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Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome

NCT01743001 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2018-02-23

Study results available
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Summary

Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.

Conditions

Interventions

DRUG

Macitentan 10 mg

Macitentan 10 mg oral tablet once daily

DRUG

Placebo

Macitentan-matching placebo oral tablet once daily

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
2013-05-21
Primary Completion
2016-12-01
Completion
2016-12-01

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01743001 on ClinicalTrials.gov