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 | 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 |
| 2 | 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 |
| 3 | 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 |
| 4 | 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 |
| 5 | NCT01458236 (ClinicalTrials.gov) | November 2011 | 29/9/2011 | A Multinational, Multicenter, Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor | A Multinational, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium 314d Modified Release Tablets;Drug: Placebo | Lung Biotechnology Inc. | NULL | Withdrawn | 18 Years | 80 Years | Both | 0 | Phase 3 | NULL |
| 6 | EUCTR2009-014453-32-CZ (EUCTR) | 15/07/2010 | 11/02/2010 | NA | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | Pulmonary Arterial Hypertension MedDRA version: 14.1;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: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung LLC | NULL | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Belgium;Ireland;Germany | |||
| 7 | EUCTR2009-014246-29-DE (EUCTR) | 08/04/2010 | 16/11/2009 | 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) | 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 MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium | Lung Rx | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Czech Republic;Belgium;Ireland;Germany | ||
| 8 | EUCTR2009-014246-29-CZ (EUCTR) | 18/02/2010 | 07/12/2009 | 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) | 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 MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung Rx Inc | NULL | Not Recruiting | Female: yes Male: yes | 36 | Germany;Czech Republic;Belgium;Ireland | |||
| 9 | EUCTR2009-014246-29-IE (EUCTR) | 01/02/2010 | 06/11/2009 | 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) | 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 MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium | Lung Rx | NULL | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Germany;Belgium;Ireland | |||
| 10 | 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 |
| 11 | EUCTR2009-014453-32-IE (EUCTR) | 01/02/2010 | 09/11/2009 | An open-label 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 MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung LLC Inc | NULL | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Belgium;Ireland;Germany | |||
| 12 | EUCTR2009-014453-32-BE (EUCTR) | 11/01/2010 | 09/11/2009 | An open-label 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 MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung LLC | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | United States;Czech Republic;Belgium;Ireland;Romania;Germany | ||
| 13 | EUCTR2009-014246-29-BE (EUCTR) | 09/12/2009 | 09/11/2009 | 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) | 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 MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung Rx Inc | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Czech Republic;Belgium;Ireland;Germany | ||
| 14 | 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 |
| 15 | EUCTR2008-003290-41-IE (EUCTR) | 29/06/2009 | 11/12/2008 | 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 MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | LungRx | NULL | Not Recruiting | Female: yes Male: yes | 10 | Belgium;Ireland | |||
| 16 | EUCTR2008-006833-29-IE (EUCTR) | 29/06/2009 | 11/12/2008 | 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 MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung LLC | NULL | Not Recruiting | Female: yes Male: yes | 19 | Belgium;Ireland | |||
| 17 | ChiCTR-TCC-12002776 | 2009-05-01 | 2012-10-23 | BEraproST combined therapy with Sildenafil for pulmonary arterial hypertension | BEraproST combined therapy with Sildenafil for pulmonary arterial hypertension | Pulmonary arterial hypertension | Group B :beraprost combined with sildenafil ;A:Sildenafil citrate ; | Shanghai Pulmonary Hospital | NULL | Completed | 18 | 65 | Both | Group B :30;A:30; | China | |
| 18 | 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 |
| 19 | EUCTR2008-003290-41-BE (EUCTR) | 04/02/2009 | 09/12/2008 | 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 MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung Rx | NULL | Not Recruiting | Female: yes Male: yes | 20 | Belgium;Ireland | |||
| 20 | EUCTR2008-006833-29-BE (EUCTR) | 04/02/2009 | 16/12/2008 | 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 MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung LLC | NULL | Not Recruiting | Female: yes Male: yes | 19 | Phase 2 | United States;Belgium;Ireland | ||
| 21 | 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 |
| 22 | JPRN-UMIN000001350 | 2008/09/01 | 01/10/2008 | Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases | Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases - Keio university clinical trial for early pulmonary arterial hypertension with connective tissue diseases (KEEP-ACTIVE study) | Pulmonary arterial hypertension (PAH) associated with connective tissue disease | Beraprost sodium Beraprost sodium and Sildenafil citrate | Keio University | NULL | Complete: follow-up complete | 18years-old | 80years-old | Male and Female | 70 | Not selected | Japan |
| 23 | EUCTR2009-014453-32-DE (EUCTR) | 11/12/2009 | An open-label 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 MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP | Lung RX | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Czech Republic;Belgium;Ireland;Germany |