COMMODITIES : Comparison of initial dual oral COMbination therapy to MOnotherapy in pulmonary arterial hypertension with cardiovascular comorbiDITIES

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

28 Apr 2026 → ongoing

Decision date (initial)

2025-08-04

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To analyse the effect of the initial treatment strategy (tadalafil and ambrisentan vs tadalafil and placebo) on disease control assessed at 6-months in treatment-naïve patients with newly diagnosed PAH and cardiovascular comorbidities.

Secondary objectives 3

1. • Document the effect of the initial treatment strategy, at 24 weeks, in treatment-naïve patients with newly diagnosed PAH and cardiovascular comorbidities on mortality, morbidity, quality of life, cardiopulmonary hemodynamic parameters, echocardiographic parameters, exercise capacity, biomarkers
2. • Analyse the effect of the initial treatment strategy on disease control assessed at 12 weeks in treatment-naïve patients with newly diagnosed PAH and cardiovascular comorbidities
3. • To document safety and tolerability of the initial treatment strategy

Conditions and MedDRA coding

Pulmonary arterial hypertension

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. • Male or female
2. • Age ≥ 18 years old
3. • Initial PAH diagnosis < 6 months prior to Day 1
4. • Hemodynamic criteria : mPAP≥25 mmHg and PAWP≤15 mmHg and PVR≥3 WU.
5. • 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
6. • With 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)

Exclusion criteria 4

1. • Pregnancy, breast feeding
2. • Patient under guardianship curatorship, deprived of liberty
3. • Patient under exclusion period in another trial
4. • Patient on AME (state medical aid)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 19

1. • Change in pulmonary vascular resistance
2. • Percent change in BNP or NT-proBNP
3. • Change in 6-minute walk distance
4. • Proportion of participants who improve in WHO/NYHA FC at the end of the DBPC Treatment Period
5. • Change in the TAPSE/systolic pulmonary artery pressure (SPAP) ratio
6. • Rate 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.
7. • Change in the emPHasis10 score
8. • Change in the EuroQoL-5 dimensions scale 5 levels (EQ-5D-5L)
9. • All causes of death
10. • Change in other hemodynamic parameters
11. • Change in other echocardiographic parameters
12. • Change of WHO/NYHA functional class
13. • Rate of death due to PAH
14. • Treatment-emergent adverse events (AEs)
15. • Treatment-emergent serious AEs (SAES)
16. • Treatment-emergent deaths
17. • AEs leading to premature discontinuation of study drug
18. • Change in laboratory variables
19. • Change in weight and vital signs (arterial blood pressure, heart rate).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr. Laurent SAVALE (Coordinating investigator)

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Touria EL AAMRI (project manager)

Locations

1 EU/EEA country · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications