Overview

Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients

Status:
RECRUITING

Trial end date:
2027-06-30

Target enrollment:

Participant gender:

Summary

TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy (oral ERA + oral PDE-5i) in pulmonary arterial hypertension (PAH) patients (group I) with intermediate-high risk or patients with intermediate-low risk with severe hemodynamic impairment at baseline in a prospective, randomized, unblinded setting with scope of increasing evidence for optimization of therapy concepts in PAH. The effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment.

Phase:

PHASE4

Details

Lead Sponsor:

AOP Orphan Pharmaceuticals AG

Collaborators:

Aixial s.r.o.
ANOVA CRO s.r.o.
GCP-Service International Ltd. & Co. KG
PharmaLex Belgium

Treatments:

Standard of Care