Study Phase 3

A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension

  • 1 CSR Summary Not Yet Available
  • 1 NCT01338415
  • 1 Primary Citation Not Available
  • Data Specification Not Available

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment58% Female43.8%% White75%
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-052-374Data PartnerJohnson & JohnsonCondition StudiedHypertension, Pulmonary, ArterialMean/Median Age (Years)4.8

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

Disclaimer

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