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| Sponsor: | Actelion |
|---|---|
| Information provided by: | Actelion |
| ClinicalTrials.gov Identifier: | NCT00313222 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 31 Study Locations
More Information
| Responsible Party: | Sebastien Roux, MD, Actelion |
| ClinicalTrials.gov Identifier: | NCT00313222 History of Changes |
| Other Study ID Numbers: | AC-052-366 |
| Study First Received: | April 10, 2006 |
| Last Updated: | February 11, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
CTEPH bosentan |
|
Hypertension Hypertension, Pulmonary Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
Bosentan Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |