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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT02070991

Run by

Actelion

People needed

63

Starts

2014-07-01

Expected to finish

2015-11-01

Last updated by the study team

2019-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• University of Michigan Internal Medicine Cardiology, Pulmonary Hypertension Program — Ann Arbor, Michigan, United States
• Washington University School of Medicine - Center for Advanced Med — St Louis, Missouri, United States
• The Lindner Clinical Trial Center — Cincinnati, Ohio, United States
• Houston Methodist Hospital - Heart Failure/Pulm Hypertension — Houston, Texas, United States
• Krankenhaus der Elisabethinen Linz, 2. Interne Abteilung — Linz, Austria
• Medical University of Vienna and AKH Cardiology — Vienna, Austria
• Hôpital Erasme, Cliniques Universitaires de Bruxelles, Cardiologie — Brussels, Belgium
• University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie — Leuven, Belgium
• Vancouver General Hospital - The Lung — Vancouver, Canada
• 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) — Prague, Czechia
• Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie — Prague, Czechia
• Hôpital Charles Nicolle Service de Cardiologie — Rouen, France
• DRK Klinken Berlin Kopenick Klinik für Innere Medizin Kardiologie — Berlin, Germany
• Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin) — Cologne, Germany
• Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Innere Medizin III Kardiologie und Angiologie — Kiel, Germany
• Klinikum der Universität München Medizinische Klinik und Poliklinik 1 - Großhadern Schwerpunkt Pneumologie — Munich, Germany
• 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 Litwinsky, Israel
• A.O. Universitaria Policlinico S. Orsola-Malpighi - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale - Unità Operativa di Cardiologia — Bologna, Italy

Full record on ClinicalTrials.gov

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