Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07245680

COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-05-13

186

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Bicêtre -Service de pneumologie et soins intensifs respiratoires

Le Kremlin-Bicêtre, France, 94270

Actively Recruiting

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Research Team

L

Laurent SAVALE,, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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