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A Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH) - Trial NCT05649748

Access comprehensive clinical trial information for NCT05649748 through Pure Global AI's free database. This Phase 2/3 trial is sponsored by Insmed Incorporated and is currently Recruiting. The study focuses on Pulmonary Arterial Hypertension. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT05649748
Phase 2/3
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05649748
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A Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)
An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

Study Focus

Treprostinil Palmitil

Interventional

drug

Sponsor & Location

Insmed Incorporated

Okayama-Shi,Suita-Shi, Japan

Timeline & Enrollment

Phase 2/3

Feb 28, 2023

Dec 31, 2026

100 participants

Primary Outcome

Number of Participants Who Experience at Least one Treatment Emergent Adverse Event (TEAE) and TEAEs by Severity

Summary

The primary purpose of the study is to evaluate the safety and tolerability of the long-term
 use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202
 (NCT05147805) and other lead-in studies of TPIP in participants with PAH.

ICD-10 Classifications

Primary pulmonary hypertension
Other secondary pulmonary hypertension
Pulmonary heart disease and diseases of pulmonary circulation
Stenosis of pulmonary artery
Pulmonary heart disease, unspecified

Data Source

ClinicalTrials.gov

NCT05649748

Non-Device Trial