Clinical Trial: Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenge
Brief Summary: Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.
Detailed Summary:
Sponsor: Actelion
Current Primary Outcome: Change from baseline to Week 16 in exercise capacity, as measured by 6MWD [ Time Frame: From baseline to Week 16 ]
Original Primary Outcome: Change from baseline to Week 16 in exercise capacity, as measured by 6MWD [ Time Frame: Baseline to Week 16 ]
Current Secondary Outcome:
- Change from baseline to Week 16 in WHO functional class [ Time Frame: From baseline to Week 16 ]
- Change from baseline to Week 16 in dyspnea (assessed by the Borg dyspnea index) [ Time Frame: From baseline to Week 16 ]
- Change from baseline to Week 16 in quality of life (assessed by the SF-36 questionnaire) [ Time Frame: From baseline to Week 16 ]
Original Secondary Outcome:
- Change from baseline to Week 16 in WHO functional class [ Time Frame: Baseline to Week 16 ]
- Change from baseline to Week 16 in dyspnea (assessed by the Borg dyspnea index) [ Time Frame: Baseline to Week 16 ]
- Change from baseline to Week 16 in quality of life (assessed by the SF-36 questionnaire) [ Time Frame: Baseline to Week 16 ]
Information By: Actelion
Dates:
Date Received: November 29, 2012
Date Started: May 2013
Date Completion:
Last Updated: December 21, 2016
Last Verified: December 2016
