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A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

NCT04271475 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2025-06-27

Study results available
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Summary

The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

Conditions

  • Chronic Thromboembolic Pulmonary Hypertension

Interventions

DRUG

Macitentan

Participants will receive Macitentan film-coated tablets orally od.

DRUG

Placebo

Participant will receive matching placebo tablets orally od.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Actelion Clinical Trial · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2023-12-21
Completion
2023-12-21
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • China
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Lithuania
  • Mexico
  • Poland
  • Portugal
  • Romania
  • Russia
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • 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 NCT04271475 on ClinicalTrials.gov