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Study identifier: NCT06317805 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Pulmonary Arterial Hypertension  ·  Sponsor: AOP Orphan Pharmaceuticals AG

PhasePhase 4
Planned participants110
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Project Manager  ·  +43676 3464650  ·  tripletre@aoporphan.com

Always discuss trial participation with your own doctor first.

Locations (19)

Ordensklinikum LinzLinz, AustriaRecruiting
Medical University ViennaVienna, AustriaRecruiting
Fakultní Nemocnice OlomoucOlomouc, CzechiaNot Yet Recruiting
Všeobecná fakultní nemocnice v PrazePrague, CzechiaNot Yet Recruiting
Hôpital Bicêtre-- Assistance Publique Hopitaux de ParisParis, FranceNot Yet Recruiting
Hôpitaux Universitaires de StrasbourgStrasbourg, FranceNot Yet Recruiting
DRK Kliniken Berlin WestendBerlin, GermanyNot Yet Recruiting
University Hospital Carl Gustav Carus of Technical University DresdenDresden, GermanyNot Yet Recruiting
Universitätsmedizin GreifswaldGreifswald, GermanyNot Yet Recruiting
Gottsegen National Cardiovascular lnstituteBudapest, HungaryNot Yet Recruiting
Medical University of SzegedSzeged, HungaryNot Yet Recruiting
Sapienza University of RomeRome, ItalyRecruiting

+ 7 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06317805