PAH Study – Healthy Solutions
35994 05/21/2019 General Health 131 /A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HFpEF)
Brief description of study
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HFpEF)
Detailed Study Description
The primary objective of this study is to assess the effect of oral treprostinil compared with placebo on change in exercise capacity as measured by change in 6MWD from Baseline to Week 24 in subjects with PH associated with HFpEF. There are no approved treatments for PH in subjects with left heart disease; however, the efficacy of therapies in WHO Group 1 PAH, along with lack of evidence-based therapies available for the treatment of HFpEF, have stimulated further investigation in this indication.
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