Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
Public ClinicalTrials.gov record NCT03153137. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT03153137
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Actelion
- Industry
- Enrollment
- 142 participants
Conditions and interventions
Conditions
Interventions
- Macitentan 10 mg Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 13, 2017
- Primary completion
- Jun 29, 2021
- Completion
- Jul 25, 2021
- Last update posted
- Mar 29, 2025
2017 – 2021
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233-1935 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Massachusetts General Hospital Heart Center | Boston | Massachusetts | 02114 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Texas Children's Hospital | Houston | Texas | 77030-2303 | — |
| Providence Medical Research Providence Health Care | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03153137, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 29, 2025 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03153137 live on ClinicalTrials.gov.