Overview

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

Status:
Completed

Trial end date:
2021-10-12

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Actelion

Collaborators:

AcitGraph
AcitGraph Corp.
Almac Clinical Technologies, LLC
Chiltern International Ltd.
Covance Central Laboratory Services, LP
Frontier Science & Technology Research Foundation, Inc.
Medidata Solutions
WorldCare Clinical, LLC

Treatments:

Macitentan