Study Phase 3

Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)

Trial Information

Generic NameBosentanProduct NameTRACLEER®Therapeutic AreaCardiovascular SystemProduct ClassAntihypertensivesPharmacological SubgroupOther AntihypertensivesChemical SubgroupAntihypertensives for Pulmonary Arterial HypertensionCondition StudiedIdiopathic Pulmonary Fibrosis
Sponsor Protocol NumberAC-052-322Enrollment128Data PartnerJohnson & Johnson% Female24.2%Mean/Median Age (Years)65.4% WhiteN/A

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

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.