Clinical Trial: Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension

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

Official Title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable

  • Change from Baseline to Week 16 in 6-Minute Walk Test distance [ Time Frame: Week 16 ]
  • Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest [ Time Frame: Week 16 ]


    • Original Primary Outcome:

    • Change from Baseline to Week 16 in 6-Minute Walk Test distance
    • Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest


    Current Secondary Outcome:

    • Change from Baseline to Week 16 in modified NYHA functional class [ Time Frame: Week 16 ]
    • Time to clinical worsening [ Time Frame: Time to clinical worsening ]


    Original Secondary Outcome:

    • Change from Baseline to Week 16 in modified NYHA functional class
    • Time to clinical worsening


    Information By: Actelion

    Dates:
    Date Received: April 10, 2006
    Date Started: October 2005
    Date Completion:
    Last Updated: February 11, 2010
    Last Verified: February 2010