Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction

Pulmonary Hypertension Clinical Trial

— MELODY-1  

Official title:

A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, 12-week Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070991
• Other study ID #: AC-055G201
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2014
• Est. completion date: November 1, 2015

Study information

• Verified date: April 2019
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 1, 2015
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and Females >=18 years of age

2. Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)

3. Optimized diuretic therapy

Exclusion Criteria:

1. Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)

2. Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Drug:
• Macitentan
oral tablet, 10 mg once daily
• Placebo
matching placebo

Locations

Country	Name	City	State
Austria	Krankenhaus der Elisabethinen Linz, 2. Interne Abteilung	Linz
Austria	Medical University of Vienna and AKH Cardiology	Vienna
Belgium	Hôpital Erasme, Cliniques Universitaires de Bruxelles, Cardiologie	Brussels
Belgium	University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie	Leuven
Canada	Vancouver General Hospital - The Lung	Vancouver
Czechia	FN Brno-Bohunice, I. interní kardiologická klinika	Brno
Czechia	FN Olomouc, 1. Interní klinika - kardiologická	Olomouc
Czechia	IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)	Praha
Czechia	Lékarská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie	Praha
France	Hôpital Charles Nicolle Service de Cardiologie	Rouen cedex
Germany	DRK Klinken Berlin Kopenick Klinik für Innere Medizin Kardiologie	Berlin
Germany	Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Innere Medizin III Kardiologie und Angiologie	Kiel
Germany	Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)	Köln
Germany	Klinikum der Universität München Medizinische Klinik und Poliklinik 1 - Großhadern Schwerpunkt Pneumologie	Munich
Israel	Carmel Medical Center, Pulmonary Unit	Haifa
Israel	Institute of Pulmonology Hadassah Medical Centre : Ein Karem	Jerusalem
Israel	Kaplan Medical Centre / Pulmonary Institute and Department of Medicine	Rehovot
Israel	The Chaim Sheba Medical Center / The Institute of Pulmonology, Physiology and Exercise	Tel-Hashomer
Italy	A.O. Universitaria Policlinico S. Orsola-Malpighi - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale - Unità Operativa di Cardiologia	Bologna
Italy	Ospedali Riuniti Di Trieste	Trieste
Spain	Hospital Clinic Servicio de Cardiologia	Barcelona
Spain	Hospital Vall d´Hebron Servicio de Cardiologia	Barcelona
Spain	Hospital Reina Sofia Servicio de Cardiologia	Cordoba
Spain	Hospital Universitario 12 Octubre Servicio de Cardiología	Madrid
Switzerland	Universitätsklinik für Kardiologie Schweizer Herz- und Gefässzentrum Bern	Bern
Switzerland	Centre Hospitalier Universitaire Vaudois Service de Cardiologie	Lausanne
United States	University of Michigan Internal Medicine Cardiology, Pulmonary Hypertension Program	Ann Arbor	Michigan
United States	Boston University School of Medicine	Boston	Massachusetts
United States	The Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Houston Methodist Hospital - Heart Failure/Pulm Hypertension	Houston	Texas
United States	Kentuckiana Pulmonary Associates	Louisville	Kentucky
United States	Washington University School of Medicine - Center for Advanced Med	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  Israel,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment	The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by = 5% or = 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.	From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day
Secondary	NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest		From randomization up to end of treatment period (Week 12)
Secondary	PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest	Pulmonary vascular resistance (PVR) was assessed at rest by right heart catheterization (RHC).	From randomization up to end of treatment period (Week 12)
Secondary	Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)		From randomization up to end of treatment period (Week 12)
Secondary	Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)		From randomization up to end of treatment period (Week 12)
Secondary	Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)		From randomization up to end of treatment period (Week 12)
Secondary	Change From Baseline to Week 12 in Cardiac Index (CI)		From randomization up to end of treatment period (Week 12)
Secondary	Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG)		From randomization up to end of treatment period (Week 12)