AMBRISENTAN for Pulmonary arterial hypertension

Inclusion criteria

• {"criterion_text":"- •\tMale or female"}
• {"criterion_text":"- •\tAge ≥ 18 years old"}
• {"criterion_text":"- •\tInitial PAH diagnosis < 6 months prior to Day 1"}
• {"criterion_text":"- •\tHemodynamic criteria : mPAP≥25 mmHg and PAWP≤15 mmHg and PVR≥3 WU."}
• {"criterion_text":"- •\tTreatment naïve PAH (group 1): idiopathic, heritable, associated with drugs and toxin, associated with connective tissue disease, HIV infection or systemic-to-pulmonary congenital shunt corrected for more than one year"}
• {"criterion_text":"- •\tWith at least two of the following criteria as listed in the European pulmonary hypertension guidelines: -\thistory of essential hypertension -\tdiabetes mellitus (any type) -\tobesity (defined by a BMI ≥30 kg/m2) -\tcoronary heart disease (established by any of the following: history of myocardial infarction, history of percutaneous coronary intervention, angiographic evidence of coronary artery disease (>50% stenosis in ≥1 vessel), positive ST, previous coronary artery bypass graft, stable angina)"}

Exclusion criteria

• {"criterion_text":"- •\tPregnancy, breast feeding"}
• {"criterion_text":"- •\tPatient under guardianship curatorship, deprived of liberty"}
• {"criterion_text":"- •\tPatient under exclusion period in another trial"}
• {"criterion_text":"- •\tPatient on AME (state medical aid)"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients with PAH and cardiovascular comorbidities who achieve after 6 months a low- or an intermediate-low risk profile according to the non-invasive 4-risk strata method as proposed by the 2022 European pulmonary hypertension guidelines.","definition_or_measurement_approach":"Assessed after 6 months using the non-invasive 4-risk strata method as proposed by the 2022 European pulmonary hypertension guidelines."}

Secondary endpoints

• {"endpoint_text":"- •\tChange in pulmonary vascular resistance","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tPercent change in BNP or NT-proBNP","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tChange in 6-minute walk distance","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tProportion of participants who improve in WHO/NYHA FC at the end of the DBPC Treatment Period","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tChange in the TAPSE/systolic pulmonary artery pressure (SPAP) ratio","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tRate of Death or Nonfatal Clinical Worsening defined by hospitalisation for PAH worsening or disease progression defined by worsening of functional class and decrease in 6-min walk distance of more than 15% from baseline, or need for additional specific therapy or lung transplantation.","definition_or_measurement_approach":"Defined as hospitalisation for PAH worsening or disease progression defined by worsening of functional class and decrease in 6-min walk distance of more than 15% from baseline, or need for additional specific therapy or lung transplantation."}
• {"endpoint_text":"- •\tChange in the emPHasis10 score","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tChange in the EuroQoL-5 dimensions scale 5 levels (EQ-5D-5L)","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tAll causes of death","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tChange in other hemodynamic parameters","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tChange in other echocardiographic parameters","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tChange of WHO/NYHA functional class","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tRate of death due to PAH","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tTreatment-emergent adverse events (AEs)","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tTreatment-emergent serious AEs (SAES)","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tTreatment-emergent deaths","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tAEs leading to premature discontinuation of study drug","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tChange in laboratory variables","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tChange in weight and vital signs (arterial blood pressure, heart rate).","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

27-06-2025

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

210

Number Of Sites

25

Number Of Participants

186

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France