A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder… (NCT07481981) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)
344 participantsStarted 2026-04-17
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 PAH
* Drug/toxin-induced PAH
* Connective tissue disease (CTD)-associated PAH
* PAH associated with congenital heart disease-related to simple systemic-to-pulmonary shunt at least 1 year following repair.
* PAH diagnosis for at least 3 months prior to Screening.
* New York Heart Association (NYHA) or World Health Organization (WHO) functional class II-IV.
* Participants must be on stable PAH therapy consisting of 1 to 3 medications from the following classes:
* Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan) for at least 90 days prior to Screening with the last 30 days on stable dose.
* Phosphodiesterase type 5 inhibitors (eg, sildenafil, tadalafil) for at least 90 days prior to Screening with the last 30 days on stable dose
* Guanylate cyclase stimulator (eg, riociguat) for at least 90 days prior to Screening with the last 30 days on stable dose
* Activin signaling inhibitor (e.g., sotatercept) for at least 6 months prior to Screening, with the last 3 months on stable dose and meeting all the following conditions:
* no active clinically significant bleeding (eg, epistaxis and gingival bleeding requiring medical interventions) within the pa…
What they're measuring
1
Change in 6-Minute Walk Distance (6MWD) Measured at 1 to 3 Hours Post-Dose From Baseline at Week 24