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Sponsored by: |
Encysive Pharmaceuticals |
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Information provided by: | Encysive Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00080457 |
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).
Condition | Intervention | Phase |
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Pulmonary Hypertension |
Drug: sitaxsentan sodium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension (PAH) |
Estimated Enrollment: | 240 |
Study Start Date: | May 2003 |
Study Completion Date: | January 2005 |
The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) as compared to placebo in the treatment of patients with PAH. A cohort of patients will be randomized to usual treatment with Tracleer® (bosentan) for observational comparisons of safety and efficacy.
Ages Eligible for Study: | 12 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have a current diagnosis of symptomatic PAH classified by one of the following:
PAH associated with one of the following congenital heart defects:
Have a cardiac catheterization within 6 months before study entry that shows the following values:
Exclusion Criteria:
Study ID Numbers: | STRIDE 2 |
Study First Received: | April 1, 2004 |
Last Updated: | November 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00080457 |
Health Authority: | United States: Food and Drug Administration |
Primary or secondary pulmonary arterial hypertension Scleroderma Connective tissue disease |
Congenital heart defects Lupus Pulmonary Arterial Hypertension |
Idiopathic pulmonary hypertension Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Vascular Diseases |
Connective Tissue Diseases Neoplasm Metastasis Heart Defects, Congenital Bosentan Hypertension |
Cardiovascular Diseases |