Study Phase 3

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)

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment157% Female64.9%% WhiteN/A
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-052-366Data PartnerJohnson & JohnsonCondition StudiedPulmonary Arterial HypertensionMean/Median Age (Years)63.1

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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