MedTrace Logo

Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects

NCT03153137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-03-30

Study results available
· View outcomes & findings →

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

  • Congenital Heart Disease

Interventions

DRUG

Macitentan 10 mg

film-coated tablet; oral use

DRUG

Placebo

film-coated tablet; oral use

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-14
Primary Completion
2021-06-30
Completion
2021-07-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • New Zealand
  • Poland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03153137 on ClinicalTrials.gov