Trials / Completed
CompletedNCT03153137
Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 142 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Macitentan 10 mg | film-coated tablet; oral use |
| DRUG | Placebo | film-coated tablet; oral use |
Timeline
- Start date
- 2017-08-14
- Primary completion
- 2021-06-30
- Completion
- 2021-07-26
- First posted
- 2017-05-15
- Last updated
- 2025-03-30
- Results posted
- 2022-09-13
Locations
32 sites across 12 countries: United States, Australia, Canada, China, Czechia, Denmark, France, Germany, New Zealand, Poland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03153137. Inclusion in this directory is not an endorsement.