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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00313196 |
The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in Sickle Cell Disease (SCD) patients diagnosed with Pulmonary Hypertension. It consists of 3 phases: screening, treatment and follow-up. During the screening visit, the study doctor will decide if patients meet the study requirements. All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment. Patients will be asked to perform exercise capacity test (walking as far as possible for 6 minutes). Following the baseline visit the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected every month, or more often, if needed. At the end of the study some of the patients will be asked to repeat the right heart catheterization. All patients will repeat an exercise capacity test. After completion of the study, patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug. Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment.
Condition | Intervention | Phase |
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Pulmonary Hypertension |
Drug: bosentan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Hypertension Associated With Sickle Cell Disease |
Estimated Enrollment: | 158 |
Study Start Date: | April 2006 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention | |
2: Experimental |
Drug: bosentan
Oral Initial dose: 62.5 mg b.i.d. for 4 weeks for all patients, maintenance dose: 125 mg
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Screening Criteria:
Inclusion Criteria:
Pulmonary hypertension confirmed by right heart catheterization (RHC) performed at the study site within 3 months of the randomization visit and defined as:
Exclusion Criteria:
Study Director: | Irina M Kline, MD | Actelion |
Responsible Party: | Actelion ( Sebastien Roux, MD ) |
Study ID Numbers: | AC-052-369, ASSET-2 |
Study First Received: | April 10, 2006 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00313196 |
Health Authority: | United States: Food and Drug Administration |
Pulmonary Hypertension Sickle Cell Disease Sickle cell anemia |
bosentan ASSET ASSET-2 |
Hematologic Diseases Anemia Vascular Diseases Anemia, Hemolytic Bosentan Sickle cell anemia Anemia, Hemolytic, Congenital Genetic Diseases, Inborn |
Respiratory Tract Diseases Hypertension, Pulmonary Hemoglobinopathies Lung Diseases Hemoglobinopathy Anemia, Sickle Cell Hypertension |
Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |