At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Inhaled Treprostinil and Placebo for Pulmonary Hypertension and 2 related conditions. Completed, enrolled 326 participants across 97 sites in 2 countries.
Detailed Summary
This was 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 included 326 patients at approximately 120 clinical trial centers. The treatment phase of the study lasted approximately 16 weeks. Patients who completed all required assessments were eligible to enter an open-label, extension study (RIN-PH-202).
Study Details
Timeline
Interventions
Inhaled treprostinil (6 mcg/breath) administered four times daily
Placebo administered four times daily