Clinical Trial: Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable
Brief Summary: Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
Detailed Summary:
Sponsor: Actelion
Current Primary Outcome: Pulmonary vascular resistance (PVR) at rest at Week 16 expressed as percent of baseline PVR at rest [ Time Frame: baseline to Week 16 ]
Original Primary Outcome: PVR at rest at Week 16 expressed as percent of baseline PVR at rest [ Time Frame: baseline to Week 16 ]
Current Secondary Outcome:
- Change from baseline to Week 24 in exercise capacity, as measured by the 6-minute walk distance (6MWD). [ Time Frame: baseline to Week 24 ]
- Change from baseline to Week 24 in Borg dyspnea index collected at the end of the 6-minute walk test (6MWT). [ Time Frame: baseline to Week 24 ]
- Proportion of subjects with worsening in WHO functional class from baseline to Week 24 [ Time Frame: baseline to Week 24 ]
Original Secondary Outcome:
- Change from baseline to Week 24 in exercise capacity, as measured by the 6MWD. [ Time Frame: baseline to Week 24 ]
- Change from baseline to Week 24 in Borg dyspnea index collected at the end of the 6MWT. [ Time Frame: baseline to Week 24 ]
- Proportion of subjects with worsening in WHO FC from baseline to Week 24 [ Time Frame: baseline to Week 24 ]
Information By: Actelion
Dates:
Date Received: December 20, 2013
Date Started: August 2014
Date Completion:
Last Updated: October 18, 2016
Last Verified: October 2016
