
| 282 | NCT04994860 (ClinicalTrials.gov) | March 22, 2018 | 29/7/2021 | Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Sildenafil | An Open-Label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Sildenafil in Healthy Subjects Under Fasting Conditions | Pulmonary Arterial Hypertension | Drug: BIA 5-1058;Drug: Sildenafil | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 20 | Phase 1 | Germany |
| 283 | EUCTR2017-003934-10-FR (EUCTR) | 19/03/2018 | 19/01/2018 | A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary arterial hypertension and who were previously treated with macitentan in clinical studies. | mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary arterial hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 94 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 284 | NCT03464864 (ClinicalTrials.gov) | March 9, 2018 | 1/3/2018 | Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers | A Phase 1, Single-center, Open-label, Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder (TrIP) in Healthy Normal Volunteers | Pulmonary Arterial Hypertension | Drug: Treprostinil Inhalation Powder | Mannkind Corporation | NULL | Completed | 18 Years | 55 Years | All | 36 | Phase 1 | United States |
| 285 | NCT03362047 (ClinicalTrials.gov) | March 1, 2018 | 22/11/2017 | (RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment) | Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen Bedingungen | Pulmonary Arterial Hypertension (PAH) | Drug: Riciguat Group;Drug: Macitentan Group | University of Giessen | Philipps University Marburg Medical Center | Recruiting | 18 Years | 85 Years | All | 30 | Phase 2 | Germany |
| 286 | NCT04994119 (ClinicalTrials.gov) | February 23, 2018 | 29/7/2021 | Effect of BIA 5-1058 400 mg on Warfarin Pharmacokinetics | An Open-label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5 1058 400 mg on Warfarin Pharmacokinetics in Healthy Subjects Under Fasting Conditions | Pulmonary Arterial Hypertension | Drug: BIA 5-1058;Drug: Warfarin | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 26 | Phase 1 | Germany |
| 287 | NCT03177603 (ClinicalTrials.gov) | February 21, 2018 | 23/5/2017 | A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension (PAH) | An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: GSK2586881 | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 23 | Phase 2 | United States;Germany;Spain |
| 288 | NCT04991207 (ClinicalTrials.gov) | February 6, 2018 | 28/7/2021 | Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan | An Open-label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5 1058 400 mg on the Steady State Pharmacokinetics of Bosentan in Healthy Subjects Under Fasting Conditions | Pulmonary Arterial Hypertension | Drug: BIA 5-1058;Drug: bosentan | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 44 | Phase 1 | Germany |
| 289 | NCT02939599 (ClinicalTrials.gov) | February 1, 2018 | 12/10/2016 | Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients | Long-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: QCC374 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 5 | Phase 2 | United States;Germany;United Kingdom |
| 290 | NCT03293407 (ClinicalTrials.gov) | February 1, 2018 | 20/9/2017 | Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension | Ventavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Iloprost (Ventavis, BAYQ6256);Device: Breelib nebulizer | Bayer | NULL | Completed | 18 Years | N/A | All | 31 | Germany | |
| 291 | EUCTR2015-003438-28-ES (EUCTR) | 19/01/2018 | 01/12/2017 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 292 | EUCTR2016-001411-20-GB (EUCTR) | 12/01/2018 | 09/01/2017 | Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patients | Long-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QCC374 0.015 mg INN or Proposed INN: TBD Product Code: QCC374 0.06 mg INN or Proposed INN: TBD | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | United States;Taiwan;Germany;United Kingdom;Korea, Republic of | ||
| 293 | NCT03399604 (ClinicalTrials.gov) | January 2, 2018 | 3/1/2018 | Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil | A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients | Primary Pulmonary Hypertension | Drug: LIQ861 Inhaled Treprostinil | Liquidia Technologies, Inc. | Nuventra, Inc. | Completed | 18 Years | N/A | All | 121 | Phase 3 | United States |
| 294 | EUCTR2017-000137-31-NL (EUCTR) | 19/12/2017 | 19/07/2017 | Treatment of Pulmonary Hypertension with 6 Mercaptopurine | Pulmonary Hypertension REversal in Clusters of Patients With Identical Pathobiological Substrates. 6-Mercaptopurine Proof-of-Concept Trial - PRECISE-MP | Pulmonary arterial hypertension MedDRA version: 20.0;Level: HLGT;Classification code 10037454;Term: Pulmonary vascular disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Trade Name: Puri-Nethol | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Netherlands | ||
| 295 | NCT03229499 (ClinicalTrials.gov) | December 7, 2017 | 18/7/2017 | Pulmonary Hypertension and Anastrozole Trial | Pulmonary Hypertension and Anastrozole Trial (PHANTOM) | Pulmonary Arterial Hypertension | Drug: Anastrozole;Drug: Placebo Oral Tablet | University of Pennsylvania | National Heart, Lung, and Blood Institute (NHLBI);Johns Hopkins University;University of Colorado, Denver;Rhode Island Hospital;Stanford University;Vanderbilt University;Washington University School of Medicine | Completed | 18 Years | N/A | All | 84 | Phase 2 | United States |
| 296 | NCT03187678 (ClinicalTrials.gov) | December 4, 2017 | 9/6/2017 | Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension | A Multicenter, Open-label, Single-sequence Cross-over Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Switching From an Oral Stable Dose of Selexipag | Pulmonary Arterial Hypertension | Drug: i.v. selexipag;Drug: oral selexipag (Uptravi) | Actelion | NULL | Completed | 18 Years | 75 Years | All | 20 | Phase 3 | United States;Germany |
| 297 | EUCTR2017-000216-42-DE (EUCTR) | 30/11/2017 | 26/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 298 | NCT03364244 (ClinicalTrials.gov) | November 30, 2017 | 30/11/2017 | Revatio Special Investigation for Long-term Use in Pediatric Patients | Revatio Special Investigation - Investigation for Long-Term Use of Revatio in Pediatric Patients | Pulmonary Arterial Hypertension | Drug: Sildenafil | Viatris Pharmaceuticals Japan Inc | NULL | Completed | 0 Years | 14 Years | All | 1023 | Japan | |
| 299 | NCT03078907 (ClinicalTrials.gov) | November 8, 2017 | 6/3/2017 | Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension. | A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their Impacts | Pulmonary Arterial Hypertension | Drug: Selexipag;Drug: Placebo | Actelion | NULL | Completed | 18 Years | 75 Years | All | 108 | Phase 4 | United States;Austria;France;Germany;Ireland;Norway;Portugal;Sweden;Switzerland;United Kingdom |
| 300 | EUCTR2017-000216-42-SE (EUCTR) | 24/10/2017 | 16/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 301 | NCT02932410 (ClinicalTrials.gov) | October 24, 2017 | 12/10/2016 | A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) | A Multicenter, Open-label, Randomized, Study With Single-arm Extension Period to Assess the Pharmacokinetics, Safety and Efficacy of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Macitentan;Other: Standard-of-care | Actelion | NULL | Recruiting | 1 Month | 17 Years | All | 300 | Phase 3 | United States;Australia;Austria;Brazil;Canada;China;Colombia;Finland;France;Hungary;Israel;Korea, Republic of;Malaysia;Mexico;Philippines;Poland;Portugal;Russian Federation;South Africa;Spain;Thailand;Ukraine;Vietnam;Argentina;Bulgaria |
| 302 | NCT03315507 (ClinicalTrials.gov) | October 20, 2017 | 2/10/2017 | A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAH | An Open-Label, Dose Titration Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046, A Sustained-Release Analogue of Vasoactive Intestinal Peptide, In Adult Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: PB1046 Subcutaneous Injection | PhaseBio Pharmaceuticals Inc. | NULL | Completed | 18 Years | N/A | All | 3 | Phase 1 | United States |
| 303 | EUCTR2016-001411-20-DE (EUCTR) | 17/10/2017 | 07/08/2017 | Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patients | Long-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QCC374 0.015 mg INN or Proposed INN: TBD Product Code: QCC374 0.06 mg INN or Proposed INN: TBD | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 38 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Germany;United Kingdom;Korea, Republic of | ||
| 304 | NCT03270332 (ClinicalTrials.gov) | October 5, 2017 | 30/8/2017 | Effect of Inhaled Albuterol in Pulmonary Hypertension | Effect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept Study | Pulmonary Hypertension | Drug: Albuterol;Drug: Placebo | University of Miami | NULL | Completed | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 305 | NCT03145298 (ClinicalTrials.gov) | October 1, 2017 | 2/5/2017 | ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApy | A Phase I Study of the Safety and Feasibility of Central Intravenous Delivery of Allogeneic Human Cardiosphere-Derived Stem Cells in Patients With Pulmonary Arterial Hypertension ALPHA Trial | Pulmonary Arterial Hypertension (PAH) | Biological: Allogeneic Human Cardiosphere-Derived Stem Cells;Biological: Placebo | Cedars-Sinai Medical Center | California Institute for Regenerative Medicine (CIRM) | Active, not recruiting | 18 Years | 75 Years | All | 26 | Phase 1 | United States |
| 306 | NCT02999906 (ClinicalTrials.gov) | October 2017 | 19/12/2016 | Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Oral Treprostinil;Drug: Placebo | United Therapeutics | NULL | Withdrawn | 18 Years | 79 Years | All | 0 | Phase 3 | NULL |
| 307 | NCT03001414 (ClinicalTrials.gov) | September 28, 2017 | 15/12/2016 | Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCs | A Multicentre, Late Phase Clinical Trial to Establish the Efficacy and Safety of Repeat Dosing of Autologous Endothelial Progenitor Cells (EPCs) Transfected With Human Endothelial NO-synthase (eNOS) in Patients With Pulmonary Arterial Hypertension (PAH) on Top of Conventional Treatments | Hypertension,Pulmonary | Biological: Placebo followed by Autologous EPCs transfected with human eNOS;Biological: Autologous EPCs transfected with human eNOS followed by Placebo;Biological: Autologous EPCs transfected with human eNOS | Northern Therapeutics | Ottawa Hospital Research Institute | Active, not recruiting | 18 Years | 80 Years | All | 12 | Phase 2/Phase 3 | Canada |
| 308 | NCT02927366 (ClinicalTrials.gov) | September 19, 2017 | 5/10/2016 | Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH Patients | A Randomized, Parallel-group, Placebo-controlled Subject and Investigator Blinded Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of QCC374 in the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: QCC374;Drug: Placebo Matching | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 8 | Phase 2 | United States;Germany;Korea, Republic of;United Kingdom;Taiwan |
| 309 | EUCTR2017-000216-42-IE (EUCTR) | 12/09/2017 | 05/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 3b study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 310 | NCT03273387 (ClinicalTrials.gov) | September 10, 2017 | 3/9/2017 | The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension | The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension Patients in National Cardiovascular Center Harapan Kita Hospital Indonesia | Precapillary Pulmonary Hypertension | Drug: Trimetazidine;Drug: Placebo oral capsule | Indonesia University | NULL | Completed | 18 Years | 65 Years | All | 26 | Phase 2/Phase 3 | Indonesia |
| 311 | EUCTR2017-000212-41-DE (EUCTR) | 01/09/2017 | 27/06/2017 | Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH) | An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GSK2586881 Product Code: GSK2586881 INN or Proposed INN: GSK2586881 Other descriptive name: Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Germany;Spain | ||
| 312 | EUCTR2017-000216-42-AT (EUCTR) | 29/08/2017 | 09/06/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | ||
| 313 | EUCTR2015-005223-90-HR (EUCTR) | 23/08/2017 | 12/09/2017 | This is a multicenter, double-blind, randomized, placebo-controlled,parallel-group study to investigate the efficacy, tolerability and safety ofpulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longerfor 18 weeks in symptomatic subjects with pulmonary arterialhypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED,CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 314 | EUCTR2017-000212-41-ES (EUCTR) | 10/08/2017 | 22/06/2017 | Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH). | An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension. - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GSK2586881 Product Code: GSK2586881 INN or Proposed INN: GSK2586881 Other descriptive name: Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01 | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Germany | ||
| 315 | EUCTR2016-001412-38-DE (EUCTR) | 27/07/2017 | 03/04/2017 | Safety, pharmacokinetics and efficacy study of QCC374 in PAH patients | A randomized, parallel-group, placebo-controlled subject and investigator blinded study to assess the safety, tolerability, pharmacokinetics and efficacy of QCC374 in the treatment of pulmonary arterial hypertension | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QCC374 0.015 mg INN or Proposed INN: TBD Product Code: QCC374 0.06 mg INN or Proposed INN: TBD | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | United States;Taiwan;Germany;United Kingdom;Korea, Republic of | ||
| 316 | NCT03045029 (ClinicalTrials.gov) | July 18, 2017 | 2/2/2017 | ADAPT - A Patient Registry of the Real-world Use of Orenitram® | ADAPT - A Patient Registry of the Real-world Use of Orenitram® | Pulmonary Arterial Hypertension | Drug: Oral treprostinil | United Therapeutics | NULL | Active, not recruiting | 18 Years | N/A | All | 300 | United States | |
| 317 | EUCTR2016-001062-28-ES (EUCTR) | 13/07/2017 | 13/01/2017 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Vietnam;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of | ||
| 318 | EUCTR2017-000216-42-GB (EUCTR) | 11/07/2017 | 05/05/2017 | Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;Switzerland;United Kingdom;Sweden | ||
| 319 | NCT02800941 (ClinicalTrials.gov) | July 5, 2017 | 10/6/2016 | Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension | Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension : HEMA-HTP Multicentric Study. | Pulmonary Arterial Hypertension | Drug: Oral anticoagulant treatment | Centre Hospitalier Universitaire de Saint Etienne | NULL | Recruiting | 18 Years | N/A | All | 203 | France | |
| 320 | JPRN-UMIN000027284 | 2017/07/01 | 01/07/2017 | The effect of iloprost on pulmonary hypertension and exercuse capacity | The effect of iloprost on pulmonary hypertension and exercuse capacity - Iloprost for Pulmonary Hypertension | Pulmonary arterial hypertension | inhale of iloprost | The University of Tokushima Graduate School of Health Biosciences | NULL | Pending | 20years-old | 90years-old | Male and Female | 20 | Not selected | Japan |
| 321 | EUCTR2014-003952-29-BE (EUCTR) | 07/06/2017 | 03/01/2017 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 322 | NCT02882126 (ClinicalTrials.gov) | June 2017 | 24/8/2016 | An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension | An Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003 | Pulmonary Arterial Hypertension | Drug: Subcutaneous Treprostinil | United Therapeutics | CVie Therapeutics Co. Ltd. | Withdrawn | 18 Years | N/A | All | 0 | Phase 4 | China |
| 323 | EUCTR2016-004035-21-DE (EUCTR) | 23/05/2017 | 14/02/2017 | A study to evaluate whether it is safe for patients with pulmonary arterial hypertension to temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein (intravenous selexipag) | A multicenter, open-label, single-sequence cross-over study to assess safety, tolerability, and pharmacokinetics of intravenous selexipag in subjects with stable pulmonary arterial hypertension switching from an oral stable dose of selexipag | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Germany | ||
| 324 | EUCTR2016-001062-28-PT (EUCTR) | 15/05/2017 | 23/12/2016 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Philippines;Finland;Thailand;Spain;Ukraine;Austria;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Viet Nam;Australia;South Africa;China;Korea, Republic of | ||
| 325 | NCT03401476 (ClinicalTrials.gov) | May 8, 2017 | 30/4/2017 | Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension | Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Morphine Sulfate | John Granton | NULL | Unknown status | 18 Years | N/A | All | 15 | Phase 2 | Canada |
| 326 | NCT03365479 (ClinicalTrials.gov) | May 1, 2017 | 27/11/2017 | Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension | Acute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension | Pulmonary Hypertension;Pulmonary Arterial Hypertension | Drug: Iloprost | University of Giessen | NULL | Completed | 18 Years | N/A | All | 30 | N/A | Germany |
| 327 | NCT03016468 (ClinicalTrials.gov) | May 2017 | 6/1/2017 | Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH | A Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Parenteral Remodulin (treprostinil) injection;Drug: Oral Treprostinil | United Therapeutics | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | NULL |
| 328 | NCT02911844 (ClinicalTrials.gov) | April 10, 2017 | 19/9/2016 | Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension | Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Fulvestrant | University of Pennsylvania | NULL | Completed | 18 Years | N/A | Female | 5 | Phase 2 | United States |
| 329 | NCT03431649 (ClinicalTrials.gov) | April 1, 2017 | 29/7/2017 | Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children | Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect | Pediatric Pulmonary Hypertension | Drug: Beraprost Sodium;Drug: Sildenafil Citrate | Dr. Soetomo General Hospital | NULL | Completed | 1 Year | 17 Years | All | 40 | Phase 4 | Indonesia |
| 330 | NCT02587325 (ClinicalTrials.gov) | April 1, 2017 | 23/10/2015 | Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension | A Phase 1/1b Clinical Trial of ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: nab-sirolimus (also known as ABI-009, nab-rapamycin, albumin-bound rapamycin) | Aadi Bioscience, Inc. | NULL | Completed | 18 Years | N/A | All | 15 | Phase 1 | United States |
| 331 | NCT04991181 (ClinicalTrials.gov) | March 31, 2017 | 28/7/2021 | Absorption, Distribution, Metabolism and Excretion of BIA 5-1058 | An Open-label Study to Assess the Absorption, Distribution, Metabolism and Excretion, Including the Mass Balance, of [14C] Labeled BIA 5-1058 and Metabolites Following a Single Oral Dose Administration in Healthy Male Subjects | Pulmonary Arterial Hypertension | Drug: 400 mg BIA 5-1058 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 65 Years | Male | 15 | Phase 1 | Netherlands |
| 332 | EUCTR2016-001067-36-DE (EUCTR) | 22/03/2017 | 10/11/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 333 | EUCTR2016-001067-36-DK (EUCTR) | 15/03/2017 | 23/12/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 334 | JPRN-JapicCTI-132356 | 08/3/2017 | 22/11/2013 | H6D-MC-LVHV | A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Intervention name : Tadalafil INN of the intervention : - Dosage And administration of the intervention : Tadalafil doses may range from 5 mg to 40 mg depending on body weight cohorts. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Tadalafil doses may range from 5 mg to 40 mg depending on body weight cohorts. | Eli Lilly Japan K.K. | NULL | complete | BOTH | 5 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe | ||
| 335 | EUCTR2016-001067-36-GR (EUCTR) | 02/03/2017 | 17/01/2017 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | Switzerland;Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 336 | EUCTR2015-005223-90-AT (EUCTR) | 28/02/2017 | 16/01/2017 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 337 | EUCTR2016-001067-36-NL (EUCTR) | 23/02/2017 | 07/12/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 338 | EUCTR2016-001067-36-BE (EUCTR) | 20/02/2017 | 14/11/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 339 | EUCTR2016-001062-28-AT (EUCTR) | 07/02/2017 | 21/12/2016 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, study with single-arm extension period to assess the pharmacokinetics, safety and efficacy of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Viet Nam;Australia;South Africa;China;Korea, Republic of | ||
| 340 | NCT02893995 (ClinicalTrials.gov) | February 2017 | 24/8/2016 | Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial Hypertension | A 16-Week, Open-Label, Multi-Center, Parallel, Randomized Controlled Study to Compare the Safety, Tolerability, Pharmacokinetics and Efficacy of Slow and Rapid Dose Titration Regimens of Subcutaneous Remodulin Therapy in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Slow Dose Titration Group of Subcutaneous Treprostinil;Drug: Rapid Dose Titration Group of Subcutaneous Treprostinil | United Therapeutics | CVie Therapeutics Co. Ltd. | Withdrawn | 18 Years | N/A | All | 0 | Phase 4 | China |
| 341 | EUCTR2016-001062-28-HU (EUCTR) | 25/01/2017 | 15/12/2016 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Vietnam;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of | ||
| 342 | EUCTR2016-001067-36-CZ (EUCTR) | 19/01/2017 | 13/10/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Revatio Product Name: Revatio 20 mg film-coated tablets INN or Proposed INN: SILDENAF | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 218 | Phase 4 | Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 343 | EUCTR2015-005223-90-NL (EUCTR) | 17/01/2017 | 05/09/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 344 | EUCTR2014-000667-40-SK (EUCTR) | 17/01/2017 | 01/04/2016 | A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension. | A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria | ||
| 345 | NCT02891850 (ClinicalTrials.gov) | January 11, 2017 | 26/8/2016 | Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy | A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal | Pulmonary Arterial Hypertension | Drug: Adempas (Riociguat, BAY63-2521);Drug: Sildenafil;Drug: Tadalafil | Bayer | NULL | Completed | 18 Years | 75 Years | All | 225 | Phase 4 | United States;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;Australia;Switzerland |
| 346 | JPRN-UMIN000025176 | 2017/01/01 | 15/12/2016 | Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension. | Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension. - Efficacy, tolerability, and safety of transition from beraprost to selexipag | Pulmonary arterial hypertension | Medicine transition from beraprost to selexipag In accordance with the Japanese package insert (http://www.info.pmda.go.jp/go/pack/2190037F1020_1_02/), selexipag is initiated at a dose of 0.2mg twice daily and is increased in twice-daily increments of 0.2mg until unmanageable adverse effects associated with prostacyclin use, such as headache or jaw pain, developed. The maximum dose allowed is 1.6mg twice daily. | Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 33 | Not selected | Japan |
| 347 | EUCTR2016-001067-36-PT (EUCTR) | 29/12/2016 | 13/09/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Tadalafil INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 348 | EUCTR2016-001067-36-GB (EUCTR) | 21/12/2016 | 24/10/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Tadalafil INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 349 | EUCTR2015-005223-90-DE (EUCTR) | 16/12/2016 | 09/05/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part2) which provides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Colombia;Hungary;United States;Ukraine;United Kingdom;Portugal;Spain;Canada;Czech Republic;Netherlands;Austria;Belgium;Korea, Republic of;Italy;Israel;Australia;France;Serbia;Germany;Croatia | ||
| 350 | EUCTR2016-001067-36-IT (EUCTR) | 12/12/2016 | 05/11/2020 | A study to find out whether some PAH patients may benefit by replacing their current hosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 1.0 INN or Proposed INN: Riociguat Other descriptive name: Riociguat Trade Name: ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 1.5 mg INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: ADEMPAS - 0,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 0.5 mg compressa rivestita con film INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 2.0 mg INN or Proposed INN: Riociguat Other descriptive name: Riociguat Trade Name: ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 2.5 mg INN or Proposed INN: Riociguat | BAYER AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Germany;Japan;New Zealand;Portugal;United States;Taiwan;Greece;Spain;Italy;Switzerland | ||
| 351 | EUCTR2010-024585-22-DE (EUCTR) | 01/12/2016 | 17/08/2016 | What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? | What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? - Ferinject® for iron deficiency in IPAH patients | Idiopathic or familial pulmonary arterial hypertension MedDRA version: 19.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Ferinject Product Name: Ferinject INN or Proposed INN: FERRIC CARBOXYMALTOSE | Imperial College Academic Healthsciences Centre | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Germany;United Kingdom | ||
| 352 | NCT02981082 (ClinicalTrials.gov) | December 2016 | 30/11/2016 | Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension | A Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress. | Systemic Sclerosis;Pulmonary; Hypertension | Drug: Dimethyl Fumarate (DMF);Drug: Placebo Oral Tablet | Robert Lafyatis | Biogen | Terminated | 18 Years | 80 Years | All | 6 | Phase 1 | United States |
| 353 | NCT03053739 (ClinicalTrials.gov) | December 2016 | 29/12/2016 | To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis | Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis | Associated Pulmonary Arterial Hypertension | Drug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and Placebo | Postgraduate Institute of Medical Education and Research | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | India |
| 354 | NCT02736149 (ClinicalTrials.gov) | December 2016 | 4/4/2016 | Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) | A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety and Efficacy of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) | Pulmonary Arterial Hypertension | Drug: ubenimex | Eiger BioPharmaceuticals | NULL | Terminated | 18 Years | 75 Years | All | 51 | Phase 2 | United States;Canada |
| 355 | EUCTR2015-005223-90-PT (EUCTR) | 30/11/2016 | 09/05/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 16 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 | Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 356 | EUCTR2016-003495-53-NL (EUCTR) | 29/11/2016 | 15/12/2016 | Study on the effect of the drug selexipag in adult patients with elevated pressure in the pulmonary arteries due to a cardiac birth defect | Prostacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease - SELECT trial | Pulmonary arterial hypertension related to congenital heart disease.;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Selexipag Product Name: Selexipag | Academic Medical Center - Cardiology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 357 | EUCTR2016-001067-36-ES (EUCTR) | 21/11/2016 | 09/09/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 358 | EUCTR2016-001067-36-AT (EUCTR) | 10/11/2016 | 20/09/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Revatio Product Name: Revatio 20 mg film-coated tablets INN or Proposed INN: SILDENAF | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 218 | Phase 4 | Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 359 | ChiCTR-DDD-16009406 | 2016-11-01 | 2016-10-14 | System Construction of Precious Diagnosis and Evaluation for Pulmonary Arterial Hpyertension | System Construction of Precious Diagnosis and Evaluation for Pulmonary Arterial Hpyertension | Pulmonary arterial hypertension | Gold Standard:;Index test:; | Shanghai Pulmonary Hospital | NULL | Pending | Both | Target condition:0;Difficult condition:0 | China | |||
| 360 | EUCTR2016-000196-24-GB (EUCTR) | 18/10/2016 | 28/11/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 361 | EUCTR2016-000196-24-BE (EUCTR) | 17/10/2016 | 11/07/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 362 | EUCTR2016-000196-24-NL (EUCTR) | 10/10/2016 | 13/07/2016 | BADOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 363 | NCT02657356 (ClinicalTrials.gov) | October 4, 2016 | 13/1/2016 | Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST | A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Drug: Placebo capsules;Drug: Bardoxolone methyl capsules | Reata Pharmaceuticals, Inc. | NULL | Terminated | 18 Years | 75 Years | All | 202 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Germany;Israel;Japan;Mexico;Netherlands;Philippines;Spain;United Kingdom;Chile;Czech Republic |
| 364 | EUCTR2015-005223-90-CZ (EUCTR) | 27/09/2016 | 22/06/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 365 | EUCTR2015-005223-90-IT (EUCTR) | 15/09/2016 | 22/06/2021 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks. | A phase 3, placebo controlled, double-blind, randomized, clinical study to determine efficacy, safety and tolerability of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH): INOvation-1 (Part 1 and Part 2) - Efficacy and safety of iNO in Pulmonary Arterial Hypertension, v1.0 | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: Ossido Nitrico Other descriptive name: inhaled NO with pulsed delivery | BELLEROPHON PULSE TECHNOLOGIES LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Portugal;Serbia;United States;Czechia;Spain;Ukraine;Austria;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 366 | NCT02826252 (ClinicalTrials.gov) | September 15, 2016 | 5/7/2016 | Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20) | VENTASWITCH, Examination of Ventavis® (Iloprost) Inhalation Behavior Using the I-Neb® AAD® System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20) | Hypertension, Pulmonary | Drug: Iloprost,(Ventavis, BAYQ6256);Device: I-Neb AAD system | Bayer | NULL | Completed | 18 Years | N/A | All | 64 | N/A | Germany |
| 367 | JPRN-UMIN000025158 | 2016/09/01 | 07/12/2016 | A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension - A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Drug: Bardoxolone Methyl Bardoxolone methyl dose escalated to a maximum of 10 mg. Dosing period is up to 6 months. Drug: Placebo Oral Capsule Capsule containing an inert placebo is administrated up to 6 months. | Reata Pharmaceuticals, Inc. | NULL | Complete: follow-up complete | 18years-old | 75years-old | Male and Female | 20 | Phase 3 | Japan,North America,South America,Australia,Europe |
| 368 | EUCTR2016-000196-24-CZ (EUCTR) | 30/08/2016 | 18/07/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 369 | EUCTR2015-003438-28-DK (EUCTR) | 17/08/2016 | 30/05/2016 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden | ||
| 370 | EUCTR2016-000196-24-DE (EUCTR) | 11/08/2016 | 27/06/2016 | BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;Netherlands;Japan | ||
| 371 | NCT02825160 (ClinicalTrials.gov) | August 1, 2016 | 15/6/2016 | Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH) | Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Ventavis (Iloprost, BAYQ6256) | Bayer | NULL | Recruiting | N/A | N/A | All | 270 | Japan | |
| 372 | EUCTR2014-003952-29-PL (EUCTR) | 28/07/2016 | 13/04/2016 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| 373 | EUCTR2015-005223-90-GB (EUCTR) | 12/07/2016 | 11/04/2016 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | United States;Serbia;Portugal;Spain;Ukraine;Austria;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 374 | EUCTR2016-000196-24-ES (EUCTR) | 04/07/2016 | 01/06/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 375 | NCT02782052 (ClinicalTrials.gov) | July 2016 | 17/5/2016 | Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial Hypertension | Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Nebulized ipratropium bromide;Drug: Nebulized combination ipratropium bromide with salbutamol;Drug: Nebulized Placebo | Assistance Publique - Hôpitaux de Paris | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | NULL |
| 376 | NCT02899533 (ClinicalTrials.gov) | July 2016 | 2/8/2016 | [18F]FES PET/CT in PAH | [18F]Fluoroestradiol (FES) PET/CT Imaging To Evaluate In Vivo ER In Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: [18F] FES | University of Pennsylvania | NULL | Terminated | 18 Years | N/A | Female | 5 | United States | |
| 377 | EUCTR2015-003438-28-FR (EUCTR) | 20/06/2016 | 21/04/2016 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON | Pulmonary arterial hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 378 | NCT02759419 (ClinicalTrials.gov) | June 16, 2016 | 29/4/2016 | A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension. | An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial | Hypertension, Pulmonary | Drug: Adempas (Riociguat, BAY63-2521) | Bayer | NULL | Recruiting | 18 Years | N/A | All | 25 | Phase 4 | France;Italy;Korea, Republic of;Poland;Thailand |
| 379 | NCT02885012 (ClinicalTrials.gov) | June 2016 | 3/5/2016 | Crossover Study From Macitentan or Bosentan Over to Ambrisentan | A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Ambrisentan | Medical University of South Carolina | Ochsner Health System | Terminated | 18 Years | 80 Years | All | 3 | Phase 4 | United States |
| 380 | EUCTR2014-003042-27-SK (EUCTR) | 26/05/2016 | 01/04/2016 | Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003) | An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria | ||
| 381 | NCT02558231 (ClinicalTrials.gov) | May 1, 2016 | 22/9/2015 | The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension | The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study | Pulmonary Arterial Hypertension | Drug: Macitentan;Drug: Tadalafil;Drug: Selexipag | Actelion | NULL | Completed | 18 Years | 75 Years | All | 247 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Norway |
| 382 | NCT02705807 (ClinicalTrials.gov) | May 2016 | 25/2/2016 | Evaluation of a New Thermostable Formulation of FLOLAN in Japanese Subjects | An Open Label, Single-arm Study Evaluating a New Thermostable Formulation of FLOLAN™ in Japanese Subjects With Pulmonary Arterial Hypertension (PAH) | Cardiovascular Disease | Drug: FLOLAN injection with currently marketed diluent;Drug: FLOLAN injection with reformulated diluent | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 4 | Japan |
| 383 | NCT03809156 (ClinicalTrials.gov) | April 26, 2016 | 9/1/2019 | Upfront Combination Pulmonary Arterial Hypertension Therapy | Upfront Riociguat and Ambrisentan Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot Study | Pulmonary Hypertension | Drug: Riociguat Oral Product | University of Calgary | Bayer | Recruiting | 18 Years | N/A | All | 20 | Phase 4 | Canada |
| 384 | EUCTR2014-003952-29-DE (EUCTR) | 21/04/2016 | 10/08/2015 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Belgium;Romania;Germany;Japan | ||
| 385 | EUCTR2015-003438-28-NO (EUCTR) | 11/04/2016 | 09/03/2016 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON | Pulmonary arterial hypertension (PAH) MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 386 | EUCTR2014-003952-29-ES (EUCTR) | 01/04/2016 | 17/02/2016 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer Healthcare AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United Kingdom;France;Hungary;Belgium;Poland;Spain;Turkey;Netherlands;Germany;Japan;Italy | ||
| 387 | NCT03057028 (ClinicalTrials.gov) | April 2016 | 4/5/2016 | Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension | Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Anakinra | Virginia Commonwealth University | NULL | Completed | 18 Years | N/A | All | 7 | Phase 1 | United States |
| 388 | NCT02734953 (ClinicalTrials.gov) | April 2016 | 26/3/2016 | Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH | Effects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Nitric Oxide | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | NULL | Completed | 18 Years | 80 Years | All | 10 | Phase 2 | United States |
| 389 | NCT02725372 (ClinicalTrials.gov) | April 2016 | 19/1/2016 | Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH | A Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects With PAH (Part 1 and Part 2) | Pulmonary Arterial Hypertension | Drug: Inhaled Nitric Oxide 75 mcg/kg IBW/hr;Drug: Placebo | Bellerophon Pulse Technologies | Worldwide Clinical Trials | Terminated | 18 Years | 85 Years | All | 207 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czechia;France;Germany;Israel;Italy;Netherlands;Portugal;Serbia;Spain;Ukraine;United Kingdom |
| 390 | NCT02664558 (ClinicalTrials.gov) | April 2016 | 21/1/2016 | A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) | A Phase 2, Randomized, Double-BLInd, Placebo- Controlled Study of UBEnimex in Patients With Pulmonary ARTerial HYpertension (WHO Group 1) (LIBERTY) | Pulmonary Arterial Hypertension | Drug: ubenimex;Other: placebo | Eiger BioPharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 61 | Phase 2 | United States;Canada |
| 391 | EUCTR2015-003438-28-DE (EUCTR) | 04/03/2016 | 19/01/2016 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 392 | EUCTR2015-003438-28-BE (EUCTR) | 03/03/2016 | 09/06/2020 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 393 | NCT02652429 (ClinicalTrials.gov) | March 2016 | 17/12/2015 | Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH | An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH for Subjects in the PULSE-PAH-006 and PULSE-PAH-004 Studies Who Continue to Need iNO Therapy | Pulmonary Arterial Hypertension | Drug: Inhaled Nitric Oxide | Bellerophon Pulse Technologies | NULL | Active, not recruiting | N/A | N/A | All | 22 | Phase 3 | United States;Canada |
| 394 | EUCTR2012-000098-21-PL (EUCTR) | 27/02/2016 | 20/01/2016 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 |