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PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial

NCT02382016 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-03-30

Study results available
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Summary

24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.

Conditions

  • Portopulmonary Hypertension

Interventions

DRUG

Macitentan

Macitentan film-coated tablet 10 mg once daily.

OTHER

Placebo

Matching placebo tablet once daily.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Loïc Perchenet, PhD · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-23
Primary Completion
2017-10-25
Completion
2018-10-31

Countries

  • United States
  • Brazil
  • Czechia
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

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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 NCT02382016 on ClinicalTrials.gov