Trials / Completed
CompletedNCT05147805
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Insmed Incorporated · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Treprostinil Palmitil | Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler. |
| DRUG | Placebo | Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler. |
Timeline
- Start date
- 2022-08-24
- Primary completion
- 2025-03-27
- Completion
- 2025-03-27
- First posted
- 2021-12-07
- Last updated
- 2026-03-30
Locations
92 sites across 17 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Denmark, Germany, Italy, Japan, Malaysia, Mexico, Philippines, Serbia, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05147805. Inclusion in this directory is not an endorsement.