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

Recruiting Phase 3 Interventional Study
Pulmonary Arterial Hypertension (PAH) Comorbidities Cardiovascular Disease (CVD)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
186 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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 …
Trial Locations
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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 s…
Contacts

Laurent SAVALE,, MD, PhD

+33 1 45 21 79 08

laurent.savale@aphp.fr

CONTACT