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NCT06317805Recruiting

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

Randomized Trial Comparing Efficacy and Safety of Initial Triple Therapy Including Parenteral Treprostinil to Initial Double Oral Therapy in Pulmonary Arterial Hypertension (PAH) Group I Patients (TripleTRE)
AOP Orphan Pharmaceuticals AGPhase 4ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
Generic treprostinil sodium + Standard of Care (Double Oral)
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AOP Orphan Pharmaceuticals AG
Location
Linz,Vienna,Olomouc,Praha,Paris,Strasbourg,Berlin,Dresden,Greifswald,Budapest,Szeged,Rome,Kraków,Otwock,Lisboa,Bucharest,Târgu-Mureş,Barcelona,Madrid, Austria,Czech,France,Germany,Hungary,Italy,Poland,Portugal,Romania,Spain
Timeline & enrollment
Phase
Phase 4
Start date
Dec 06, 2023
End date
Jun 30, 2027
Enrollment
110 participants
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 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.

ICD-10 classifications
Primary pulmonary hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationStenosis of pulmonary arteryPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06317805
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.