Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE

Status: open

18-037 - RIN-PH-201 A Multicenter, Randomized, Double-blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease

Treatment for Pulmonary Arterial Hypertension

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Description

This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 120 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202). IRB Number 18-037

Sponsors

This trial is sponsored by United Therapeutics.

Providers Associated With This Trial

Principle Investigator

  • Karen FaganView Profile
    Karen A. Fagan, M.D.PulmonologistDirector of Division Pulmonary & Critical Care; Director of Pulmonary Hypertension Center; Associate Professor of Internal Medicine
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