86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details
臨床試験数 : 1,181 / 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192
| 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 | 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 | Recruiting | 16years-old | Not applicable | Male and Female | 33 | Not selected | Japan |
| 2 | EUCTR2016-003495-53-NL (EUCTR) | 29/11/2016 | 15/12/2016 | Study on the effect of the drug selexipag in adult patients with elevated pressure in the pulmonary arteries due to a cardiac birth defect | Prostacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease - SELECT trial | Pulmonary arterial hypertension related to congenital heart disease.;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Selexipag Product Name: Selexipag | Academic Medical Center - Cardiology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 3 | NCT02436512 (ClinicalTrials.gov) | June 2015 | 13/4/2015 | Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide | A Phase 3 Open-label Multi-Center, Two-Part Single-arm Study to Evaluate the Acute Vasodilation Response of Inhaled Nitric Oxide as a Predictor of Successful Wean From Parental Prostacyclins in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Inhaled Nitric Oxide | Geno LLC | NULL | Withdrawn | 18 Years | 70 Years | Both | 0 | Phase 3 | United States |
| 4 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | EUCTR2009-012450-20-FR (EUCTR) | 15/10/2009 | 07/09/2009 | 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 | 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 MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: Tezosentan Product Code: ACT-050089 (Ro 61-0612) INN or Proposed INN: tezosentan Other descriptive name: Tezosentan | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 13 | Phase 2 | France | ||
| 9 | 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 |