Clinical Trial: BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to

  • Change in 6-minute Walk Distance [ Time Frame: from baseline to week 24 ]
  • Change in Borg Dyspnea Index [ Time Frame: from baseline to week 24 ]
    Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.
  • Number of Participants With a Change in WHO Functional Class [ Time Frame: from baseline to week 24 ]

    Number of participants with a change in WHO functional class from baseline to week 24.

    A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement.



    • Original Primary Outcome:

    • Serious adverse events
    • Adverse events leading to dose reduction, temporary interruption or permanent discontinuation
    • Laboratory tests and oxygen saturation


    Current Secondary Outcome:

    Original Secondary Outcome:

    • Six minute walk test at week 24
    • Borg dyspnea index at week 24


    Information By: Actelion

    Dates:
    Date Received: August 21, 2006
    Date Started: January 2004
    Date Completion:
    Last Updated: August 16, 2016
    Last Verified: July 2016