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

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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
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Houston, TX
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Boston University School of Medicine A leader in medical education and research, Boston University School...
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Cincinnati, Ohio 45219
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Louisville, Kentucky 40202
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