Pulmonary hypertension is a chronic life-threatening disease that cripples the lungs and heart.
The only currently approved therapy for PHT is intravenous, complicated by administration difficulties and side effects. This double blind, placebo-controlled trial involved 32 patients. Though limited in patient number, the findings are important and relevant considering the magnitude of the clinical and hemodynamic responses which achieved statistical significance. The trial was sponsored by Actelion Pharmaceuticals Ltd, developers of Tracleer. The company has filed initial data with the U.S. Food and Drug Administration and expects to complete the NDA filing for Tracleer for use in patients with pulmonary hypertension by the end of November 2000.