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A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
344
Start Date
2026-07-21
Completion Date
2029-01-28
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
Placebo
Oral inhalation using a capsule-based dry powder inhaler device.
Locations (26)
USA012
Los Angeles, California, United States
USA008
Santa Barbara, California, United States
USA005
Torrance, California, United States
USA010
Kansas City, Kansas, United States
USA028
Omaha, Nebraska, United States
USA013
Rochester, New York, United States
USA006
Philadelphia, Pennsylvania, United States
USA007
Anderson, South Carolina, United States
ARG001
Buenos Aires, Buenos Aires F.D., Argentina
ARG004
Río Cuarto, Córdoba Province, Argentina
AUS002
Camperdown, New South Wales, Australia
AUS003
Westmead, New South Wales, Australia
ISR001
Jerusalem, Israel
ISR004
Petah Tikva, Israel
ISR005
Ramat Gan, Israel
ISR003
Tel Aviv, Israel
JPN011
Narashino, Chiba, Japan
JPN015
Yahatanishi-ku, Kita Kyushu-shi, Fukuoka, Japan
JPN007
Sapporo, Hokkaido, Japan
JPN002
Sapporo, Hokkaido, Japan
JPN014
Kobe, Hyōgo, Japan
JPN003
Okayama, Okayama-ken, Japan
JPN017
Minato-ku, Tokyo, Japan
NZL001
Auckland, New Zealand
NZL003
Dunedin, New Zealand
NZL002
Hamilton, New Zealand