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

NCT02070991 | Completed Phase 2 Results

• 1 other identifier: AC-055G201
• Study Type: interventional
• Target: 63
• Locations: 11 countries
• Sites: 32

Brief 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.

Conditions

Pulmonary Hypertension

Keywords

pre- and post-capillary pulmonary hypertension; CpcPH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest

  From randomization up to end of treatment period (Week 12)

• PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest

  From randomization up to end of treatment period (Week 12)

• Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)

  From randomization up to end of treatment period (Week 12)

• Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)

  From randomization up to end of treatment period (Week 12)

• Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)

  From randomization up to end of treatment period (Week 12)

Study Arms (2)

Macitentan

EXPERIMENTAL

oral tablet, 10 mg once daily.

Drug: Macitentan

Placebo

PLACEBO COMPARATOR

Matching placebo, once daily.

Drug: Placebo

Interventions

Macitentan DRUG

oral tablet, 10 mg once daily

Also known as: ACT-064992

Macitentan

Placebo DRUG

matching placebo

Also known as: matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females \>=18 years of age
• Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)
• Optimized diuretic therapy

You may not qualify if:

• Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
• Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)

Sponsors & Collaborators

• Actelion: lead

Study Sites (32)

Kentuckiana Pulmonary Associates

Louisville, Kentucky, 40202, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

University of Michigan Internal Medicine Cardiology, Pulmonary Hypertension Program

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine - Center for Advanced Med

St Louis, Missouri, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, United States

Location

Houston Methodist Hospital - Heart Failure/Pulm Hypertension

Houston, Texas, United States

Location

Krankenhaus der Elisabethinen Linz, 2. Interne Abteilung

Linz, Austria

Location

Medical University of Vienna and AKH Cardiology

Vienna, A-1090, Austria

Location

Hôpital Erasme, Cliniques Universitaires de Bruxelles, Cardiologie

Brussels, 1070, Belgium

Location

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

Leuven, 3000, Belgium

Location

Vancouver General Hospital - The Lung

Vancouver, Canada

Location

FN Brno-Bohunice, I. interní kardiologická klinika

Brno, Czechia

Location

FN Olomouc, 1. Interní klinika - kardiologická

Olomouc, Czechia

Location

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

Prague, Czechia

Location

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

Prague, Czechia

Location

Hôpital Charles Nicolle Service de Cardiologie

Rouen, France

Location

DRK Klinken Berlin Kopenick Klinik für Innere Medizin Kardiologie

Berlin, Germany

Location

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

Cologne, Germany

Location

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

Kiel, Germany

Location

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

Munich, Germany

Location

Carmel Medical Center, Pulmonary Unit

Haifa, 34362, Israel

Location

Institute of Pulmonology Hadassah Medical Centre : Ein Karem

Jerusalem, 91120, Israel

Location

Kaplan Medical Centre / Pulmonary Institute and Department of Medicine

Rehovot, 76100, Israel

Location

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

Tel Litwinsky, 52621, Israel

Location

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

Bologna, 40138, Italy

Location

Ospedali Riuniti Di Trieste

Trieste, 34149, Italy

Location

Hospital Vall d´Hebron Servicio de Cardiologia

Barcelona, 08035, Spain

Location

Hospital Clinic Servicio de Cardiologia

Barcelona, 08036, Spain

Location

Hospital Reina Sofia Servicio de Cardiologia

Córdoba, 14004, Spain

Location

Hospital Universitario 12 Octubre Servicio de Cardiología

Madrid, 28041, Spain

Location

Universitätsklinik für Kardiologie Schweizer Herz- und Gefässzentrum Bern

Bern, Switzerland

Location

Centre Hospitalier Universitaire Vaudois Service de Cardiologie

Lausanne, Switzerland

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

macitentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clinical Trial Disclosure Desk
• Organization: Actelion Pharmaceuticals Ltd

clinical-trials-disclosure@its.jnj.com

+41 61 565 6565

Study Officials

• Sébastien Roux, PhD

  Actelion

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 15, 2019
• Results First Posted: May 15, 2019

Record last verified: 2019-04

Locations

BE (2); CH (2); CZ (4); AU (2); IT (2); FR (1); US (6); CA (1); DE (4); IL (4); ES (4)