Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients - Trial NCT06317805
Access comprehensive clinical trial information for NCT06317805 through Pure Global AI's free database. This Phase 4 trial is sponsored by AOP Orphan Pharmaceuticals AG and is currently Recruiting. The study focuses on Pulmonary Arterial Hypertension. Target enrollment is 110 participants.
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Study Focus
Generic treprostinil sodium + Standard of Care (Double Oral)
Interventional
drug
Sponsor & Location
AOP Orphan Pharmaceuticals AG
Timeline & Enrollment
Phase 4
Dec 06, 2023
Jun 30, 2027
Primary Outcome
Patients achieving (non-)response status to the assigned treatment in terms of achievement of low-risk status
Summary
TripleTRE investigates the effect of initial triple combination therapy (oral endothelin
 receptor antagonist (ERA) + oral phosphodiesterase tyรผe-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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06317805
Non-Device Trial