A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD) (PERFECT)

  • STATUS
    Recruiting
  • participants needed
    314
  • sponsor
    United Therapeutics
Updated on 12 August 2022
diuretics
vasodilator
pulmonary disease
forced expiratory volume
right heart catheterization
treprostinil
left ventricular end-diastolic pressure

Summary

The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in participants with PH-COPD.

Description

This is a multicenter, randomized, double-blind, placebo-controlled, 34-week, cross-over study, with a Treatment Period of approximately 26 weeks under the Original Crossover Design or, if applicable, a 21-week parallel study, with a Treatment Period of approximately 14 weeks under the Contingent Parallel Design.

Details
Condition Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease
Treatment Placebo solution, Inhaled treprostinil solution
Clinical Study IdentifierNCT03496623
SponsorUnited Therapeutics
Last Modified on12 August 2022

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