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
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
- DrugTreprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
- DrugPlacebo
Oral inhalation using a capsule-based dry powder inhaler device.
Locations (2)
- USA008Santa Barbara, California
- USA007Anderson, South Carolina