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A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

NCT03153111 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2025-03-30

Study results available
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Summary

This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease.

The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.

Conditions

Interventions

DRUG

Macitentan

macitentan 10 mg; film-coated tablet; oral use

DRUG

Placebo

film-coated tablet (identical to the macitentan tablet); oral use

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2021-03-12
Completion
2021-03-12
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Bulgaria
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Poland
  • Romania
  • Russia
  • Spain
  • Sweden
  • United Kingdom

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 NCT03153111 on ClinicalTrials.gov