NCT03714815

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

A Long-term, Multicenter, Single-arm, Open-label Extension of the SERENADE Study, to Assess the Safety and Efficacy of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	macitentan 10 mg	macitentan 10 mg, film-coated tablet, oral use

Timeline

• Start date: 2018-12-07
• Primary completion: 2021-10-12
• Completion: 2021-10-12
• First posted: 2018-10-22
• Last updated: 2025-02-04
• Results posted: 2022-11-04

Locations

44 sites across 15 countries: United States, Argentina, Austria, Brazil, Bulgaria, Denmark, France, Germany, Hungary, Israel, Poland, Romania, Russia, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study