Pulmonary Arterial Hypertension study: Tadalafil vs Ambrisentan
Official title COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities
ClinicalTrials.gov ID: NCT07245680
What this study is testing
What is Tadalafil?
Tadalafil is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for pulmonary arterial hypertension (pah).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study wants to find out if starting with two oral medicines is safer and more effective than starting with just one for people with lung artery disease and other heart problems.
- Who it's for
- The study is looking for people who have just been diagnosed with pulmonary arterial hypertension and have at least two other cardiovascular conditions.
- What's involved
- Participants will be randomly assigned to take either two daily pills (tadalafil and ambrisentan) or one daily pill. They will visit the clinic for regular checkups and tests to monitor their health.
- Time commitment
- The study involves regular visits over a period of time to track how well the treatment works and to check for any side effects.
- Phase 3: a large, late-stage study
- Time commitment: about 37 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- mPAP≥25 mmHg and
- PAWP\<15 mmHg and
You likely can't join if
- 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...
See the full eligibility 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
- mPAP≥25 mmHg and
- PAWP\<15 mmHg and
- with PVR≥3 WU
- 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...
- 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
- 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 /...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Le Kremlin-Bicêtre, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 37 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Le Kremlin-Bicêtre, France. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.