Study Phase 3

An Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed FUTURE 1

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaCardiovascular SystemEnrollment36% Female58.3%% WhiteN/A
Product ClassAntihypertensivesSponsor Protocol NumberAC-052-367Data PartnerJohnson & JohnsonCondition StudiedPulmonary Arterial HypertensionMean/Median Age (Years)6.8

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

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