Treprostinil Inhalation Powder for Pulmonary Arterial Hypertension

A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)

Recruiting Phase 3 Interventional Study
Pulmonary Arterial Hypertension
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
344 (estimated)
Sponsor
Insmed Incorporated · Industry
Who this trial is looking for

This trial is looking for adults with pulmonary arterial hypertension (PAH) who want to try a new inhalation treatment. Participants will take the treatment once a day for 24 weeks and will be monitored for changes in their exercise ability.

Are You a Good Fit for This Trial?
Must be taking Endothelin receptor antagonistsPhosphodiesterase type 5 inhibitorsGuanylate cyclase stimulatorActivin signaling inhibitor

You may be able to join if

  • I have PAH for at least 3 months.
  • I am aged 18 or older.
  • I can perform a 6-minute walk test with a distance between 150 and 450 meters.
  • I am in functional class II-IV according to NYHA or WHO standards.
  • I am currently taking 1 to 3 stable medications for PAH.
  • I have had a right heart catheterization that meets specific pressure requirements.

You may not be able to join if

  • I have a different type of pulmonary hypertension.
  • I have significant heart disease.
  • I have severe lung problems or restrictive lung disease.
  • I’ve had a recent blood clot in my lungs.
  • I am allergic to treprostinil or its ingredients.
  • I have had major bleeding recently or are at risk.
  • I have other serious medical conditions that could affect my safety.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria * Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in accordance with European Society of Cardiology European Respiratory Society (ESC/ERS) Guidelines: * Idiopathic PAH * Heritable PA…
Contacts

Insmed Medical Information

18444467633

medicalinformation@insmed.com

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