| Tracleer (bosentan) / J&J, Roche |
2011-004106-16: A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound |
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| Completed | 3 | 105 | Europe, RoW | bosentan, Dispersible tablet, Tracleer | Actelion pharmaceuticals Ltd, Actelion Pharmaceuticals Ltd. | Pulmonary arterial hypertension (PAH) in children, PAH is a deadly disease that causes narrowing of the pulmonary artery, which requires more effort from the heart to pump blood into the lungs, eventually leading to right heart failure., Diseases [C] - Cardiovascular Diseases [C14] | | | | |
NCT00080457: Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension |
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| Completed | 3 | 240 | US | sitaxsentan sodium | Encysive Pharmaceuticals | Pulmonary Hypertension | | 01/05 | | |
| Completed | 3 | 185 | US, Canada, Europe, RoW | bosentan, Tracleer, placebo | Actelion | Pulmonary Hypertension | 11/06 | 02/11 | | |
| Completed | 3 | 36 | US, Europe | Bosentan, ACT-050088, Ro 47-0203 | Actelion | Pulmonary Arterial Hypertension | 12/06 | 02/07 | | |
| Completed | 3 | 157 | US, Canada, Europe, RoW | bosentan | Actelion | Chronic Thromboembolic Pulmonary Hypertension | 02/07 | 03/07 | | |
NCT00310830: Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients With Pulmonary Arterial Hypertension (PAH) |
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| Terminated | 3 | 14 | US, Europe | Bosentan | Actelion | Pulmonary Hypertension | 08/07 | 08/07 | | |
| Terminated | 3 | 236 | US, Europe | Bosentan | Actelion, National Heart, Lung, and Blood Institute (NHLBI) | Pulmonary Hypertension, Sickle Cell Anemia | 08/07 | 12/07 | | |
ASSET-2, NCT00313196: Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients Diagnosed With Pulmonary Hypertension (PH) |
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| Terminated | 3 | 12 | US, Europe | bosentan | Actelion | Pulmonary Hypertension | 08/07 | 08/07 | | |
| Terminated | 3 | 67 | US | Inhaled Iloprost (5 μg), Inhaled Placebo, Sildenafil, Bosentan | Actelion | Pulmonary Hypertension | 12/07 | 07/08 | | |
| Completed | 3 | 151 | US, Canada, Europe, RoW | bosentan | Actelion | Pulmonary Hypertension | 02/09 | 04/09 | | |
NCT00780728: Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial Hypertension |
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| Withdrawn | 3 | | Canada | Sildenafil | University Health Network, Toronto | Hypertension, Pulmonary | | | | |
NCT00864201: A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease |
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| Unknown status | 3 | 10 | Canada | bosentan | Hamilton Health Sciences Corporation, Actelion | Hypertension, Pulmonary, Connective Tissue Disease | 04/10 | 04/10 | | |
| Completed | 3 | 33 | US, Europe | Bosentan, Ro 47-0203, Tracleer | Actelion | Pulmonary Arterial Hypertension | 10/11 | 10/11 | | |
2011-004612-31: A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time. |
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| Completed | 3 | 105 | Europe | bosentan, Dispersible tablet, Tracleer | Actelion pharmaceuticals Ltd, Actelion Pharmaceuticals Ltd. | Pulmonary arterial hypertension (PAH) in children, PAH is a deadly disease that causes narrowing of the pulmonary artery, which requires more effort from the heart to pump blood into the lungs, eventually leading to right heart failure., Diseases [C] - Cardiovascular Diseases [C14] | | | | |
| Completed | 3 | 21 | Europe, US, RoW | Imatinib, QTI571, Sildenafil, Bosentan | Novartis Pharmaceuticals | Pulmonary Arterial Hypertension | 10/12 | 10/12 | | |
| Completed | 3 | 64 | US, Europe, RoW | bosentan, Tracleer, ACT-050088 | Actelion | Pulmonary Arterial Hypertension | 04/13 | 08/13 | | |
| Terminated | 3 | 23 | US, Europe, RoW | Bosentan, Tracleer, Matching placebo | Actelion | Persistent Pulmonary Hypertension of the Newborn | 12/13 | 01/14 | | |
| Completed | 3 | 20 | Europe | bosentan, Ro 47.0203, placebo | University Teaching Hospital Hall in Tirol | Heart Failure, Diastolic, Hypertension, Pulmonary | 06/14 | 06/14 | | |
| Completed | 3 | 58 | Europe, US, RoW | Bosentan, ACT-050088 | Actelion | Pulmonary Arterial Hypertension | 08/14 | 05/20 | | |
BIPH, NCT01712997: Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients |
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| Unknown status | 3 | 90 | RoW | Iloprost, Bosentan | Air Force Military Medical University, China | Pulmonary Arterial Hypertension | 09/14 | | | |
2012-001829-27: The Extension of the research project FUTURE 4 to find out whether patients with persistent pulmonary hypertension of the newborn (PPHN) who received bosentan in addition to inhaled nitric oxide grow normally and to study whether they have late side effects. |
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| Completed | 3 | 30 | Europe | | Actelion Pharmaceuticals Ltd., Actelion Pharmaceuticals Ltd. | Persistent Pulmonary Hypertension of the Newborn (PPHN), PPHN is a rare and life threatening disease causing severe breathing difficulties in babies which can lead to suffocation and death., Diseases [C] - Cardiovascular Diseases [C14] | | | | |
2004-000478-30: Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. |
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| | 3 | 31 | Europe | bosentan, Ro 47-0203, Tracleer, Tracleer | Actelion Pharmaceuticals Ltd., Actelion Pharmaceuticals Ltd | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.There are no approved drug therapies for Class II PAH and the EARLY study is the first trial designed to enroll exclusively class II patients. | | 02/11 | | |
2009-017155-10: Evaluation of tolerability and efficacy of the combination Sildenafil/Bosentan in patients with severe pulmonary hypertension. Valutazione dell`efficacia e della tollerabilita` della terapia combinata Bosentan-Sildenafil in pazienti con ipertensione polmonare severa. |
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| Completed | 3 | 60 | Europe | VIAGRA, TRACLEER, VIAGRA, TRACLEER | CASA DI CURA PRIVATA S.RAFFAELE - PISANA | severe pulmonary hypertension ipertensione polmonare severa | | | | |
MoD, NCT04039464: Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension |
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| Recruiting | 3 | 100 | Canada, US | Mono-Therapy with Sildenafil, Revatio monotherapy, Duo-Therapy with Sildenafil + Bosentan, Dual therapy with Revatio and Tracleer | Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), National Center for Advancing Translational Sciences (NCATS) | Pediatric Pulmonary Hypertension | 09/26 | 09/26 | | |
BOSAPAH, NCT00581607: Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension |
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| Completed | 2/3 | 43 | US | Bosentan, Tracleer, Placebo, tracleer | University of Cincinnati, Actelion | Sarcoidosis, Pulmonary Arterial Hypertension | 10/12 | 12/12 | | |
ERAATH, NCT01352065: Characterization and Detection of Prolonged Endothelin Receptors Antagonists Administration |
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| Completed | 2/3 | 30 | RoW | Bosentan, Ambrisentan, Placebo | Center for Health, Exercise and Sport Sciences, Serbia | Pulmonary Hypertension | 12/12 | 05/13 | | |
