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| Not yet recruiting | 4 | 15 | | | Actelion Phrmaceuticals Australia, Actelion Phrmaceuticals Australia | Hypertension, Pulmonary | | | | |
NCT00317486: Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology |
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| Completed | 4 | 54 | US, Canada, Europe, RoW | bosentan | Actelion | Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | 04/05 | 04/05 | | |
NCT00367770: BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology |
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| Completed | 4 | 37 | US, Canada, Europe, RoW | Tracleer® | Actelion | Pulmonary Arterial Hypertension | 12/05 | 12/05 | | |
NCT00120380: Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH) |
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| Terminated | 4 | 40 | Europe | Aerosolized iloprost, Placebo | Hannover Medical School | Hypertension | 05/06 | 05/06 | | |
2006-003133-33: Etude des effets d’un antagoniste non spécifique de l’endothéline (le bosentan) sur l’activité orthosympathique et le chémoréflexe. |
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| Ongoing | 4 | 20 | Europe | Tablet, Tracleer | Hôpital Erasme | healthy subjectsobstructive sleep apnea(Bosentan is used in clinic in pulmonary hypertension) | | | | |
| Completed | 4 | 22 | US, Europe, RoW | bosentan, Tracleer (R) | Actelion | Hypertension, Pulmonary | 02/07 | 11/07 | | |
NCT00266162: Bosentan in Treatment of Pulmonary Arterial Hypertension |
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| Completed | 4 | 60 | Europe | Bosentan administration | Competence Network for Congenital Heart Defects, German Federal Ministry of Education and Research, Actelion | Eisenmenger Syndrome | 02/08 | 02/08 | | |
| Completed | 4 | 11 | RoW | bosentan, Tracleer | Actelion | Hypertension, Pulmonary | 12/08 | 06/10 | | |
NCT00625469: Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan |
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| Withdrawn | 4 | 0 | US | bosentan, tracleer | Rajan Saggar, Actelion | Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis | 06/09 | 12/09 | | |
| Unknown status | 4 | 48 | Europe | Bosentan, Tracleer, Placebo, Placebo tablets | Royal Brompton & Harefield NHS Foundation Trust, Actelion | Pulmonary Hypertension, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Nonspecific Interstitial Pneumonia | 04/10 | 08/10 | | |
| Completed | 4 | 100 | US | Bosentan, Sildenafil | Actelion | Pulmonary Arterial Hypertension | 05/10 | 08/10 | | |
| Completed | 4 | 32 | US | ambrisentan, Letairis | University of Alabama at Birmingham | Pulmonary Arterial Hypertension | 06/12 | 06/12 | | |
| Terminated | 4 | 4 | Europe | Bosentan | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Pulmonary Hypertension | 12/12 | 06/13 | | |
ChiCTR-ONC-11001799: A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease |
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| Completed | 4 | 50 | | Bosentan therapy | Beijing Anzhen Hospital; Beijing Anzhen Hospital, Actelion Pharmaceuticals Ltd | pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease | | | | |
NCT01449253: Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia |
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| Unknown status | 4 | 60 | RoW | Sildenafil, Bosentan | All India Institute of Medical Sciences, New Delhi | Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia | 07/13 | 07/13 | | |
NCT00323297 / 2006-001464-23: Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension |
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| Completed | 4 | 105 | Europe, US, RoW | Bosentan, Placebo, Sildenafil Citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Pulmonary Arterial Hypertension | 08/13 | 08/13 | | |
| Completed | 4 | 334 | US, Europe, RoW | bosentan, placebo | Actelion | Pulmonary Arterial Hypertension | 12/13 | 12/13 | | |
NCT01508780: Combined Use of Angiography, Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan |
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| Withdrawn | 4 | 0 | US | St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT), Boston Scientific Intravascular Ultrasound | Massachusetts General Hospital, Actelion | Pulmonary Arterial Hypertension | 02/14 | 02/14 | | |
2004-000745-37: Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) |
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| | 4 | 5 | Europe | bosentan, Ro 47-0203, Tracleer, Tracleer | Actelion Pharmaceuticals Ltd., ACTELION PHARMACEUTICALS ITALIA | Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis | | 09/06 | | |
2005-005066-37: 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 |
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| | 4 | 15 | Europe | sildenafil, N/A, viagra, viagra | Actelion Pharmaceuticals Ltd., Actelion Pharmaceuticals Ltd | 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. | | 11/06 | | |
2006-005361-19: Evaluation of the efficacy of the dual endothelin 1 receptor antagonist Bosentan in the treatment of Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and in the treatment of Pulmonary Hypertension secondary to sarcoidosis |
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| Ongoing | 4 | 45 | Europe | tracleer, Tracleer, Tracleer | St Georges Hospital | Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and secondary to SarcoidPatients devolop pulmonary hypertension for various reasons, two common causes are Chronic Obstructive Pulmonary disease and Sarcoid. Once developed it may go on to cause right heart failure and severe breathlessness and eventually death.We believe that the use of bosentan may lower the pulmonary hypertension and improve symptoms. | | | | |
2007-001645-17: Prevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy |
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| Completed | 4 | 60 | Europe | Tracleer, Tracleer, Tracleer | Royal Brompton and Harefield NHS Trust | Pulmonary hypertension in patients with interstitial lung disease. Specifically this trial looks at patients who have mild pulmonary hypertension, or are in an at-risk group to developing pulmonary hypertension, in the context of their interstitial lung disease. The interstitial lung diseases addressed include idiopathic pulmonary fibrosis and non-specific interstitial pneumonitis. | | 11/07 | | |
| Terminated | 4 | 3 | US | Ambrisentan, Letairis | Medical University of South Carolina, Ochsner Health System | Pulmonary Arterial Hypertension | 07/17 | 07/17 | | |
| Unknown status | 4 | 30 | Europe | ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan) | Amsterdam UMC, location VUmc | Pulmonary Arterial Hypertension | 09/17 | 09/17 | | |
BosSilSS, NCT03053739: To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis |
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| Unknown status | 4 | 50 | RoW | Sildenafil 20mg and Bosentan 62.5mg, Sildenafil 20mg and Placebo | Postgraduate Institute of Medical Education and Research | Associated Pulmonary Arterial Hypertension | 12/17 | 12/17 | | |
NCT03229694: the Effect of Tracleer on Tourniquet-associated Hypertension |
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| Unknown status | 4 | 80 | RoW | Tracleer 125Mg Tablet, Bosentan, endothelin receptor antagonist, Placebo | Xuzhou Medical University | Tourniquets, Hypertension, Bosentan | 04/18 | 05/18 | | |
