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Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

NCT02021292 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-03-30

Study results available
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Summary

Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).

Conditions

  • Chronic Thromboembolic Pulmonary Hypertension

Interventions

DRUG

Macitentan

Macitentan 10 mg, oral tablet, to be taken once daily.

DRUG

Placebo

Matching placebo oral tablet, to be taken once daily.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Kelly Papadakis, MD · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-08-20
Primary Completion
2016-09-28
Completion
2016-09-28

Countries

  • Belgium
  • China
  • Czechia
  • France
  • Germany
  • Hungary
  • Lithuania
  • Mexico
  • Poland
  • Russia
  • South Korea
  • Switzerland
  • 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 NCT02021292 on ClinicalTrials.gov