MedTrace Logo

A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

NCT03714815 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-02-04

Study results available
· View outcomes & findings →

Summary

The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the treatment in the double-blind parent SERENADE study (AC-055G202, NCT03153111). Furthermore, this OL extension study will give eligible subjects of the main study (SERENADE/AC-055G202, NCT03153111) an opportunity to continue or start receiving macitentan.

Conditions

  • Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

Interventions

DRUG

macitentan 10 mg

macitentan 10 mg, film-coated tablet, oral use

Sponsors & Collaborators

  • Almac Clinical Technologies

    collaborator INDUSTRY

  • Frontier Science & Technology Research Foundation, Inc.

    collaborator INDUSTRY

  • Covance

    collaborator INDUSTRY

  • Chiltern International Ltd.

    collaborator INDUSTRY

  • WorldCare Clinical, LLC

    collaborator INDUSTRY

  • AcitGraph

    collaborator OTHER

  • Medidata Solutions

    collaborator INDUSTRY

  • Actelion

    lead INDUSTRY

Principal Investigators

  • William Byra, MD · Actelion

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-07
Primary Completion
2021-10-12
Completion
2021-10-12
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

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 NCT03714815 on ClinicalTrials.gov