NCT07245680 COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities
| NCT ID | NCT07245680 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Pulmonary Arterial Hypertension (PAH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2026-04-28 |
| Primary Completion | 2029-02-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 186 participants in total. It began in 2026-04-28 with a primary completion date of 2029-02-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pulmonary arterial hypertension (PAH) is a rare, progressive disease associated with poor prognosis, especially in patients with cardiovascular comorbidities. Current guidelines recommend initial combination therapy, but evidence is lacking for patients with significant comorbidities who are often excluded from clinical trials. The COMMODITIES trial is a multicenter, randomized, controlled study designed to compare the efficacy and safety of initial dual oral combination therapy (tadalafil and ambrisentan) versus oral monotherapy in newly diagnosed PAH patients with at least two cardiovascular comorbidities. The study aims to provide robust evidence to guide treatment strategies in this high-risk population.
Eligibility Criteria
Inclusion Criteria: * Initial PAH diagnosis \< 6 months preceding randomisation * Negative vasoreactivity test * Treatment-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 * Meet all of the following hemodynamic criteria by means of a RHC prior to screening: * mPAP≥25 mmHg and * PAWP\<15 mmHg and * with PVR≥3 WU • Presence of at least two of the following criteria, as listed in the European pulmonary hypertension guidelines: * History of essential hypertension * Diabetes mellitus (any type) * Obesity (defined by a BMI ≥30 kg/m2) * Coronary 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) * Participant able to understand the study procedures * For women of childbearing potential (WOCBP), effective form of contraception\* from screening up to 1 month following discontinuation of the last study treatment * Affiliation to the french social security regime * Signed written informed consent Exclusion Criteria: * Porto-pulmonary hypertension * Uncorrected systemic-to-pulmonary congenital shunt * Evidence of thromboembolic disease assessed by ventilation perfusion (V/Q) lung scan or CT pulmonary angiography * Patients listed for lung or heart-lung transplantation at time of screening * Patients on any PAH-specific drug therapy at any time preceding randomisation * Known moderate-to-severe restrictive lung disease (i.e., total lung capacity \< 60% of predicted value) or obstructive lung disease (i.e., forced expiratory volume in one second \[FEV1\] \< 60% of predicted, with FEV1 / forced vital capacity \< 65%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema). * Known or suspected pulmonary veno-occlusive disease (PVOD) * Severe renal insufficiency (creatinine clearance \< 30 mL/min) * Documented severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin \> 3 x ULN or serum AST and/or ALT \> 3xULN (assessed by local laboratory at screening) and/or Child-Pugh Class C. * Haemoglobin \< 10 g/dL * Patient under guardianship curatorship, deprived of liberty * Pregnant women, or breast-feeding women * Treatment with other PDE-5i for erectile dysfunction * Ongoing or planned treatment with nitrates and/or doxazosin. * Ongoing or planned treatment with riociguat * Treatment with strong inducers of CYP3A4 (e.g., carbamazepine, rifampin, rifampicin, rifabutin, rifapentin, phenobarbital, phenytoin, and St. John's wort) ≤28 days preceding randomisation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07245680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Arterial Hypertension (PAH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07245680 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 186 participants.
Is NCT07245680 currently recruiting?
Yes, NCT07245680 is actively recruiting participants. Contact the research team at laurent.savale@aphp.fr for enrollment information.
Where is the NCT07245680 trial being conducted?
This trial is being conducted at Le Kremlin-Bicêtre, France.
Who is sponsoring the NCT07245680 clinical trial?
NCT07245680 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 186 participants.