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Last Updated: August 13, 2022

CLINICAL TRIALS PROFILE FOR BOSENTAN


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All Clinical Trials for Bosentan

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00023296 ↗ Nitric Oxide and Transfusion Therapy for Sickle Cell Patients With Pulmonary Hypertension Completed Mallinckrodt Phase 1 2001-07-27 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 2001-07-27 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 2003-07-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bosentan

Condition Name

Condition Name for Bosentan
Intervention Trials
Pulmonary Arterial Hypertension 29
Pulmonary Hypertension 24
Hypertension, Pulmonary 8
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Condition MeSH

Condition MeSH for Bosentan
Intervention Trials
Hypertension 69
Pulmonary Arterial Hypertension 46
Familial Primary Pulmonary Hypertension 43
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Clinical Trial Locations for Bosentan

Trials by Country

Trials by Country for Bosentan
Location Trials
United States 399
Germany 40
Canada 36
France 31
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 35
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Bosentan
Clinical Trial Phase Trials
Completed 76
Terminated 21
Unknown status 17
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Clinical Trial Sponsors for Bosentan

Sponsor Name

Sponsor Name for Bosentan
Sponsor Trials
Actelion 50
University of California, Los Angeles 5
Johns Hopkins University 4
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Sponsor Type

Sponsor Type for Bosentan
Sponsor Trials
Other 150
Industry 78
NIH 7
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