Trials / Terminated
TerminatedNCT01739400
Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
Long Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 217 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Macitentan 10 mg tablet, once daily. | Macitentan 10 mg tablet, once daily. |
Timeline
- Start date
- 2013-09-10
- Primary completion
- 2018-01-12
- Completion
- 2018-01-12
- First posted
- 2012-12-03
- Last updated
- 2019-04-16
- Results posted
- 2019-04-16
Locations
51 sites across 19 countries: United States, Austria, Bulgaria, Chile, China, France, Germany, Greece, Malaysia, Mexico, Philippines, Poland, Portugal, Romania, Russia, Serbia, Spain, United Kingdom, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01739400. Inclusion in this directory is not an endorsement.