Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06317805 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: TripleTRE
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT06317805
Lead Sponsor AOP Orphan Pharmaceuticals AG
Collaborators: ANOVA CRO s.r.o., PharmaLex Belgium, Aixial s.r.o., GCP-Service International Ltd. & Co. KG
Conditions
(from sponsor)
Pulmonary Arterial Hypertension
Related terms Pulmonary Arterial Hypertension
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov