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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR BOSENTAN

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Clinical Trials for Bosentan

Trial ID Title Status Sponsor Phase Summary
NCT00023296 Nitric Oxide and Transfusion Therapy for Sickle Cell Patients With Pulmonary Hypertension Completed Mallinckrodt Phase 1 This study will test whether inhaling nitric oxide (NO) gas mixed with room air can improve pulmonary hypertension (high blood pressure in the lungs) in patients with sickle cell anemia. Patients with sickle cell disease 18 years of age or older may be eligible to participate in one or more parts of this three-stage study, as follows: Stage 1 Patients undergo the following tests to determine the cause of their pulmonary hypertension: blood tests; echocardiogram (heart ultrasound); asthma test; oxygen breathing study with measurement of arterial blood oxygen levels; chest X-ray; lung scans; MRI of the heart; 6-minute walk test; night-time oxygen measurement while sleeping; and exercise studies. Stage 2 Patients have a detailed MRI evaluation of the heart and are admitted to the NIH Clinical Center intensive care unit (ICU) for the following test: A plastic tube is placed in a vein in the patient's arm and another tube is placed in a deeper neck or leg vein. A third tube is inserted through the vein into the heart and the lung artery to measure blood pressures in the heart and lungs directly. Following baseline measurements, three medications (inhaled oxygen, infused prostaglandin, and inhaled NO) are delivered for 2 hours each, separated by a 30-minute washout period. A small blood sample is drawn during the NO administration. Patients who cannot be treated with nitric oxide or for whom the treatment does not work may receive monthly exchange transfusions for 3 months. For this procedure, 3 to 5 five units of the patient's blood is removed and replaced with 3 to 5 units that do not have sickle hemoglobin. Some patients who do not respond to NO or exchange transfusions may receive an alternative therapy, such as oxygen, prostacyclin, L-arginine, bosentan or sidenafil. Stage 3 Patients remain in the ICU with catheters in place for another 24 hours. During this time they breathe NO. Lung pressures are measured every 4 hours and blood is drawn every 8 hours. They then stay in the hospital 1 more day for observation. Patients then breathe nitric oxide continuously for 2 months using a tank of gas that delivers the NO through tubes placed in the nose. They may do this at home on an outpatient basis or may remain in the hospital for the 2 months. Patients have an echocardiogram and blood tests every week and do a 6-minute walk test every 2 weeks.
NCT00023296 Nitric Oxide and Transfusion Therapy for Sickle Cell Patients With Pulmonary Hypertension Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 1 This study will test whether inhaling nitric oxide (NO) gas mixed with room air can improve pulmonary hypertension (high blood pressure in the lungs) in patients with sickle cell anemia. Patients with sickle cell disease 18 years of age or older may be eligible to participate in one or more parts of this three-stage study, as follows: Stage 1 Patients undergo the following tests to determine the cause of their pulmonary hypertension: blood tests; echocardiogram (heart ultrasound); asthma test; oxygen breathing study with measurement of arterial blood oxygen levels; chest X-ray; lung scans; MRI of the heart; 6-minute walk test; night-time oxygen measurement while sleeping; and exercise studies. Stage 2 Patients have a detailed MRI evaluation of the heart and are admitted to the NIH Clinical Center intensive care unit (ICU) for the following test: A plastic tube is placed in a vein in the patient's arm and another tube is placed in a deeper neck or leg vein. A third tube is inserted through the vein into the heart and the lung artery to measure blood pressures in the heart and lungs directly. Following baseline measurements, three medications (inhaled oxygen, infused prostaglandin, and inhaled NO) are delivered for 2 hours each, separated by a 30-minute washout period. A small blood sample is drawn during the NO administration. Patients who cannot be treated with nitric oxide or for whom the treatment does not work may receive monthly exchange transfusions for 3 months. For this procedure, 3 to 5 five units of the patient's blood is removed and replaced with 3 to 5 units that do not have sickle hemoglobin. Some patients who do not respond to NO or exchange transfusions may receive an alternative therapy, such as oxygen, prostacyclin, L-arginine, bosentan or sidenafil. Stage 3 Patients remain in the ICU with catheters in place for another 24 hours. During this time they breathe NO. Lung pressures are measured every 4 hours and blood is drawn every 8 hours. They then stay in the hospital 1 more day for observation. Patients then breathe nitric oxide continuously for 2 months using a tank of gas that delivers the NO through tubes placed in the nose. They may do this at home on an outpatient basis or may remain in the hospital for the 2 months. Patients have an echocardiogram and blood tests every week and do a 6-minute walk test every 2 weeks.
NCT00070590 Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma Completed Actelion Phase 2/Phase 3 Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.
NCT00071461 Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis Completed Actelion Phase 2/Phase 3 Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis. Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available. The present trial investigates a possible use of bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a new category of patients suffering from IPF. It was decided to offer Open Label treatment (bosentan) for patients willing to continue in the BUILD 1 study.
NCT00077584 Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma Completed Actelion Phase 3 In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.
NCT00080457 Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension Completed Encysive Pharmaceuticals Phase 3 The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial hypertension (PAH).
NCT00082186 The Effect of Tracleer® on Male Fertility Completed Actelion Phase 4 The objective of the study is to evaluate the effects of chronic TRACLEER® treatment on testicular function via semen analysis in male patients with primary pulmonary arterial hypertension (PAH).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Bosentan

Condition Name

Condition Name for Bosentan
Intervention Trials
Pulmonary Arterial Hypertension 28
Pulmonary Hypertension 25
Hypertension, Pulmonary 8
Systemic Sclerosis 6
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Condition MeSH

Condition MeSH for Bosentan
Intervention Trials
Hypertension 66
Familial Primary Pulmonary Hypertension 43
Hypertension, Pulmonary 40
Scleroderma, Systemic 15
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Clinical Trial Locations for Bosentan

Trials by Country

Trials by Country for Bosentan
Location Trials
United States 396
Germany 38
Canada 35
France 30
Australia 28
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Trials by US State

Trials by US State for Bosentan
Location Trials
California 32
Texas 26
New York 23
Pennsylvania 21
Colorado 21
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Clinical Trial Progress for Bosentan

Clinical Trial Phase

Clinical Trial Phase for Bosentan
Clinical Trial Phase Trials
Phase 4 24
Phase 3 32
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Bosentan
Clinical Trial Phase Trials
Completed 66
Terminated 17
Unknown status 13
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Clinical Trial Sponsors for Bosentan

Sponsor Name

Sponsor Name for Bosentan
Sponsor Trials
Actelion 49
University of California, Los Angeles 6
National Heart, Lung, and Blood Institute (NHLBI) 4
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Sponsor Type

Sponsor Type for Bosentan
Sponsor Trials
Other 129
Industry 71
NIH 6
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