Phase 3Recruiting
A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH) (PALM-PAH)
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
- Sponsor
- Insmed Incorporated (Industry)
- Enrolment
- 344 planned
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Treprostinil Palmitil Inhalation Powder; Placebo
- Ages
- adults, older adults
- Registry
- NCT07481981, CTIS2026-525265-48-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change in 6-Minute Walk Distance (6MWD) Measured at 1 to 3 Hours Post-Dose From Baseline at Week 24
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered