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 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 | |
| 16 | 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 |
| 17 | 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 |
| 18 | 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 |
| 19 | 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 |
| 20 | 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 |
| 21 | 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 |
| 22 | 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 |
| 23 | 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 |
| 24 | 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 |
| 25 | 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 |
| 26 | 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 |
| 27 | 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 |
| 28 | 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 |
| 29 | 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 |
| 30 | 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 | ||
| 31 | 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 |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 |
| 38 | 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 |
| 39 | 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 | |
| 40 | 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 | ||
| 41 | 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 | ||
| 42 | 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 | ||
| 43 | 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 | |
| 44 | 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 | ||
| 45 | 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 | ||
| 46 | 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 |
| 47 | 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 | ||
| 48 | 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 |
| 49 | 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 |
| 50 | 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 |
| 51 | 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 |
| 52 | 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 |
| 53 | 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 |
| 54 | 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 |
| 55 | 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 |
| 56 | 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 |
| 57 | 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 |
| 58 | 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 |
| 59 | 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 |
| 60 | 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 | |
| 61 | 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 |
| 62 | 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 |
| 63 | 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 |
| 64 | 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 | |
| 65 | 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 |
| 66 | 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 |
| 67 | 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 | |
| 68 | 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 | |
| 69 | 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 |
| 70 | 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 |
| 71 | 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 | ||
| 72 | 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 |
| 73 | 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 |
| 74 | 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 |
| 75 | 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 |
| 76 | 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 |
| 77 | 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 |
| 78 | 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 |
| 79 | 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 |
| 80 | 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 |
| 81 | 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 |
| 82 | 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 |
| 83 | 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 |
| 84 | 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 |
| 85 | 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 | |
| 86 | 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 |
| 87 | 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 |
| 88 | 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 |
| 89 | 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 |
| 90 | 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 |
| 91 | 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 |
| 92 | 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 |
| 93 | 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 |
| 94 | 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 |
| 95 | 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 |
| 96 | 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 |
| 97 | 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 |
| 98 | 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 |
| 99 | 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 |
| 100 | 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 | ||
| 101 | 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 |
| 102 | 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 |
| 103 | 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 |
| 104 | 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 |
| 105 | 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 |
| 106 | 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 |
| 107 | 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 |
| 108 | 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 |
| 109 | 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 |
| 110 | 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 |
| 111 | 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 |
| 112 | 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 |
| 113 | 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 |
| 114 | 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 |
| 115 | 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 |
| 116 | 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 | |
| 117 | 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 |
| 118 | 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 |
| 119 | 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 |
| 120 | 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 |
| 121 | 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 | |
| 122 | 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 |
| 123 | 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 |
| 124 | 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 |
| 125 | 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 |
| 126 | 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 |
| 127 | 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 |
| 128 | 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 |
| 129 | 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 |
| 130 | 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 |
| 131 | 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 | ||
| 132 | 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 | |
| 133 | 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 | |
| 134 | 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 |
| 135 | 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 |
| 136 | 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 |
| 137 | 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 |
| 138 | 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 |
| 139 | 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 |
| 140 | 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 | ||
| 141 | 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 |
| 142 | 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 | ||
| 143 | 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 |
| 144 | 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 |
| 145 | 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 | ||
| 146 | 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 |
| 147 | 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 |
| 148 | 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 |
| 149 | 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 |
| 150 | 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 | ||
| 151 | 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 | ||
| 152 | 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 |
| 153 | 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 | |
| 154 | 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 | ||
| 155 | 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 |
| 156 | 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 |
| 157 | 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 |
| 158 | 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 |
| 159 | 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 |
| 160 | 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 |
| 161 | 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 |
| 162 | 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 |
| 163 | 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 |
| 164 | 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 |
| 165 | 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 |
| 166 | NCT02507011 (ClinicalTrials.gov) | January 31, 2016 | 22/7/2015 | Beta-blockers in Pulmonary Arterial Hypertension | Beta-blockers in Pulmonary Arterial Hypertension - A Phase 2 Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy, and Safety of Carvedilol for Right Ventricular Dysfunction in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Carvedilol;Drug: Placebo | University of Minnesota | NULL | Terminated | 18 Years | N/A | All | 2 | Phase 2 | United States |
| 167 | NCT02676947 (ClinicalTrials.gov) | January 2016 | 21/12/2015 | A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension | A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Tocilizumab | Papworth Hospital NHS Foundation Trust | Roche Pharma AG;National Institute for Health Research, United Kingdom | Completed | 18 Years | 70 Years | All | 29 | Phase 2 | United Kingdom |
| 168 | NCT02551653 (ClinicalTrials.gov) | November 17, 2015 | 14/9/2015 | Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients | A Microdose Study to Evaluate the Biodistribution of [11C]-GSK2256098 in the Lungs and Heart of Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients Using Positron Emission Tomography (PET) | Hypertension, Pulmonary | Drug: [11C]-GSK2256098 500 MBq | GlaxoSmithKline | NULL | Completed | 40 Years | 70 Years | All | 10 | Phase 1 | United Kingdom |
| 169 | NCT02471183 (ClinicalTrials.gov) | November 4, 2015 | 11/6/2015 | Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension | Multicenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Selexipag | Actelion | NULL | Completed | 18 Years | 75 Years | All | 30 | Phase 3 | United States |
| 170 | NCT02562235 (ClinicalTrials.gov) | October 29, 2015 | 28/9/2015 | Riociguat in Children With Pulmonary Arterial Hypertension (PAH) | 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) | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | Merck Sharp & Dohme LLC | Active, not recruiting | 6 Years | 17 Years | All | 24 | Phase 3 | Colombia;Germany;Hungary;Italy;Japan;Mexico;Poland;Taiwan;Turkey;Belgium;Brazil;France;Netherlands;Romania;Spain;United Kingdom;United States |
| 171 | EUCTR2015-000709-38-AT (EUCTR) | 20/10/2015 | 28/07/2015 | Effects of the drug Benzbromaron on the pulmonary vessels | Acute Effects of Benzbromaron on the pulmonary circulation | 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] - Cardiovascular Diseases [C14] | Trade Name: Benzbromaron AL Product Name: Benzbromaron INN or Proposed INN: BENZBROMARONE | Medical University of Graz | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Austria | |||
| 172 | NCT04991194 (ClinicalTrials.gov) | October 12, 2015 | 28/7/2021 | Effect of Age-gender on the Pharmacokinetic and Pharmacodynamic Profiles of BIA 5 1058 | Effect of Age-gender on the Pharmacokinetic and Pharmacodynamic Profiles of BIA 5 1058. An Open-label, Parallel Group, Multiple Dose 10-day Study. | Pulmonary Arterial Hypertension | Drug: BIA 5-1058 | Bial - Portela C S.A. | NULL | Terminated | 18 Years | N/A | All | 61 | Phase 1 | NULL |
| 173 | NCT02545465 (ClinicalTrials.gov) | September 15, 2015 | 8/9/2015 | A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice | Retrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to Adempas | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | NULL | Completed | N/A | N/A | All | 125 | N/A | Belgium;Canada;Colombia;Germany;Japan;Sweden;Turkey;Denmark;United Kingdom |
| 174 | NCT02968901 (ClinicalTrials.gov) | September 1, 2015 | 14/11/2016 | Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA) | Prospective, Multicenter, Open-label Study Evaluating the Effects of First-line Oral Combination Therapy of Macitentan and Tadalafil in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (OPTIMA). | Pulmonary Arterial Hypertension | Drug: macitentan;Drug: tadalafil | Actelion | NULL | Terminated | 18 Years | 75 Years | All | 46 | Phase 4 | France |
| 175 | NCT02253394 (ClinicalTrials.gov) | September 2015 | 17/9/2014 | The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study | The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study) | Pulmonary Arterial Hypertension | Drug: Ambrisentan plus Spironolactone;Drug: Ambrisentan plus Placebo | Brigham and Women's Hospital | Gilead Sciences | Terminated | 18 Years | N/A | All | 2 | Phase 4 | United States |
| 176 | NCT04991155 (ClinicalTrials.gov) | July 20, 2015 | 28/7/2021 | Effect of Food on BIA 5-1058 | Effect of Food on BIA 5-1058 Bioavailability in Healthy Subjects | Pulmonary Arterial Hypertension | Drug: BIA 5-1058 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 57 | Phase 1 | NULL |
| 177 | NCT02279745 (ClinicalTrials.gov) | July 2015 | 25/10/2014 | Long Term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension | An Open-Label Extension Study of Ralinepag in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Ralinepag | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 60 | Phase 2 | United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Slovakia;Spain |
| 178 | NCT02428985 (ClinicalTrials.gov) | June 29, 2015 | 21/4/2015 | Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH) | Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Riociguat (ADEMPAS, BAY63-2521) | Bayer | NULL | Recruiting | N/A | N/A | All | 600 | Japan | |
| 179 | NCT02310672 (ClinicalTrials.gov) | June 1, 2015 | 4/12/2014 | REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension | A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Completed | 18 Years | 64 Years | All | 89 | Phase 4 | United States;Australia;France;Germany;Hong Kong;Israel;Italy;Malaysia;Netherlands;Russian Federation;Singapore;United Kingdom |
| 180 | NCT02276872 (ClinicalTrials.gov) | December 18, 2014 | 21/10/2014 | Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years | A Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial Hypertension | PAH | Drug: oral treprostinil | United Therapeutics | NULL | Completed | 7 Years | 17 Years | All | 32 | Phase 2 | United States |
| 181 | NCT02279160 (ClinicalTrials.gov) | December 2014 | 25/10/2014 | Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension | A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of Ralinepag, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: APD811;Drug: Placebo | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 61 | Phase 2 | United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Spain;Czech Republic |
| 182 | NCT02234141 (ClinicalTrials.gov) | November 2014 | 2/9/2014 | Selonsertib in Adults With Pulmonary Arterial Hypertension | A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Placebo;Drug: Selonsertib | Gilead Sciences | NULL | Completed | 18 Years | 75 Years | All | 151 | Phase 2 | United States;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 183 | NCT02191137 (ClinicalTrials.gov) | September 23, 2014 | 27/6/2014 | Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION) | A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | NULL | Completed | 18 Years | 80 Years | All | 75 | Phase 4 | United States;Puerto Rico |
| 184 | NCT02060487 (ClinicalTrials.gov) | September 22, 2014 | 29/1/2014 | Effects of Oral Sildenafil on Mortality in Adults With PAH | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension | Drug: sildenafil citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Terminated | 18 Years | 74 Years | All | 385 | Phase 4 | United States;Australia;Belgium;Bosnia and Herzegovina;Croatia;Czechia;Germany;Greece;Hong Kong;Israel;Latvia;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Singapore;South Africa;Spain;Thailand;Turkey;Ukraine;Austria;Czech Republic;Netherlands;Portugal |
| 185 | NCT02290613 (ClinicalTrials.gov) | July 1, 2014 | 31/10/2014 | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITA | Systemic Sclerosis;Pulmonary Hypertension | Drug: Ambrisentan;Drug: Placebo | Heidelberg University | GlaxoSmithKline | Completed | 18 Years | N/A | All | 38 | Phase 2 | Germany |
| 186 | NCT02112487 (ClinicalTrials.gov) | June 23, 2014 | 8/4/2014 | Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH | An Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™ | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Completed | 18 Years | 80 Years | All | 88 | Phase 3 | France;Italy;Spain |
| 187 | NCT02108743 (ClinicalTrials.gov) | June 2014 | 7/4/2014 | Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension | Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension. | Drug: Albuterol.;Drug: Normal saline placebo | American Medical Association Foundation | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 2 | United States |
| 188 | NCT02036970 (ClinicalTrials.gov) | May 2014 | 13/1/2014 | Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT | A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Interstitial Pneumonia;Idiopathic Pulmonary Fibrosis;Sarcoidosis;Respiratory Bronchiolitis Associated Interstitial Lung Disease;Desquamative Interstitial Pneumonia;Cryptogenic Organizing Pneumonia;Acute Interstitial Pneumonitis;Idiopathic Lymphoid Interstitial Pneumonia;Idiopathic Pleuroparenchymal Fibroelastosis | Drug: Bardoxolone methyl;Drug: Placebo | Reata Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 75 Years | All | 166 | Phase 2 | United States;Germany;Spain;United Kingdom |
| 189 | NCT02120339 (ClinicalTrials.gov) | May 2014 | 17/4/2014 | Carvedilol PAH A Pilot Study of Efficacy and Safety | Beta Blockers in Pulmonary Arterial Hypertension (PAH) A Pilot Study of Efficacy and Safety | Pulmonary Hypertension;Cardiac MRI <40 | Drug: Carvedilol | University of Minnesota | NULL | Terminated | 18 Years | 99 Years | All | 5 | Phase 1 | United States |
| 190 | NCT02126943 (ClinicalTrials.gov) | April 30, 2014 | 29/4/2014 | OPsumit USers Registry | US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice | Pulmonary Arterial Hypertension | Drug: Opsumit (macitentan) | Actelion | NULL | Completed | N/A | N/A | All | 2686 | United States;Puerto Rico | |
| 191 | NCT02032836 (ClinicalTrials.gov) | March 10, 2014 | 9/1/2014 | Comparative PK PD Study in PAH Patients (Fox vs. I-Neb) | A Multi-center, Open-label, Randomized Cross-over Study to Compare the Acute Tolerability and Pharmacokinetics of BAYQ6256 (Iloprost; Ventavis) Inhalation Using the I-Neb Nebulizer and the FOX Nebulizer in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL);Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL) | Bayer | NULL | Completed | 18 Years | N/A | All | 27 | Phase 1/Phase 2 | Austria;Germany |
| 192 | NCT02081690 (ClinicalTrials.gov) | March 1, 2014 | 5/3/2014 | A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain | A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™ | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Terminated | 18 Years | 80 Years | All | 160 | Phase 3 | France;Italy;Spain |
| 193 | NCT02007629 (ClinicalTrials.gov) | February 18, 2014 | 6/12/2013 | Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor | An Open-label, International, Multicenter, Single-arm, Uncontrolled, Phase IIIb Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Demonstrate an Insufficient Response to Treatment With Phosphodiesterase-5 Inhibitors (PDE-5i) | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | NULL | Completed | 18 Years | 75 Years | All | 61 | Phase 3 | United States;Belgium;Canada;Czechia;France;Germany;Italy;Switzerland;United Kingdom;Czech Republic |
| 194 | NCT01824290 (ClinicalTrials.gov) | February 5, 2014 | 1/4/2013 | A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH) | A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Tadalafil;Drug: Placebo;Drug: ERA as specific PAH treatment | Eli Lilly and Company | NULL | Completed | 6 Months | 17 Years | All | 35 | Phase 3 | United States;Austria;Belgium;Brazil;France;Germany;Israel;Italy;Japan;Mexico;Netherlands;Poland;Spain;Turkey;Canada;Romania;Switzerland |
| 195 | NCT02042014 (ClinicalTrials.gov) | January 22, 2014 | 17/1/2014 | Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan | An Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 Treatment | Severe Pulmonary Arterial Hypertension | Drug: QTI571 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 8 | Phase 3 | Japan |
| 196 | NCT01712620 (ClinicalTrials.gov) | January 10, 2014 | 20/10/2012 | Spironolactone for Pulmonary Arterial Hypertension | A Pilot Study of the Effect of Spironolactone Therapy on Exercise Capacity and Endothelial Dysfunction in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Spironolactone;Drug: Placebo | National Institutes of Health Clinical Center (CC) | National Heart, Lung, and Blood Institute (NHLBI);National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);University of Pennsylvania;University of Maryland Medical Center;Medstar Health Research Institute;New England Medical Center, Tufts University School of Medicine | Recruiting | 18 Years | N/A | All | 70 | Phase 2 | United States |
| 197 | NCT01934647 (ClinicalTrials.gov) | November 22, 2013 | 30/8/2013 | Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003) | A Non-randomized, Single-Panel, Open-Label Trial to Study the Safety, Tolerability and Pharmacodynamics of MK-8892 Acute Dosing in Subjects With Moderate to Severe Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: MK-8892 | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | 70 Years | All | 7 | Phase 1 | Germany |
| 198 | NCT01926509 (ClinicalTrials.gov) | November 14, 2013 | 19/8/2013 | Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-005) | A 28-Day Multiple-Dose Titration Study to Assess the Effects of MK-8892 on Safety, Tolerability and Pharmacokinetics in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: MK-8892;Drug: Placebo for MK-8892 | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 70 Years | All | 23 | Phase 1 | Bulgaria;Germany;Moldova, Republic of |
| 199 | EUCTR2013-001100-10-ES (EUCTR) | 12/11/2013 | 12/11/2013 | This study is to allow continued access to QTI571 for patients whoreceived QTI571 for pulmonary arterial hypertension in one of thelong-term extension studies (A2301E1, A2102E1 and E2203) andhave been judged by the investigator to benefit from continuedQTI571 treatment. | An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in one of the extension studies and are judged by the investigator to benefit from continued QTI571 treatment | Pulmonary Arterial Hypertension MedDRA version: 16.1;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: GLIVEC 100 mg comprimidos recubiertos con película Product Name: Imatinib mesilate Product Code: QTI571 INN or Proposed INN: IMATINIB MESILATE | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 81 | United States;Spain;Australia;Switzerland | |||
| 200 | NCT02000856 (ClinicalTrials.gov) | November 2013 | 19/11/2013 | BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension | BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Dietary Supplement: Beetroot juice | Uppsala University | Karolinska Institutet | Completed | 18 Years | N/A | All | 15 | N/A | Sweden |
| 201 | NCT01966302 (ClinicalTrials.gov) | November 2013 | 15/10/2013 | Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH) | Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three Patients With Pulmonary Arterial Hypertension (PAH). | Pulmonary Arterial Hypertension | Drug: BPS-314d-MR | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Lung Biotechnology PBC | Completed | 18 Years | 75 Years | All | 1 | Phase 2 | United States |
| 202 | NCT03638908 (ClinicalTrials.gov) | November 2013 | 12/7/2018 | Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial | A Phase 2, Open-label, Clinical Trial of Fluoxetine, a Selective Serotonin Reuptake Inhibitor, in the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Fluoxetine | University of Texas Southwestern Medical Center | NULL | Completed | 16 Years | 80 Years | All | 8 | Phase 2 | United States |
| 203 | NCT01827059 (ClinicalTrials.gov) | October 2013 | 5/4/2013 | Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasE | A Randomized Placebo Controlled Trial to Analyze Changes in Pulmonary Arterial Pressures at Peak Exercise in Congenital Heart Disease Patients With Exercise-induced Pulmonary Arterial Hypertension Before and After Treatment With Bosentan, Compared to Placebo | Pulmonary Arterial Hypertension;Congenital Heart Disease | Drug: Bosentan;Drug: Placebo | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | NULL | Active, not recruiting | 18 Years | N/A | All | 12 | Phase 2 | Netherlands |
| 204 | NCT01894035 (ClinicalTrials.gov) | September 23, 2013 | 3/7/2013 | Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation | Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost. | Pulmonary Hypertension | Drug: Iloprost (Ventavis, BAYQ 6256) | Bayer | NULL | Completed | 18 Years | N/A | All | 13 | Portugal | |
| 205 | NCT01781052 (ClinicalTrials.gov) | September 11, 2013 | 22/1/2013 | Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients | DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients | Pulmonary Arterial Hypertension | Drug: Ventavis (Iloprost, BAYQ6256) | Bayer | NULL | Completed | 18 Years | N/A | All | 17 | N/A | France |
| 206 | NCT01739400 (ClinicalTrials.gov) | September 10, 2013 | 29/11/2012 | Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome | Long Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome | Pulmonary Arterial Hypertension | Drug: Macitentan 10 mg tablet, once daily. | Actelion | NULL | Terminated | 12 Years | N/A | All | 217 | Phase 3 | United States;Austria;Bulgaria;Chile;China;France;Germany;Greece;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;United Kingdom;Vietnam;Belgium;Canada;Czech Republic;Hungary;India;Israel;Italy;Netherlands;South Africa;Taiwan;Turkey |
| 207 | NCT01950585 (ClinicalTrials.gov) | September 6, 2013 | 21/9/2013 | Hydroxyurea in Pulmonary Arterial Hypertension | Hydroxyurea in Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Hydroxyurea | National Heart, Lung, and Blood Institute (NHLBI) | The Cleveland Clinic | Withdrawn | 18 Years | 110 Years | All | 0 | Early Phase 1 | United States |
| 208 | NCT01847014 (ClinicalTrials.gov) | September 1, 2013 | 2/5/2013 | Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument | AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Terminated | 18 Years | 80 Years | All | 4 | Phase 3 | United States |
| 209 | NCT01934582 (ClinicalTrials.gov) | August 2013 | 29/8/2013 | A Pharmacokinetic Substudy of the TDE-PH-304 Protocol | A Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 Protocol | Pulmonary Arterial Hypertension | Drug: UT-15C SR;Drug: treprostinil diethanolamine | United Therapeutics | NULL | Completed | 12 Years | 75 Years | All | 13 | Phase 3 | United States |
| 210 | NCT01897740 (ClinicalTrials.gov) | July 2013 | 8/7/2013 | Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil | A LOCAL, SINGLE-CENTRE, EXTENSION, OPEN LABEL ACCESS STUDY, TO PROVIDE SILDENAFIL THERAPY FOR SUBJECTS WHO COMPLETED A1481156 STUDY AND ARE JUDGED BY THE INVESTIGATOR TO DERIVE CLINICAL BENEFIT FROM CONTINUED TREATMENT WITH SILDENAFIL, PRIOR TO REIMBURSEMENT AND AVAILABILITY FOR SUBJECTS IN RUSSIAN FEDERATION | Pulmonary Arterial Hypertension | Drug: sildenafil | Pfizer | NULL | No longer available | 10 Years | 30 Years | All | Russian Federation | ||
| 211 | NCT01908699 (ClinicalTrials.gov) | May 31, 2013 | 16/7/2013 | Beraprost-314d Added-on to Tyvaso® (BEAT) | A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium 314d Modified Release Tablets;Drug: Placebo | Lung Biotechnology PBC | NULL | Completed | 18 Years | 80 Years | All | 273 | Phase 3 | United States;Israel |
| 212 | NCT01743001 (ClinicalTrials.gov) | May 21, 2013 | 29/11/2012 | Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome | Pulmonary Arterial Hypertension | Drug: Macitentan 10 mg;Drug: Placebo | Actelion | NULL | Completed | 12 Years | N/A | All | 226 | Phase 3 | United States;Austria;Bulgaria;Chile;China;France;Germany;Greece;Israel;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Turkey;United Kingdom;Vietnam;Belgium;Canada;Czech Republic;Hungary;India;Italy;Netherlands;South Africa;Taiwan |
| 213 | NCT03236818 (ClinicalTrials.gov) | May 2013 | 18/3/2013 | Goal Oriented Strategy to Preserve Ejection Fraction Trial | Raising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction Trial | Pulmonary Arterial Hypertension | Drug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan) | VU University Medical Center | NULL | Active, not recruiting | 18 Years | 80 Years | All | 30 | Phase 4 | Netherlands |
| 214 | NCT01841762 (ClinicalTrials.gov) | April 1, 2013 | 27/3/2013 | Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Completed | 18 Years | N/A | All | 284 | Phase 3 | United States |
| 215 | NCT04955990 (ClinicalTrials.gov) | December 9, 2012 | 29/6/2021 | A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants | An International, Non-Drug Interventional, Real-world Cohort of PAH Patients Newly Initiating PAH Therapy With Guideline-directed Assessments of Disease Severity | Pulmonary Arterial Hypertension | Drug: PAH Therapies | Actelion | NULL | Recruiting | 18 Years | N/A | All | 3000 | Phase 4 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Colombia;France;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Puerto Rico;Singapore;Spain;Sweden;Turkey;United Kingdom;Russian Federation |
| 216 | NCT01808313 (ClinicalTrials.gov) | December 1, 2012 | 28/2/2013 | Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH) | An Open Label Phase IIIb Study to Evaluate Efficacy and Safety of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH) | Vascular Disease | Drug: ambrisentan | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 134 | Phase 3 | China |
| 217 | NCT01586156 (ClinicalTrials.gov) | December 2012 | 23/4/2012 | PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol) | Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure | Pulmonary Hypertension | Drug: Carvedilol;Drug: placebo | The Cleveland Clinic | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | 65 Years | All | 30 | N/A | United States |
| 218 | NCT01517854 (ClinicalTrials.gov) | November 14, 2012 | 14/12/2011 | Revatio Portal-Pulmonary Arterial Hypertension Trial | Revatio Portal-Pulmonary Arterial Hypertension Trial (RePo1 Trial): A Randomized, Double-blinded, Placebo-controlled, Multi-center Study to Evaluate the Effects of Sildenafil Citrate (Revatio) 20 mg TID on Patients With Portal Pulmonary Arterial Hypertension (PPAH) | Portopulmonary Hypertension | Drug: Sildenafil;Drug: Placebo | University Health Network, Toronto | NULL | Terminated | 18 Years | 75 Years | All | 12 | Phase 2 | Canada |
| 219 | NCT01545336 (ClinicalTrials.gov) | October 2012 | 29/2/2012 | Anastrozole in Patients With Pulmonary Arterial Hypertension | A Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Anastrozole;Drug: Placebo | University of Pennsylvania | NULL | Completed | 18 Years | N/A | All | 18 | Phase 2 | United States |
| 220 | NCT02169752 (ClinicalTrials.gov) | September 2012 | 6/5/2014 | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Pre-Pulmonary Atrial Hypertension | Drug: Ambrisentan | National Jewish Health | NULL | Terminated | 18 Years | 80 Years | All | 7 | N/A | United States |
| 221 | NCT01642407 (ClinicalTrials.gov) | August 24, 2012 | 15/6/2012 | Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension | A Phase 3, Multi-center, Open-label Study To Investigate Safety, Efficacy, And Tolerability Of Sildenafil Citrate In Pediatric Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Hypertension, Pulmonary | Drug: Sildenafil | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 1 Year | 17 Years | All | 6 | Phase 4 | Japan |
| 222 | NCT01484431 (ClinicalTrials.gov) | July 17, 2012 | 30/11/2011 | A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension | A Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Tadalafil- Tablet or Oral suspension | Eli Lilly and Company | NULL | Completed | 6 Months | 17 Years | All | 20 | Phase 1/Phase 2 | United States;Canada;France;Poland;Spain;United Kingdom |
| 223 | NCT01615627 (ClinicalTrials.gov) | July 1, 2012 | 6/6/2012 | Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain | Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain | Pulmonary Arterial Hypertension | Drug: HypotonicTreprostinil Solution;Drug: Eutonic Treprostinil Solution | Jewish General Hospital | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 4 | Canada |
| 224 | NCT01645826 (ClinicalTrials.gov) | July 2012 | 18/10/2011 | Efficacy Study of Cardizem in Pulmonary Arterial Hypertension | Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension. | Idiopathic Pulmonary Arterial Hypertension;Primary Pulmonary Hypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary Hypertension | Drug: Diltiazem Hydrochloride;Drug: Sugar Pill | University of South Florida | NULL | Withdrawn | 18 Years | N/A | All | 0 | N/A | United States |
| 225 | NCT01647945 (ClinicalTrials.gov) | July 2012 | 18/7/2012 | FK506 (Tacrolimus) in Pulmonary Arterial Hypertension | Single-Center Randomized Controlled Phase II Study of Safety and Efficacy of FK-506 (Tacrolimus) in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Placebo;Drug: FK506 level < 2 ng/ml;Drug: FK506 level 2-3 ng/ml;Drug: FK506 level 3-5 ng/ml | Edda Spiekerkoetter | Stanford University | Completed | 18 Years | 70 Years | All | 23 | Phase 2 | United States |
| 226 | NCT01523548 (ClinicalTrials.gov) | July 2012 | 27/1/2012 | Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension | Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Carbon Monoxide | University of Illinois at Chicago | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI) | Withdrawn | 18 Years | N/A | All | 0 | Phase 1/Phase 2 | United States |
| 227 | NCT01560624 (ClinicalTrials.gov) | June 26, 2012 | 9/3/2012 | Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension | Drug: Treprostinil Diolamine;Drug: Placebo | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 690 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom |
| 228 | NCT01469169 (ClinicalTrials.gov) | June 19, 2012 | 8/11/2011 | Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study | A Multi-center, Non-randomized, Open Label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of BAY q 6256 (Iloprost) Inhalation in Patients With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Iloprost (Ventavis inhaled, BAYQ6256) | Bayer | NULL | Completed | 18 Years | 75 Years | All | 27 | Phase 3 | Japan |
| 229 | NCT01560637 (ClinicalTrials.gov) | May 2012 | 9/3/2012 | An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension | 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 | Drug: UT-15C (treprostinil diethanolamine) | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 471 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom |
| 230 | NCT01588405 (ClinicalTrials.gov) | April 2012 | 6/1/2012 | Remodulin® to Oral Treprostinil Transition | A Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: UT-15C SR | United Therapeutics | NULL | Completed | 15 Years | 80 Years | All | 33 | Phase 2 | United States |
| 231 | NCT02847260 (ClinicalTrials.gov) | April 2012 | 25/7/2016 | Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID) | A 16 Week, Open Label, Multi-centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Remodulin | United Therapeutics | NULL | Completed | 18 Years | N/A | All | 39 | Phase 4 | NULL |
| 232 | NCT01433328 (ClinicalTrials.gov) | January 2012 | 9/9/2011 | Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain | Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain | Pulmonary Arterial Hypertension | Drug: Lidocaine;Drug: Placebo | Jewish General Hospital | NULL | Terminated | 18 Years | 85 Years | All | 4 | Phase 4 | Canada |
| 233 | NCT01462565 (ClinicalTrials.gov) | November 1, 2011 | 13/10/2011 | Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH) | A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN® in Subjects With Pulmonary Arterial Hypertension (PAH). (FLOLAN® is a Registered Trademark of the GlaxoSmithKline Group of Companies.) | Hypertension, Pulmonary | Drug: current marketed FLOLAN (epoprostenol sodium);Drug: new thermo stable formulation of epoprostenol sodium | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 16 | Phase 4 | United States;Canada;Netherlands |
| 234 | NCT01431326 (ClinicalTrials.gov) | November 2011 | 17/8/2011 | Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care | Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care | Adenovirus;Anesthesia;Anxiety;Anxiolysis;Autism;Autistic Disorder;Bacterial Meningitis;Bacterial Septicemia;Benzodiazepine;Bipolar Disorder;Bone and Joint Infections;Central Nervous System Infections;Convulsions;Cytomegalovirus Retinitis;Early-onset Schizophrenia Spectrum Disorders;Epilepsy;General Anesthesia;Gynecologic Infections;Herpes Simplex Virus;Infantile Hemangioma;Infection;Inflammation;Inflammatory Conditions;Intra-abdominal Infections;Lower Respiratory Tract Infections;Migraines;Pain;Pneumonia;Schizophrenia;Sedation;Seizures;Skeletal Muscle Spasms;Skin and Skin-structure Infections;Treatment-resistant Schizophrenia;Urinary Tract Infections;Withdrawal;Sepsis;Gram-negative Infection;Bradycardia;Cardiac Arrest;Cardiac Arrhythmia;Staphylococcal Infections;Nosocomial Pneumonia;Neuromuscular Blockade;Methicillin Resistant Staphylococcus Aureus;Endocarditis;Neutropenia;Headache;Fibrinolytic Bleeding;Pulmonary Arterial Hypertension;CMV Retinitis;Hypertension;Chronic Kidney Diseases;Hyperaldosteronism;Hypokalemia;Heart Failure;Hemophilia;Heavy Menstrual Bleeding;Insomnia | Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care: | Daniel Benjamin | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);The Emmes Company, LLC | Completed | N/A | 21 Years | All | 3520 | United States;Canada;Israel;Singapore;United Kingdom;Australia | |
| 235 | NCT01447628 (ClinicalTrials.gov) | October 2011 | 4/10/2011 | IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients | What is the Effect of Intravenous Iron Supplementation on Cardiopulmonary Haemodynamics, Exercise Capacity and Quality of Life in Patients With IPAH and Iron Deficiency? | Pulmonary Arterial Hypertension;Iron Deficiency | Drug: Saline;Drug: Ferinject or CosmoFer | Imperial College London | Fu Wai Hospital, Beijing, China | Completed | 16 Years | 75 Years | All | 40 | Phase 2 | China;Germany;United Kingdom |
| 236 | NCT01477333 (ClinicalTrials.gov) | October 2011 | 14/11/2011 | Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso® | An Evaluation of the Safety and Efficacy of the Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso® | Pulmonary Arterial Hypertension | Drug: UT-15C SR;Drug: Tyvaso Inhalation Solution | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 18 | Phase 2 | United States |
| 237 | NCT01548950 (ClinicalTrials.gov) | September 2011 | 5/3/2012 | Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension | Combined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension (PAH-CHD) | Congenital Heart Disease;Pulmonary Arterial Hypertension | Drug: Sildenafil singly or in association with Bosentan | University of Sao Paulo General Hospital | Instituto do Coracao;Fundação de Amparo à Pesquisa do Estado de São Paulo | Completed | 2 Months | N/A | All | 50 | N/A | Brazil |
| 238 | NCT01582438 (ClinicalTrials.gov) | August 17, 2011 | 19/4/2012 | An Open Label Access Study For Subjects Who Completed A1481156 | A Local, Multicentre, Open Label Access Study, To Provide Sildenafil Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil For Subjects In India | Pulmonary Arterial Hypertension | Drug: Access program - sildenafil citrate, Viagra, Revatio | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | No longer available | 12 Years | 30 Years | All | India | ||
| 239 | NCT01757808 (ClinicalTrials.gov) | August 2011 | 26/4/2012 | A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension | A Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Ranolazine;Drug: Placebo | University of Chicago | NULL | Completed | 18 Years | 72 Years | All | 12 | Phase 1 | United States |
| 240 | NCT01365585 (ClinicalTrials.gov) | July 2011 | 1/6/2011 | Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial Hypertension | Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: sildenafil citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | N/A | All | 227 | Germany;Ireland | |
| 241 | NCT01086540 (ClinicalTrials.gov) | June 24, 2011 | 11/3/2010 | Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | Systemic Sclerosis-Associated PAH | Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Completed | 18 Years | 75 Years | All | 57 | Phase 2 | United States |
| 242 | NCT01342952 (ClinicalTrials.gov) | June 21, 2011 | 26/4/2011 | Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529 | An Open-label, Long Term Extension Study for Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years Who Have Participated in AMB112529 and in Whom Continued Treatment With Ambrisentan is Desired | Hypertension, Pulmonary | Drug: Ambrisentan | GlaxoSmithKline | NULL | Completed | 8 Years | 18 Years | All | 38 | Phase 2 | United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Mexico;Netherlands |
| 243 | NCT01389206 (ClinicalTrials.gov) | June 1, 2011 | 6/7/2011 | Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program | Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program | Pulmonary Arterial Hypertension | Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi | Actelion | Canadian Heart Research Centre | Completed | 18 Years | N/A | All | 797 | United States;Puerto Rico | |
| 244 | NCT01470144 (ClinicalTrials.gov) | June 1, 2011 | 28/10/2011 | Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension | An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Epoprostenol | Actelion | Chiltern International Ltd.;Effi-stat | Completed | N/A | N/A | All | 41 | Phase 3 | Belgium;Canada;France;Italy;Netherlands;Spain |
| 245 | NCT01319045 (ClinicalTrials.gov) | June 2011 | 18/3/2011 | Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease | Pulmonary Arterial Hypertension;Congenital Heart Disease;Eisenmenger's Syndrome | Drug: Iloprost | University of California, Los Angeles | Actelion | Terminated | 18 Years | N/A | All | 5 | N/A | United States | |
| 246 | NCT01392495 (ClinicalTrials.gov) | June 2011 | 11/7/2011 | Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) | An Open-label Extension Study to CQTI571A2102 to Evaluate the Long-term Safety, Tolerability and Efficacy of QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Imatinib | Novartis Pharmaceuticals | NULL | Terminated | N/A | N/A | All | 17 | Phase 3 | United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Turkey |
| 247 | NCT01330108 (ClinicalTrials.gov) | May 2011 | 4/4/2011 | Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension | Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension | Pulmonary Arterial Hypertension | Drug: ambrisentan | University of Alabama at Birmingham | NULL | Completed | 19 Years | N/A | All | 32 | Phase 4 | United States |
| 248 | EUCTR2010-021793-12-ES (EUCTR) | 28/04/2011 | 03/03/2011 | Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar | Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar | Hipertensión arterial pulmonar (PAH) en niños. MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película INN or Proposed INN: BOSENTAN MONOHIDRATO Other descriptive name: BOSENTAN MONOHIDRATO | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Czech Republic;Hungary;Spain;Netherlands;Germany;Italy | |||
| 249 | NCT01392469 (ClinicalTrials.gov) | April 20, 2011 | 10/5/2011 | Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants | A Non-Randomized, Multiple Dose, Three Treatment Period, Open-Label, Single Sequence, Single Group Study to Evaluate the Pharmacokinetic Effect of Two Doses of QTI571 (Imatinib) on the Co-administered Drugs Sildenafil and Bosentan in Pulmonary Arterial Hypertension (PAH) Patients | Pulmonary Arterial Hypertension | Drug: Imatinib;Drug: Sildenafil;Drug: Bosentan | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 21 | Phase 3 | United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey |
| 250 | NCT01338415 (ClinicalTrials.gov) | March 8, 2011 | 15/4/2011 | FUTURE 3 Study Extension | A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Bosentan | Actelion | NULL | Completed | 3 Months | 12 Years | All | 58 | Phase 3 | United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic;Netherlands |
| 251 | NCT01223352 (ClinicalTrials.gov) | March 8, 2011 | 12/10/2010 | Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension | An Open-label, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: bosentan | Actelion | NULL | Completed | 3 Months | 12 Years | All | 64 | Phase 3 | United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic |
| 252 | NCT01302444 (ClinicalTrials.gov) | March 2011 | 16/2/2011 | Treprostinil Combined With Tadalafil for Pulmonary Hypertension | Randomized Placebo Controlled Trial of Treprostinil Infusion Combined With Oral Tadalafil or Placebo in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Tadalafil;Drug: Placebo | Rhode Island Hospital | United Therapeutics | Terminated | 18 Years | 80 Years | All | 1 | Phase 4 | United States |
| 253 | NCT01431716 (ClinicalTrials.gov) | March 2011 | 7/9/2011 | Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension | A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: EFI/ACT-385781A | Actelion | NULL | Completed | 18 Years | N/A | All | 42 | Phase 3 | Belgium;Canada;France;Italy;Netherlands;Spain |
| 254 | ChiCTR-ONC-11001799 | 2011-02-17 | 2011-12-15 | A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease | A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease | pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease | All groups:Bosentan therapy ; | Beijing Anzhen Hospital | NULL | Completed | 0 | 18 | Both | All groups:50; | China | |
| 255 | NCT01332331 (ClinicalTrials.gov) | January 4, 2011 | 24/3/2011 | Efficacy and Safety of Ambrisentan in Children 8-18yrs | A Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years | Hypertension, Pulmonary | Drug: Ambrisentan - low dose;Drug: Ambrisentan - high dose | GlaxoSmithKline | NULL | Terminated | 8 Years | 18 Years | All | 41 | Phase 2 | United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Greece;Mexico;Netherlands |
| 256 | NCT01028651 (ClinicalTrials.gov) | January 2011 | 8/12/2009 | A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension | An Open-Label Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension | Portopulmonary Hypertension;Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: Treprostinil | United Therapeutics | University of California, Los Angeles;Brigham and Women's Hospital;University of Texas;Emory University | Completed | N/A | N/A | All | 13 | N/A | United States |
| 257 | EUCTR2010-021825-11-ES (EUCTR) | 22/12/2010 | 12/11/2010 | Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3 | Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3 | Hpertensión arterial pulmonar (PAH) en niños MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película INN or Proposed INN: BOSENTAN MONOHIDRATO Other descriptive name: BOSENTAN MONOHIDRATO | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 3 | Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy | ||
| 258 | NCT01406327 (ClinicalTrials.gov) | December 14, 2010 | 28/7/2011 | Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension) | Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension) | Hypertension, Pulmonary | Drug: Ambrisentan | GlaxoSmithKline | NULL | Completed | N/A | N/A | All | 900 | NULL | |
| 259 | NCT01266265 (ClinicalTrials.gov) | December 2010 | 22/12/2010 | Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies | A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution | Pulmonary Arterial Hypertension | Drug: inhaled prostacyclin;Drug: prostacyclin;Drug: subcutaneous and intravenous prostacyclin;Drug: oral ERA;Drug: oral PDE5 inhibitors | United Therapeutics | NULL | Completed | N/A | N/A | All | 1333 | N/A | United States |
| 260 | NCT01251835 (ClinicalTrials.gov) | December 2010 | 1/12/2010 | Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan | A Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy Subjects | Pulmonary Arterial Hypertension | Drug: Sitaxsentan alone;Drug: Sitaxsentan;Drug: Rifampin | Pfizer | NULL | Withdrawn | 21 Years | 55 Years | Both | 0 | Phase 1 | NULL |
| 261 | NCT01260454 (ClinicalTrials.gov) | November 2010 | 9/12/2010 | The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain | The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain | Pulmonary Hypertension;Pulmonary Arterial Hypertension | Drug: Qutenza (8% capsaicin) | University of Rochester | United Therapeutics | Completed | 15 Years | 80 Years | All | 6 | Phase 2 | United States |
| 262 | NCT01210443 (ClinicalTrials.gov) | November 2010 | 11/8/2010 | Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients | A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Sitaxentan | Pfizer | NULL | Terminated | 16 Years | 80 Years | All | 2 | Phase 3 | Japan |
| 263 | NCT01244620 (ClinicalTrials.gov) | November 2010 | 15/11/2010 | A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses | A Phase 1, Open Label, Randomized, Four Period, Crossover, Multiple Dose Study To Assess The Pharmacokinetic Interaction Between Sitaxsentan and Tadalafil and The Effect Of Sildenafil On Sitaxsentan PK In Healthy Subjects | Pulmonary Arterial Hypertension | Drug: sitaxentan;Drug: tadalafil;Drug: sitaxsentan;Drug: sildenafil | Pfizer | NULL | Terminated | 21 Years | 55 Years | All | 16 | Phase 1 | Singapore |
| 264 | EUCTR2010-019547-19-ES (EUCTR) | 06/10/2010 | 15/07/2010 | Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | Hipertensión arterial pulmonar MedDRA version: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar MedDRA version: 13;Level: PT;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar | Trade Name: VOLIBRIS 10 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | ||
| 265 | NCT01178073 (ClinicalTrials.gov) | October 1, 2010 | 15/7/2010 | A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: ambrisentan;Drug: tadalafil | GlaxoSmithKline | Gilead Sciences | Completed | 18 Years | 75 Years | All | 610 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Greece;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom |
| 266 | NCT01092559 (ClinicalTrials.gov) | October 2010 | 16/2/2010 | Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide | An Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery System | Pulmonary Arterial Hypertension | Drug: Nitric Oxide generated by the GeNO nitrosyl delivery system | Geno LLC | NULL | Completed | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 267 | NCT01054105 (ClinicalTrials.gov) | October 2010 | 21/1/2010 | Effect of BMPR-2 Gene Mutations on Hemodynamic Response by Iloprost Inhalation in Pulmonary Arterial Hypertension | The Prevalence of BMPR-2 Gene Mutations in Korean Patients With Pulmonary Arterial Hypertension (PAH) and the Effects of Gene Mutations on Hemodynamic Response by Drug Therapy | Pulmonary Arterial Hypertension | Drug: Iloprost | Gachon University Gil Medical Center | Seoul National University Hospital;Seoul National University Bundang Hospital;The Catholic University of Korea;Bayer | Completed | 20 Years | 80 Years | All | 73 | Korea, Republic of | |
| 268 | NCT01094067 (ClinicalTrials.gov) | September 1, 2010 | 25/3/2010 | Tezosentan in Patients With Pulmonary Arterial Hypertension | Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both. | Pulmonary Arterial Hypertension | Drug: ACT-050089;Other: Placebo | Idorsia Pharmaceuticals Ltd. | NULL | Terminated | 18 Years | N/A | All | 2 | Phase 2 | United States;France;Japan |
| 269 | NCT01165047 (ClinicalTrials.gov) | September 2010 | 16/7/2010 | Nitric Oxide, GeNO Nitrosyl Delivery System | An Open Label, Non-Randomized Pilot Study to Evaluate the Safety and Performance of the GeNO Nitrosyl Delivery System in Subjects Being Evaluated for Orthotopic Heart Transplantation (OHT), or Left Ventricular Assist Device (LVAD) Implantation | Pulmonary Arterial Hypertension | Drug: Nitric Oxide | Aurora Health Care | NULL | Completed | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 270 | NCT01355380 (ClinicalTrials.gov) | August 5, 2010 | 17/5/2011 | Efficacy of Ventavis Used in Real-life Setting. | The Efficacy of Inhaled Iloprost in Patients Treated Within the Pulmonary Arterial Hypertension Therapeutic Programme. | Pulmonary Arterial Hypertension | Drug: Inhaled iloprost (Ventavis, BAYQ6256) | Bayer | NULL | Completed | 18 Years | N/A | All | 55 | N/A | Poland |
| 271 | NCT01204853 (ClinicalTrials.gov) | August 2010 | 6/8/2010 | A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients | A Phase 3, Multi-Center, Open Label Study To Evaluate The Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Sitaxentan | Pfizer | NULL | Terminated | 16 Years | 80 Years | All | 2 | Phase 3 | Japan |
| 272 | NCT01179334 (ClinicalTrials.gov) | August 2010 | 10/8/2010 | Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters. | An Interaction Study to Evaluate Changes in Blood Pressure Following 1, 1.5, 2, and 2.5 mg Riociguat Tid (Dose Titration) Compared to Placebo Treatment on the Background of Stable Sildenafil Pretreatment in Subjects With Symptomatic Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Riociguat (Adempas, BAY63-2521);Drug: Placebo;Drug: Sildenafil | Bayer | NULL | Completed | 18 Years | 75 Years | All | 18 | Phase 2 | United States;Austria;Czech Republic;Germany;Italy;New Zealand;Poland;Spain;United Kingdom |
| 273 | NCT01077297 (ClinicalTrials.gov) | August 2010 | 25/2/2010 | Tezosentan in Pulmonary Arterial Hypertension | Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines | Pulmonary Arterial Hypertension | Drug: Tezosentan | Idorsia Pharmaceuticals Ltd. | NULL | Terminated | 18 Years | N/A | All | 3 | Phase 2 | United States;France;Switzerland |
| 274 | NCT01268553 (ClinicalTrials.gov) | August 2010 | 29/12/2010 | Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication | Transition From Parenteral Prostanoids to Inhaled Treprostinil | Pulmonary Arterial Hypertension | Drug: Treprostinil | Los Angeles Biomedical Research Institute | United Therapeutics | Completed | 18 Years | 80 Years | All | 6 | Phase 4 | United States |
| 275 | EUCTR2009-011150-17-ES (EUCTR) | 13/07/2010 | 02/06/2010 | AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Hipertensión arterial pulmonar MedDRA version: 11;Level: PT;Classification code 10064911;Term: Hipertensión arterial pulmonar MedDRA version: 11;Level: LLT;Term: Hipertensión arterial pulmonar | Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN Trade Name: CIALIS 20 mg comprimidos recubiertos con película INN or Proposed INN: TADALAFILO Other descriptive name: TADALAFIL | GlaxoSmithKline,S.A. | NULL | Not Recruiting | Female: yes Male: yes | 352 | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 276 | NCT01112306 (ClinicalTrials.gov) | July 2010 | 8/4/2010 | ACT-293987 in Pulmonary Arterial Hypertension | Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: ACT-293987 | Actelion | NULL | Completed | 18 Years | N/A | All | 709 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic;Italy |
| 277 | NCT01179737 (ClinicalTrials.gov) | July 2010 | 3/8/2010 | Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) | A 24 Week, Randomized, Double Blind, Multicenter, Placebocontrolled Efficacy, Safety, Tolerability and PK Trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Nilotinib;Drug: Placebo to nilotinib | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 23 | Phase 2 | United States;Canada;Germany;Korea, Republic of;Singapore;Switzerland;Hungary;Italy |
| 278 | NCT00796510 (ClinicalTrials.gov) | July 2010 | 20/11/2008 | Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety | A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: Sitaxsentan;Drug: Sitaxsentan and Sildenafil | Pfizer | NULL | Terminated | 16 Years | 80 Years | All | 3 | Phase 3 | United States;Romania;Ukraine;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;India;Mexico;Peru;Philippines;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand |
| 279 | NCT01305252 (ClinicalTrials.gov) | July 2010 | 2/11/2010 | A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil). | CombinatiON Up-FRON t Therapy for PAH - A Phase 4, Randomized, Multicenter Study of Inhaled Treprostinil in Treatment naïve Pulmonary Arterial Hypertension Patients Starting on Tadalafil | Hypertension, Pulmonary | Drug: treprostinil inhalations;Drug: tadalafil | Stanford University | Northwestern University | Completed | 18 Years | 69 Years | All | 21 | Phase 4 | United States |
| 280 | NCT01174173 (ClinicalTrials.gov) | June 2010 | 23/7/2010 | Ranolazine and Pulmonary Hypertension | Effects of Ranolazine in Patients With Angina Due to Right Ventricular Ischemia in Pulmonary Arterial Hypertension | Angina;Pulmonary Arterial Hypertension | Drug: Ranolazine | Northwestern University | Gilead Sciences | Completed | 18 Years | 80 Years | All | 11 | Phase 3 | United States |
| 281 | NCT00964678 (ClinicalTrials.gov) | June 2010 | 24/8/2009 | Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension | Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Carvedilol | Virginia Commonwealth University | GlaxoSmithKline | Completed | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | United States |
| 282 | NCT01105117 (ClinicalTrials.gov) | May 2010 | 15/4/2010 | Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401 | An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan® | Actelion | NULL | Completed | 18 Years | 65 Years | All | 2 | Phase 4 | United States |
| 283 | NCT01117987 (ClinicalTrials.gov) | April 2010 | 3/5/2010 | Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) | An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension | Pulmonary Arterial Hypertension | Drug: Imatinib;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 144 | Phase 3 | United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Switzerland;United Kingdom;Sweden |
| 284 | NCT00995566 (ClinicalTrials.gov) | April 2010 | 17/9/2009 | A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin | Thelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin | Pulmonary Arterial Hypertension | Drug: Sitaxentan sodium | Pfizer | NULL | Terminated | 18 Years | N/A | All | 54 | N/A | Belgium;France;Germany;Sweden |
| 285 | NCT01105091 (ClinicalTrials.gov) | March 2010 | 15/4/2010 | Epoprostenol for Injection in Pulmonary Arterial Hypertension | A Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan® | Actelion | NULL | Completed | 18 Years | 65 Years | All | 30 | Phase 4 | United States |
| 286 | NCT01083524 (ClinicalTrials.gov) | March 2010 | 8/3/2010 | Dichloroacetate (DCA) for the Treatment of Pulmonary Arterial Hypertension | A Phase I, Open-Label, Two Centre Study to Evaluate Dichloroacetate(DCA) in Advanced Pulmonary Arterial Hypertension. | Pulmonary Hypertension (Idiopathic, Familial or Anorexigen-associated) | Drug: Dichloroacetate Sodium | University of Alberta | Imperial College London | Completed | 18 Years | N/A | Both | 30 | Phase 1 | Canada;United Kingdom |
| 287 | NCT00989963 (ClinicalTrials.gov) | February 1, 2010 | 5/10/2009 | Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH) | A 12-week, Double-blind, International, Multicenter, Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium Modified Release | Lung Biotechnology PBC | NULL | Completed | 18 Years | 75 Years | All | 36 | Phase 2 | United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic |
| 288 | NCT01042158 (ClinicalTrials.gov) | January 2010 | 4/1/2010 | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | Pulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary Hypertension | Drug: tadalafil and ambrisentan upfront combination therapy | Johns Hopkins University | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford University | Completed | 18 Years | N/A | All | 25 | Phase 4 | United States |
| 289 | NCT01148836 (ClinicalTrials.gov) | January 2010 | 19/3/2010 | Coenzyme Q-10 and Pulmonary Arterial Hypertension | Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Dietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects;Dietary Supplement: Coenzyme Q-10 in Normal Control subjects | The Cleveland Clinic | NULL | Completed | 18 Years | 55 Years | All | 18 | N/A | United States |
| 290 | NCT01445873 (ClinicalTrials.gov) | December 1, 2009 | 30/9/2011 | Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH) | NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension | Drug: Sitaxentan sodium | Pfizer | NULL | Completed | 18 Years | N/A | All | 36 | NULL | |
| 291 | NCT01106014 (ClinicalTrials.gov) | December 2009 | 2/4/2010 | Selexipag (ACT-293987) in Pulmonary Arterial Hypertension | A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Selexipag;Drug: Placebo | Actelion | NULL | Completed | 18 Years | 75 Years | All | 1156 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czech Republic;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom |
| 292 | NCT00990314 (ClinicalTrials.gov) | November 30, 2009 | 5/10/2009 | Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients | An Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium Modified Release | Lung Biotechnology PBC | NULL | Completed | 18 Years | 75 Years | All | 31 | Phase 2 | United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic |
| 293 | EUCTR2009-009366-13-ES (EUCTR) | 18/11/2009 | 24/09/2009 | Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Hipertensión Arterial PulmonarPulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: treprostinil dietanolamina Product Code: UT-15C SR INN or Proposed INN: treprostinil dietanolamina Product Name: treprostinil dietanolamina Product Code: UT-15C INN or Proposed INN: treprostinil dietanolamina Product Name: treprostinil dietanolamina Product Code: UT-15C INN or Proposed INN: treprostinil dietanolamina | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Portugal;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 294 | EUCTR2009-012057-38-ES (EUCTR) | 02/10/2009 | 02/07/2009 | Ensayo clínico multicéntrico, aleatorizado controlado con placebo, doble ciego y de 24 semanas de duración, para evaluar la eficacia y seguridad de QTI571 oral como terapia adicional en el tratamiento de la hipertensión arterial pulmonar severa: Imatinib en hipertensión arterial pulmonar, un estudio aleatorizado de eficacia (IMPRES) - IMPRES | Ensayo clínico multicéntrico, aleatorizado controlado con placebo, doble ciego y de 24 semanas de duración, para evaluar la eficacia y seguridad de QTI571 oral como terapia adicional en el tratamiento de la hipertensión arterial pulmonar severa: Imatinib en hipertensión arterial pulmonar, un estudio aleatorizado de eficacia (IMPRES) - IMPRES | Pacientes con Hipertensión Arterial Pulmonar (HAP) que tienen una RVP>1000 dynes.sec.cm-5 a pesar de estar en tratamiento con dos o mas terapias específicas para la HAP. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: GLIVEC 100 mg comprimidos recubiertos con película INN or Proposed INN: IMATINIB Other descriptive name: IMATINIB | Novartis Farmacéutica SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | France;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 295 | EUCTR2008-007455-26-ES (EUCTR) | 28/09/2009 | 23/04/2009 | A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial HypertensionEstudio en fase II , de asignación aleatoria, doblemente ciego, controlado con placebo y multicéntrico. Estudio de búsqueda de dosis con cicletanina en sujetos con hipertensión arterial pulmonar | A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial HypertensionEstudio en fase II , de asignación aleatoria, doblemente ciego, controlado con placebo y multicéntrico. Estudio de búsqueda de dosis con cicletanina en sujetos con hipertensión arterial pulmonar | Pulmonary hypertension (PH) is a serious and life-threatening disease of the pulmonary vasculature, characterized by profound vasoconstriction and an abnormal proliferation of smooth muscle cells in the walls of the pulmonary arteries.La hipertensión pulmonar (PH) es una enfermedad grave y potencialmente mortal de la vasculatura pulmonar, caracterizada por una vasoconstricción profunda y una proliferación anómala de células musculares lisas en las paredes de las arterías pulmonares MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Cicletanine hydrochloride Product Name: Cicletanine hydrochloride | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United Kingdom;Germany;Belgium;Spain;Austria | ||
| 296 | JPRN-JapicCTI-121998 | 01/9/2009 | 26/10/2012 | Bosentan PAH (WHO-FC II) | Open label multicenter study to assess the efficacy, safety, and tolerability of bosentan in Japanese patients with pulmonary arterial hypertension (PAH) in WHO functional class II. | Pulmonary arterial hypertension (PAH) | Intervention name : Ro47-0203 INN of the intervention : Bosentan Dosage And administration of the intervention : Oral administration, Initial dose: 62.5 mg b.i.d. for 4 weeks for all patients, Target dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg) | Actelion Pharmaceuticals Japan Ltd. | NULL | 18 | 74 | BOTH | 16 | Phase 3 | NULL | |
| 297 | NCT00942708 (ClinicalTrials.gov) | September 2009 | 19/7/2009 | Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension | Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Fluoxetine | University of Texas Southwestern Medical Center | National Center for Research Resources (NCRR) | Completed | 16 Years | 75 Years | All | 6 | Phase 2 | United States |
| 298 | NCT00902174 (ClinicalTrials.gov) | September 2009 | 13/5/2009 | Imatinib (QTI571) in Pulmonary Arterial Hypertension | A 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES) | Pulmonary Arterial Hypertension | Drug: imatinib mesylate;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 202 | Phase 3 | United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Switzerland;United Kingdom |
| 299 | EUCTR2008-003482-68-ES (EUCTR) | 08/06/2009 | 24/10/2008 | Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg ,tid )administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática-Estudio PATENT -1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg ,tid )administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática-Estudio PATENT -1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Hipertensión Arterial Pulmonar (HAP) Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 300 | NCT00887978 (ClinicalTrials.gov) | June 2009 | 23/4/2009 | Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: UT-15C SR;Drug: Placebo | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 310 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Portugal;Spain;Sweden;United Kingdom;Ireland;Norway |
| 301 | NCT00796666 (ClinicalTrials.gov) | May 2009 | 20/11/2008 | Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil | A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639) | Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: Sitaxsentan;Drug: Sitaxsentan and Sildenafil | Pfizer | NULL | Terminated | 16 Years | 80 Years | All | 131 | Phase 3 | United States;Argentina;Bulgaria;Chile;China;Colombia;Czech Republic;India;Malaysia;Mexico;Peru;Romania;Russian Federation;Serbia;South Africa;Thailand;Turkey;Ukraine;Costa Rica;Dominican Republic;Philippines;Saudi Arabia;Slovakia |
| 302 | NCT00853112 (ClinicalTrials.gov) | April 2009 | 27/2/2009 | A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension | A Phase 2a, Randomized, Double Blind, Placebo-controlled, Parallel Group Study Investigating The Dose-response Of Pf-00489791 On Acute Hemodynamics In Subjects With Idiopathic And Familial Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: PF-00489791;Drug: placebo;Drug: sildenafil | Pfizer | NULL | Terminated | 18 Years | N/A | All | 48 | Phase 2 | United States;Canada;Germany;India;Russian Federation;Spain;Sweden;Switzerland;Belgium |
| 303 | NCT00878943 (ClinicalTrials.gov) | March 31, 2009 | 8/4/2009 | Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study | A Local, Multi-centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy. | Pulmonary Arterial Hypertension | Drug: Sildenafil citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | No longer available | 18 Years | N/A | All | India | ||
| 304 | NCT00863681 (ClinicalTrials.gov) | March 12, 2009 | 13/3/2009 | BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension | Long-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Riociguat (BAY63-2521) | Bayer | NULL | Completed | 18 Years | 80 Years | All | 396 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation;Singapore;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;Czech Republic;Ireland;Israel;Netherlands;New Zealand;Slovakia;Spain |
| 305 | NCT00792571 (ClinicalTrials.gov) | February 28, 2009 | 14/11/2008 | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients. | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium Modified Release | Lung Biotechnology PBC | NULL | Completed | 18 Years | 75 Years | All | 18 | Phase 2 | United States;Belgium;Ireland |
| 306 | NCT00781885 (ClinicalTrials.gov) | January 31, 2009 | 27/10/2008 | A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients | A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients | Pulmonary Arterial Hypertension | Drug: Beraprost sodium modified release | Lung Biotechnology PBC | NULL | Completed | 18 Years | 75 Years | All | 19 | Phase 2 | United States;Belgium;Ireland |
| 307 | EUCTR2008-003572-21-ES (EUCTR) | 15/01/2009 | 15/10/2008 | Estudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION | Estudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION | Hipertensión arterial pulmonarPulmonary arterial hypertension. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: PF-00489791 Product Name: PF-00489791 Product Name: PF-00489791 Trade Name: REVATIO 20 mg, comprimidos recubiertos con película INN or Proposed INN: SILDENAFILO Other descriptive name: SILDENAFIL | Pfizer, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 79 | Phase 2 | Belgium;Spain;Germany;Sweden | ||
| 308 | NCT00810693 (ClinicalTrials.gov) | December 2008 | 17/12/2008 | A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH) | Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: Riociguat (Adempas, BAY63-2521);Drug: Placebo | Bayer | NULL | Completed | 18 Years | 80 Years | All | 445 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;France;Germany;Greece;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Singapore;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;Slovakia |
| 309 | NCT00795639 (ClinicalTrials.gov) | December 2008 | 20/11/2008 | Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: Sitaxsentan;Drug: Placebo | Pfizer | NULL | Terminated | 16 Years | 80 Years | All | 183 | Phase 3 | United States;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;Guatemala;India;Malaysia;Mexico;Peru;Philippines;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand;Turkey;Ukraine;Egypt;Jordan;Lebanon;United Arab Emirates |
| 310 | NCT00667823 (ClinicalTrials.gov) | October 17, 2008 | 24/4/2008 | Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension | Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Completed | 12 Years | N/A | All | 550 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;Finland;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Japan;Korea, Republic of;Norway;Portugal;Spain |
| 311 | NCT00800592 (ClinicalTrials.gov) | October 2008 | 19/11/2008 | Sildenafil IV Bolus Study | An Open Single Dose Study To Assess The Safety, Tolerability And Pharmacokinetics Of An Intravenous Bolus Dose (10 Mg) Of Sildenafil In Patients With Pulmonary Arterial Hypertension (PAH). | Hypertension, Pulmonary | Drug: sildenafil | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | N/A | All | 12 | Phase 1 | Belgium |
| 312 | NCT00866983 (ClinicalTrials.gov) | October 2008 | 20/3/2009 | Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil | A Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil. | Pulmonary Arterial Hypertension | Drug: sildenafil (Revatio) 20 mg TID | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | No longer available | 18 Years | N/A | All | Brazil | ||
| 313 | NCT01338636 (ClinicalTrials.gov) | September 2008 | 18/4/2011 | An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH) | An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Patients With Exercise Induced Pulmonary Arterial Hypertension | Exercise-induced Pulmonary Arterial Hypertension | Drug: Ambrisentan | Brigham and Women's Hospital | Gilead Sciences | Completed | 18 Years | N/A | All | 30 | Phase 4 | United States |
| 314 | NCT00741819 (ClinicalTrials.gov) | September 2008 | 23/8/2008 | Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects | An Open Label, Multi-center Study Evaluating the Safety of Long-term Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension. | Pulmonary Arterial Hypertension | Drug: Inhaled treprostinil | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 73 | Phase 4 | United States |
| 315 | NCT00709098 (ClinicalTrials.gov) | September 2008 | 1/7/2008 | Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension | A Multicenter, Double-blind, Randomized Study Comparing the Safety and Tolerability of Iloprost Inhalation Solution Delivered by I-neb Utilizing Power Disc-15 and Power Disc-6 in Patients With Symptomatic Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: iloprost | Actelion | NULL | Completed | 18 Years | N/A | All | 49 | Phase 3 | United States;Austria;Germany |
| 316 | NCT00825266 (ClinicalTrials.gov) | September 2008 | 16/1/2009 | Insulin Resistance in Pulmonary Arterial Hypertension | The Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: bosentan;Drug: Pioglitazone | Stanford University | NULL | Terminated | 18 Years | 75 Years | All | 2 | Phase 2 | United States |
| 317 | NCT00742014 (ClinicalTrials.gov) | August 2008 | 25/8/2008 | The Assessment of Right Ventricular Contractility in Response to Sildenafil | The Assessment of Right Ventricular Contractility in Response to Sildenafil in Pediatric Patients With Pulmonary Arterial Hypertension | Hypertension | Drug: Sildenafil | The Hospital for Sick Children | NULL | Terminated | 1 Year | 18 Years | All | 10 | Phase 3 | Canada |
| 318 | EUCTR2007-003621-24-ES (EUCTR) | 07/07/2008 | 12/05/2008 | Estudio doble ciego, aleatorizado, controlado por placebo, de determinación de dosis, de grupos paralelos, para valorar los efectos hemodinámicos, la eficacia clínica, la tolerabilidad y la seguridad de Aviptadil (Péptido intestinal Vasoactivo) tras una inhalación, e inhalaciones repetidas, en pacientes con hipertensión arterial pulmonar. | Estudio doble ciego, aleatorizado, controlado por placebo, de determinación de dosis, de grupos paralelos, para valorar los efectos hemodinámicos, la eficacia clínica, la tolerabilidad y la seguridad de Aviptadil (Péptido intestinal Vasoactivo) tras una inhalación, e inhalaciones repetidas, en pacientes con hipertensión arterial pulmonar. | Hipertensión arterial pulmonar (HAP) debida a hipertensión arterial pulmonar idiopática (HAPI), HAP familiar o HAP asociada con enfermedades del tejido conjuntivo (ETC) (p. ej. esclerosis sistémica, lupus eritematoso sistémico) o con defectos cardiacos congénitos reparados(DCCR). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 319 | NCT00723554 (ClinicalTrials.gov) | July 2008 | 24/7/2008 | Iloprost Power Disc-15 in Pulmonary Arterial Hypertension | A Phase IIIb, Multicenter, Open-label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 (PD-6) to Power Disc-15 (PD-15) With the I-neb® AAD® | Pulmonary Arterial Hypertension | Drug: Iloprost PD-6;Drug: Iloprost PD-15 | Actelion | NULL | Terminated | 18 Years | 85 Years | All | 63 | Phase 3 | United States |
| 320 | NCT00705133 (ClinicalTrials.gov) | July 2008 | 23/6/2008 | Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension | Using Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung Disease | Pulmonary Arterial Hypertension;Interstitial Lung Disease;Idiopathic Pulmonary Fibrosis | Drug: Treprostinil | Rajan Saggar | United Therapeutics | Completed | N/A | N/A | All | 15 | Phase 2 | United States |
| 321 | NCT00709956 (ClinicalTrials.gov) | July 2008 | 1/7/2008 | Iloprost Power 15 in Pulmonary Arterial Hypertension | A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: iloprost (5 µg);Drug: placebo | Actelion | NULL | Completed | 18 Years | N/A | All | 64 | Phase 3 | United States;Austria;Germany |
| 322 | EUCTR2005-005068-97-ES (EUCTR) | 11/05/2008 | 03/03/2008 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 | Hipertensión Arterial PulmonarPatients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Portugal;Czech Republic;Slovakia;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 323 | NCT00660179 (ClinicalTrials.gov) | May 2008 | 14/4/2008 | Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: macitentan (ACT-064992);Drug: placebo | Actelion | NULL | Completed | 12 Years | N/A | All | 742 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Norway;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Finland;Former Serbia and Montenegro;Portugal |
| 324 | NCT00430716 (ClinicalTrials.gov) | April 8, 2008 | 31/1/2007 | To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension. | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension | Drug: Sildenafil citrate | Pfizer | NULL | Terminated | 18 Years | N/A | All | 130 | Phase 4 | United States;Belgium;Brazil;Bulgaria;China;Greece;India;Italy;Latvia;Malaysia;Netherlands;Philippines;Poland;Romania;Russian Federation;Thailand;United Kingdom;Denmark;Panama |
| 325 | NCT00617305 (ClinicalTrials.gov) | April 2008 | 6/2/2008 | Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1) | An Open-label, Multicenter Study of Ambrisentan and a Phosphodiesterase Type-5 Inhibitor Combination Therapy in Subjects With Pulmonary Arterial Hypertension Who Have Demonstrated a Sub-Optimal Response to a Phosphodiesterase Type-5 Inhibitor | Pulmonary Arterial Hypertension | Drug: Ambrisentan;Drug: Placebo;Drug: Sildenafil;Drug: Tadalafil | Gilead Sciences | NULL | Completed | 16 Years | 75 Years | All | 38 | Phase 4 | United States |
| 326 | NCT00643604 (ClinicalTrials.gov) | March 2008 | 20/3/2008 | Rapid Switch From Flolan to Remodulin in the Outpatient Clinic | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment Satisfaction | Hypertension, Pulmonary | Drug: treprostinil sodium | United Therapeutics | NULL | Terminated | 18 Years | 70 Years | All | 7 | Phase 4 | United States |
| 327 | NCT00554619 (ClinicalTrials.gov) | February 2008 | 5/11/2007 | A Study to Evaluate GSK1325760A - a Long-Term Extension Study | Study AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study - | Pulmonary Arterial Hypertension;Hypertension, Pulmonary | Drug: GSK1325760A | GlaxoSmithKline | NULL | Completed | N/A | N/A | All | 21 | Phase 3 | Japan |
| 328 | NCT00625469 (ClinicalTrials.gov) | October 2007 | 19/2/2008 | Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan | Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study | Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis | Drug: bosentan | Rajan Saggar | Actelion | Withdrawn | N/A | N/A | All | 0 | Phase 4 | United States |
| 329 | NCT00540436 (ClinicalTrials.gov) | August 2007 | 5/10/2007 | Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension | Study AMB107816, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open-Label Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A - | Hypertension, Pulmonary | Drug: GSK1325760A | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 25 | Phase 2 | Japan |
| 330 | EUCTR2006-000800-17-ES (EUCTR) | 29/05/2007 | 02/03/2010 | Estudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Estudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | HAP idiopática o familiar incluyendo HAP asociada a:1) Uso de un inhibidor del apetito2) Corticircuito sistémico-pulmonar congénito corregido (corrección = 5 años)3) HAP asociada a enfermedad del tejido conjuntivo vascular4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Dietanolamina de treprostinilo Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 331 | NCT00454207 (ClinicalTrials.gov) | April 2007 | 28/3/2007 | Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension | A Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: sildenafil citrate (UK-92,480) | Pfizer | NULL | Completed | 16 Years | N/A | All | 44 | Phase 3 | Japan |
| 332 | NCT00433329 (ClinicalTrials.gov) | March 2007 | 7/2/2007 | Combination Therapy in Pulmonary Arterial Hypertension | COMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac Remodeling | Pulmonary Arterial Hypertension | Drug: Bosentan;Drug: Sildenafil | Actelion | NULL | Completed | 12 Years | N/A | All | 100 | Phase 4 | United States |
| 333 | NCT00625079 (ClinicalTrials.gov) | February 2007 | 19/2/2008 | Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil | Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study | Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease;Pulmonary Hypertension | Drug: sildenafil | University of California, Los Angeles | Pfizer | Withdrawn | N/A | N/A | All | 0 | Phase 4 | United States |
| 334 | NCT00439946 (ClinicalTrials.gov) | February 2007 | 22/2/2007 | Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment Satisfaction | Pulmonary Arterial Hypertension | Drug: treprostinil;Device: Crono Five ambulatory pump | United Therapeutics | NULL | Terminated | 18 Years | 65 Years | All | 8 | Phase 4 | United States |
| 335 | NCT00325442 (ClinicalTrials.gov) | October 2006 | 11/5/2006 | FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH) | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Oral treprostinil (UT-15C) sustained release tablets;Drug: Placebo | United Therapeutics | NULL | Completed | 12 Years | 70 Years | All | 354 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Spain;United Kingdom |
| 336 | NCT00325403 (ClinicalTrials.gov) | October 2006 | 11/5/2006 | FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH) | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Oral treprostinil (UT-15C) Sustained Release Tablets;Other: Placebo | United Therapeutics | NULL | Completed | 12 Years | 75 Years | All | 349 | Phase 3 | United States;Austria;Belgium;Canada;China;France;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico |
| 337 | NCT00384865 (ClinicalTrials.gov) | September 2006 | 30/9/2006 | A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension | A Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Simvastatin;Drug: Aspirin;Drug: Placebo | University of Pennsylvania | National Heart, Lung, and Blood Institute (NHLBI) | Terminated | 18 Years | N/A | All | 64 | Phase 2 | United States |
| 338 | NCT00323297 (ClinicalTrials.gov) | September 2006 | 5/5/2006 | Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension | A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah) | Pulmonary Arterial Hypertension | Drug: Bosentan;Other: Placebo;Drug: Sildenafil Citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | N/A | All | 105 | Phase 4 | United States;Australia;Czechia;France;Germany;Greece;Israel;Italy;Taiwan;United Kingdom;Belgium;Czech Republic |
| 339 | NCT00373360 (ClinicalTrials.gov) | September 2006 | 7/9/2006 | Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction | Pulmonary Hypertension | Drug: treprostinil sodium | United Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 10 | Phase 4 | United States |
| 340 | EUCTR2005-005066-37-DE (EUCTR) | 09/06/2006 | 06/11/2006 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks. | Product Name: sildenafil Product Code: N/A INN or Proposed INN: Sildenafil citrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | United Kingdom;Germany;Italy | ||
| 341 | EUCTR2005-006192-13-ES (EUCTR) | 09/06/2006 | 12/05/2006 | Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION | Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION | Spanish: hipertensión arterial pulmonar English: Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Classification code 10037400 | Trade Name: **Comment**- IMP inhalation solution identical to ventavis inhalation solution, but IMP is in a different volume presentation. Please see covering letter. Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost | CoTherix, Inc | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Portugal;Spain;Austria;Germany;Italy;United Kingdom | ||
| 342 | NCT00946114 (ClinicalTrials.gov) | June 2006 | 22/7/2009 | To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks | A Local, Multi-Centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For One Hundred Twelve Weeks / Prior To Reimbursement And Availability For Patients In Poland. | Pulmonary Hypertension | Drug: sildenafil | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | N/A | All | 32 | Poland | |
| 343 | NCT01027949 (ClinicalTrials.gov) | May 2006 | 4/12/2009 | An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension | An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine | United Therapeutics | NULL | Active, not recruiting | 12 Years | N/A | All | 900 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;India;Ireland;Israel;Italy;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Spain;Sweden;United Kingdom;Czech Republic |
| 344 | NCT00303459 (ClinicalTrials.gov) | May 2006 | 16/3/2006 | Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH) | Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study | Pulmonary Arterial Hypertension | Drug: bosentan;Drug: placebo | Actelion | NULL | Completed | 12 Years | N/A | All | 334 | Phase 4 | United States;Brazil;Czech Republic;Denmark;Germany;Greece;Portugal;Saudi Arabia;Slovakia;Spain;Sweden;United Kingdom |
| 345 | EUCTR2005-005066-37-BE (EUCTR) | 21/04/2006 | 15/02/2006 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks. | Trade Name: viagra Product Name: sildenafil Product Code: N/A INN or Proposed INN: Sildenafil citrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | Belgium;Germany;Italy;United Kingdom | ||
| 346 | NCT01721564 (ClinicalTrials.gov) | April 2006 | 1/11/2012 | Bosentan and Pulmonary Endothelial Function | Pulmonary Artery Remodelling With Bosentan | Pulmonary Arterial Hypertension | Drug: Bosentan | Prof David S Celermajer | NULL | Completed | 18 Years | 80 Years | All | 8 | N/A | NULL |
| 347 | NCT00477269 (ClinicalTrials.gov) | April 2006 | 22/5/2007 | Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Six Months Treatment With the Tyrosine Kinase Inhibitor STI571 for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Imatinib mesylate;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 59 | Phase 2/Phase 3 | United States;Austria;Germany;United Kingdom |
| 348 | EUCTR2005-005066-37-GB (EUCTR) | 15/03/2006 | 13/02/2006 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxins Patients are already on prescribed bosentan therapy for at least 12 weeks. | Trade Name: viagra Product Name: sildenafil Product Code: N/A INN or Proposed INN: Sildenafil citrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 44 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Germany;Italy;United Kingdom | ||
| 349 | EUCTR2005-002692-33-ES (EUCTR) | 02/02/2006 | 12/12/2005 | Estudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | Estudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerte | Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil | Lilly ICOS LLC | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Belgium;Spain;Ireland;Germany;Italy;United Kingdom | ||
| 350 | NCT00302211 (ClinicalTrials.gov) | February 1, 2006 | 10/3/2006 | The VISION Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension | A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral Sildenafil | Pulmonary Hypertension | Drug: Inhaled Iloprost (5 µg);Drug: Inhaled Placebo;Drug: Sildenafil;Drug: Bosentan | Actelion | NULL | Terminated | 12 Years | 85 Years | All | 67 | Phase 3 | United States |
| 351 | NCT00549302 (ClinicalTrials.gov) | December 2005 | 23/10/2007 | Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs | An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: tadalafil | Eli Lilly and Company | ICOS Corporation | Completed | 12 Years | N/A | All | 357 | Phase 3 | United States;Belgium;Canada;France;Germany;Ireland;Italy;Japan;Spain;United Kingdom |
| 352 | NCT00319020 (ClinicalTrials.gov) | August 23, 2005 | 26/4/2006 | Bosentan in Children With Pulmonary Arterial Hypertension Extension Study | An Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed FUTURE 1 | Pulmonary Arterial Hypertension | Drug: Bosentan | Actelion | NULL | Completed | 2 Years | 11 Years | All | 33 | Phase 3 | United States;France;Germany;Italy;Netherlands;Switzerland;United Kingdom |
| 353 | NCT00593905 (ClinicalTrials.gov) | July 2005 | 3/1/2008 | Pharmacogenomics in Pulmonary Arterial Hypertension | Pharmacogenomics in Pulmonary Arterial Hypertension: A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific Genes | Pulmonary Arterial Hypertension;Pulmonary Hypertension;PAH WHO Group I | Drug: Sitaxsentan;Drug: Bosentan, Ambrisentan | West Penn Allegheny Health System | National Institutes of Health (NIH);Baylor College of Medicine;Emory University;University of Chicago;Johns Hopkins University;Tufts Medical Center;Sir Mortimer B. Davis - Jewish General Hospital;London Health Sciences Centre;University of Maryland, College Park;University of California, San Francisco;University of Calgary;Chest Medical Associates;Columbia University;Lung Diagnostics, Ltd.;Duke University;University of California, Los Angeles;Latter Day Saints Hospital;Louisiana State University Health Sciences Center in New Orleans;Massachusetts General Hospital;Mayo Clinic;Medical College of Wisconsin;Southeastern Lung Care;Suncoast Lung Center;Children's Hospital Colorado;University Hospitals Cleveland Medical Center;University of Colorado, Denver;University of Michigan;University of Pittsburgh Medical Center;University of Southern California;The University of Texas Medical Branch, Galveston;Vanderbilt University;Wayne State University;Ohio State University;University of Alabama at Birmingham;Washington University School of Medicine;Sentara Norfolk General Hospital;University of Texas Southwestern Medical Center;Bay Area Chest Physicians | Withdrawn | N/A | N/A | All | 0 | United States | |
| 354 | NCT03055221 (ClinicalTrials.gov) | June 10, 2005 | 9/2/2017 | TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH) | TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Intravenous Treprostinil | United Therapeutics | NULL | Completed | 16 Years | 75 Years | All | 20 | Phase 4 | NULL |
| 355 | NCT00147199 (ClinicalTrials.gov) | June 2005 | 2/9/2005 | Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH) | TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Inhaled treprostinil;Drug: Placebo inhalation solution | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 235 | Phase 3 | United States;Austria;Belgium;France;Germany;Ireland;Israel;Italy;Spain;United Kingdom |
| 356 | NCT00423592 (ClinicalTrials.gov) | May 2005 | 17/1/2007 | Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension | A Phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects With Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities | Pulmonary Hypertension | Drug: ambrisentan | Gilead Sciences | NULL | Completed | 12 Years | 75 Years | All | 36 | Phase 2 | NULL |
| 357 | NCT00626028 (ClinicalTrials.gov) | September 2004 | 20/2/2008 | Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing | Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing | Idiopathic Pulmonary Arterial Hypertension;Cardiomyopathy | Drug: Nitric Oxide for inhalation;Drug: Oxygen;Drug: Nitric Oxide plus Oxygen | Mallinckrodt | NULL | Completed | N/A | 18 Years | All | 136 | Phase 3 | United States;France;Netherlands;Spain;United Kingdom |
| 358 | NCT00578786 (ClinicalTrials.gov) | February 2004 | 19/12/2007 | A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202) | A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202) | Pulmonary Arterial Hypertension | Drug: ambrisentan | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 383 | Phase 3 | Argentina;Brazil;Chile;Mexico |
| 359 | NCT00367770 (ClinicalTrials.gov) | January 2004 | 21/8/2006 | BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | Pulmonary Arterial Hypertension | Drug: Tracleer® | Actelion | NULL | Completed | 12 Years | N/A | All | 37 | Phase 4 | United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 360 | NCT00159874 (ClinicalTrials.gov) | January 2004 | 8/9/2005 | A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131 | Pulmonary Arterial Hypertension | Drug: Sildenafil citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 1 Year | 17 Years | All | 234 | Phase 3 | United States;Brazil;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;Sweden;Taiwan;Canada;Costa Rica;Panama;Singapore |
| 361 | NCT00159913 (ClinicalTrials.gov) | August 2003 | 8/9/2005 | A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension. | A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension. | Pulmonary Arterial Hypertension, Children | Drug: Sildenafil citrate;Drug: Placebo | Pfizer | NULL | Completed | 1 Year | 17 Years | All | 235 | Phase 3 | United States;Brazil;Canada;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Peru;Poland;Russian Federation;Sweden;Taiwan;Australia;Costa Rica;Panama;Singapore |
| 362 | NCT00159861 (ClinicalTrials.gov) | July 2003 | 8/9/2005 | The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH | A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension. | Pulmonary Hypertension | Drug: Sildenafil citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Pfizer | Completed | 16 Years | N/A | All | 267 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Israel;Italy;Netherlands;Spain;United Kingdom;Czech Republic |
| 363 | NCT00424021 (ClinicalTrials.gov) | April 2003 | 17/1/2007 | Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension | An Open-Label, Long-Term Study of Ambrisentan in Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220 | Pulmonary Hypertension | Drug: ambrisentan | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 54 | Phase 2 | NULL |
| 364 | NCT00811018 (ClinicalTrials.gov) | March 2003 | 9/12/2008 | A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension | A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Sitaxsentan | Pfizer | NULL | Terminated | 12 Years | 75 Years | All | 1192 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Spain;United Kingdom |
| 365 | NCT00159887 (ClinicalTrials.gov) | December 2002 | 8/9/2005 | Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension | A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140. | Pulmonary Hypertension | Drug: Sildenafil citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | N/A | All | 260 | Phase 3 | United States;Australia;Belgium;Brazil;Czechia;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Singapore;South Africa;Spain;Sweden;United Kingdom;Czech Republic |
| 366 | NCT00644605 (ClinicalTrials.gov) | October 2002 | 20/3/2008 | A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension | A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over | Hypertension, Pulmonary | Drug: sildenafil;Drug: placebo | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | N/A | All | 275 | Phase 3 | United States;Australia;Belgium;Brazil;Czechia;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Singapore;South Africa;Spain;Sweden;United Kingdom;Czech Republic |