Trials / Completed
CompletedNCT01743001
Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome
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 Eisenmenger Syndrome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 226 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Macitentan 10 mg | Macitentan 10 mg oral tablet once daily |
| DRUG | Placebo | Macitentan-matching placebo oral tablet once daily |
Timeline
- Start date
- 2013-05-21
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2012-12-06
- Last updated
- 2018-02-23
- Results posted
- 2018-01-30
Locations
55 sites across 21 countries: United States, Austria, Bulgaria, Chile, China, France, Germany, Greece, Israel, Malaysia, Mexico, Philippines, Poland, Portugal, Romania, Russia, Serbia, Spain, Turkey (Türkiye), United Kingdom, Vietnam
Source: ClinicalTrials.gov record NCT01743001. Inclusion in this directory is not an endorsement.