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NCT05649748Recruiting

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
Insmed IncorporatedPhase 2/3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
Treprostinil Palmitil
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Insmed Incorporated
Location
Okayama-Shi,Suita-Shi, Japan
Timeline & enrollment
Phase
Phase 2/3
Start date
Feb 28, 2023
End date
Dec 31, 2026
Enrollment
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 hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationStenosis of pulmonary arteryPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05649748
Type
Non-Device Trial
About this record

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.