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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

NCT ID: NCT02070991

Last Updated: 2019-05-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-01

Study Completion Date

2015-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Macitentan

oral tablet, 10 mg once daily.

Group Type EXPERIMENTAL

Macitentan

Intervention Type DRUG

oral tablet, 10 mg once daily

Placebo

Matching placebo, once daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo

Interventions

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Macitentan

oral tablet, 10 mg once daily

Intervention Type DRUG

Placebo

matching placebo

Intervention Type DRUG

Other Intervention Names

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ACT-064992 matching placebo

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien Roux, PhD

Role: STUDY_CHAIR

Actelion

Locations

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Kentuckiana Pulmonary Associates

Louisville, Kentucky, United States

Site Status

Boston University School of Medicine

Boston, Massachusetts, United States

Site Status

University of Michigan Internal Medicine Cardiology, Pulmonary Hypertension Program

Ann Arbor, Michigan, United States

Site Status

Washington University School of Medicine - Center for Advanced Med

St Louis, Missouri, United States

Site Status

The Lindner Clinical Trial Center

Cincinnati, Ohio, United States

Site Status

Houston Methodist Hospital - Heart Failure/Pulm Hypertension

Houston, Texas, United States

Site Status

Krankenhaus der Elisabethinen Linz, 2. Interne Abteilung

Linz, , Austria

Site Status

Medical University of Vienna and AKH Cardiology

Vienna, , Austria

Site Status

Hôpital Erasme, Cliniques Universitaires de Bruxelles, Cardiologie

Brussels, , Belgium

Site Status

University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie

Leuven, , Belgium

Site Status

Vancouver General Hospital - The Lung

Vancouver, , Canada

Site Status

FN Brno-Bohunice, I. interní kardiologická klinika

Brno, , Czechia

Site Status

FN Olomouc, 1. Interní klinika - kardiologická

Olomouc, , Czechia

Site Status

IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)

Prague, , Czechia

Site Status

Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie

Prague, , Czechia

Site Status

Hôpital Charles Nicolle Service de Cardiologie

Rouen, , France

Site Status

DRK Klinken Berlin Kopenick Klinik für Innere Medizin Kardiologie

Berlin, , Germany

Site Status

Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)

Cologne, , Germany

Site Status

Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Innere Medizin III Kardiologie und Angiologie

Kiel, , Germany

Site Status

Klinikum der Universität München Medizinische Klinik und Poliklinik 1 - Großhadern Schwerpunkt Pneumologie

Munich, , Germany

Site Status

Carmel Medical Center, Pulmonary Unit

Haifa, , Israel

Site Status

Institute of Pulmonology Hadassah Medical Centre : Ein Karem

Jerusalem, , Israel

Site Status

Kaplan Medical Centre / Pulmonary Institute and Department of Medicine

Rehovot, , Israel

Site Status

The Chaim Sheba Medical Center / The Institute of Pulmonology, Physiology and Exercise

Tel Litwinsky, , Israel

Site Status

A.O. Universitaria Policlinico S. Orsola-Malpighi - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale - Unità Operativa di Cardiologia

Bologna, , Italy

Site Status

Ospedali Riuniti Di Trieste

Trieste, , Italy

Site Status

Hospital Vall d´Hebron Servicio de Cardiologia

Barcelona, , Spain

Site Status

Hospital Clinic Servicio de Cardiologia

Barcelona, , Spain

Site Status

Hospital Reina Sofia Servicio de Cardiologia

Córdoba, , Spain

Site Status

Hospital Universitario 12 Octubre Servicio de Cardiología

Madrid, , Spain

Site Status

Universitätsklinik für Kardiologie Schweizer Herz- und Gefässzentrum Bern

Bern, , Switzerland

Site Status

Centre Hospitalier Universitaire Vaudois Service de Cardiologie

Lausanne, , Switzerland

Site Status

Countries

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

Other Identifiers

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AC-055G201

Identifier Type: -

Identifier Source: org_study_id

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