Study comparing tadalafil with ambrisentan versus tadalafil alone in newly diagnosed patients with pulmonary arterial hypertension who have cardiovascular conditions

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What is this study about?

This study focuses on patients with Pulmonary Arterial Hypertension, a condition where blood pressure in the arteries of the lungs is abnormally high. The study aims to compare two different treatment approaches: a combination therapy using two medications versus treatment with a single medication plus placebo. The medications being studied are ambrisentan and tadalafil, which are both taken by mouth in the form of tablets.

The research will examine which treatment strategy is more effective at controlling the disease after 6 months in newly diagnosed patients who also have heart and blood vessel-related health conditions. During the study, participants will be divided into two groups. One group will receive both ambrisentan and tadalafil, while the other group will receive tadalafil and a placebo. The treatment period will last approximately 175 days.

Throughout the study, various aspects of the participants’ health will be monitored, including their ability to exercise, heart function, and overall well-being. The medications being tested are already approved for medical use, but they will be studied in a specific combination to determine if this approach provides better results for patients with additional cardiovascular health conditions.

1 Initial evaluation and medication start

You will start taking either a combination of two medications or one real medication and one placebo:

Ambrisentan 5 mg tablet (or its placebo) taken by mouth once daily

Tadalafil taken by mouth once daily

2 Regular monitoring visits

Your health status will be monitored through several tests:

– Walking test (6-minute walk distance)

– Blood tests including specific markers for heart function

– Heart and lung function tests

– Quality of life questionnaires

– Blood pressure and heart rate measurements

– Weight monitoring

3 6-month evaluation

After 6 months of treatment, your condition will be evaluated to determine:

– Changes in your ability to exercise

– Changes in heart and lung function

– Your overall response to the treatment

– Any side effects you may have experienced

4 Ongoing monitoring

Throughout the study period, you will be monitored for:

– Any changes in your symptoms

– Side effects from the medications

– Need for additional treatments

– Overall health status

5 Study completion

The study is expected to run until October 2028

Your participation will help evaluate the effectiveness of combination therapy versus single medication treatment for pulmonary arterial hypertension

All health changes and medication effects will be documented throughout your participation

Who Can Join the Study?

  • Must be an adult (18 years or older)
  • Must be diagnosed with Pulmonary Arterial Hypertension (PAH) within the last 6 months
  • Must meet specific blood pressure measurements in the lungs:
    • Mean pulmonary artery pressure of 25 mmHg or higher
    • Pulmonary artery wedge pressure of 15 mmHg or less
    • Pulmonary vascular resistance of 3 Wood Units or higher
  • Must have never received treatment for PAH before
  • Must have PAH that is either:
    • Inherited
    • Without known cause
    • Related to drug use
    • Connected to tissue disease
    • Associated with HIV infection
    • Related to corrected heart defect (fixed more than 1 year ago)
  • Must have at least two of these health conditions:
    • High blood pressure
    • Diabetes (any type)
    • Obesity (body mass index of 30 or higher)
    • Heart disease (such as previous heart attack, heart procedures, blocked arteries, or stable chest pain)

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Previous treatment with any medications for pulmonary arterial hypertension (high blood pressure in the lungs)
  • Pregnancy or breastfeeding
  • Severe liver disease
  • Severe kidney disease requiring dialysis
  • History of heart attack or stroke in the past 6 months
  • Uncontrolled high blood pressure
  • Active bleeding disorders
  • Use of nitrate medications for chest pain
  • Known allergic reactions to tadalafil or ambrisentan
  • Participation in other clinical trials within the past 30 days
  • Life-threatening conditions requiring immediate treatment
  • Inability to provide informed consent
  • Substance abuse or addiction that could interfere with study participation
  • Mental health conditions that could affect compliance with study procedures

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
15.09.2025

Trial locations

Investigated drugs:

Tadalafil is a medication that helps relax blood vessels and improves blood flow in the lungs. It belongs to a group of medicines called PDE5 inhibitors and is used to treat pulmonary arterial hypertension (high blood pressure in the lungs). It helps patients breathe more easily and improve their exercise capacity.

Ambrisentan is a medication that works by blocking the action of a natural substance in the body that causes blood vessels to narrow. It helps widen the blood vessels in the lungs, making it easier for the heart to pump blood through them. This medication is used to treat pulmonary arterial hypertension and helps improve the ability to exercise and slow down the worsening of symptoms.

Investigated diseases:

Pulmonary Arterial Hypertension – A rare condition where blood pressure in the arteries of the lungs becomes abnormally high. This happens when the tiny arteries in the lungs become narrow or blocked, making it harder for blood to flow through them. The heart must work harder to pump blood through these narrowed arteries, which causes increased pressure. Over time, the increased workload causes the heart’s right ventricle to become larger and weaker. The condition typically develops gradually, with symptoms including shortness of breath during physical activity, fatigue, dizziness, and chest pain.

Trial ID:
2023-509891-40-00
Protocol code:
APHP230847
Trial Phase:
Therapeutic confirmatory (Phase III)

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