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

Status:	Completed
Conditions:	High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Cardiology, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	2/18/2017
Start Date:	July 2014
End Date:	November 2015

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

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.

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)

We found this trial at

sites

University of Michigan Internal Medicine Cardiology, Pulmonary Hypertension Program

Ann Arbor, Michigan 48109

from

Ann Arbor, MI