This is a double-blind, placebo-controlled study to evaluate the effect of inhaled TPIP compared with placebo on exercise capacity in participants with Group 1 pulmonary 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 (PALM-PAH)
Pulmonary hypertension
All genders
18-75
Recruiting now
Overview
Principal Investigator: Harrison Farber, MD
Contact Us
Bipin Malla
Study details
Inclusion Criteria
- Diagnosis of Group 1 Pulmonary Hypertension (PAH) at least 3 months prior
- On PAH specific treatment for at least 90 days with last 30 days on stable dose
- Able towalk at least 150 meters in 6 minutes
Exclusion Criteria
- Clinically significant Left heart disease
- Evidence of obstructive or restrictive lung disease (FEV1/FVC<0.7 or FVC<70% of predicted)
- BMI above 37
Study Requirements
Total duration of study participation is 28 weeks with study visits every 4 weeks (7 to 8 visits total). Each visit will have blood draw, vitals, physical exam and 6 minute walk test (6MWT). Might need to complete a right heart catheterization during at the beginning if it has not been done in past 6 months.