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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00313222 |
The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i) peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary hypertension after pulmonary endarterectomy.
Condition | Intervention | Phase |
---|---|---|
Chronic Thromboembolic Pulmonary Hypertension |
Drug: bosentan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) |
Enrollment: | 157 |
Study Start Date: | October 2005 |
Study Completion Date: | March 2007 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Actelion ( Sebastien Roux, MD ) |
Study ID Numbers: | AC-052-366 |
Study First Received: | April 10, 2006 |
Last Updated: | December 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00313222 |
Health Authority: | United States: Food and Drug Administration |
CTEPH bosentan |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Vascular Diseases Bosentan Hypertension |
Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |