A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

Insmed Incorporated

Summary

The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH.

Eligibility

Age range: 18–75 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria * Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in accordance with European Society of Cardiology European Respiratory Society (ESC/ERS) Guidelines: * Idiopathic PAH * Heritable PAH * Drug/toxin-induced PAH * Connective tissue disease (CTD)-associated PAH * PAH associated with congenital heart disease-related to simple systemic-to-pulmonary shunt at least 1 year following repair. * PAH diagnosis for at least 3 months prior to Screening. * New York Heart Association (NYH…

Interventions

Drug
Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
Drug
Placebo
Oral inhalation using a capsule-based dry powder inhaler device.

Summary

Eligibility

Interventions

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