C5001004 - A Phase 2, Open-Label Extension Study to Investigate the Safety and Efficacy of PF-07868489 Administered to Adult Participants With Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a serious condition where high blood pressure develops in the blood vessels connecting the heart and lungs. This can cause shortness of breath, extreme tiredness, and extra strain on the heart. This Phase 2 clinical trial is testing an investigational drug called PF-07868489. Because this is an 'open-label extension' study, everyone who takes part will receive the active study medicine; no one will receive a dummy treatment (placebo). The main goal is to find out if the medicine is safe to take over a longer period. Doctors will monitor participants closely for any side effects and measure how the drug affects the body. They will track changes in blood pressure, heart rhythm, and blood tests that show heart health. The study is open to adults aged 18 and over with PAH.
At a glance
What is this study about?
Pulmonary arterial hypertension, often shortened to PAH, is a condition where the blood vessels in the lungs become narrowed, stiff, or blocked. This makes it difficult for blood to flow through the lungs, forcing the right side of the heart to work much harder to pump blood. Over time, this extra workload can weaken the heart muscle, leading to symptoms like breathlessness during everyday tasks, dizziness, and swelling in the legs.
This study focuses on a new investigational medicine named PF-07868489. It is designed to see if this treatment can safely help people manage their PAH. Because this is an 'extension study', it allows researchers to see what happens when patients take the medicine over a longer period. It is also 'open-label', meaning that both you and the research doctors will know you are taking the study drug.
The main purpose of this research is to check the medicine's safety and see how well it is tolerated. Doctors will look carefully for any side effects and track how the body processes the drug. They will also look at markers of heart stress in the blood to learn if the medicine helps the heart pump more easily.
Key takeaways
- Tests an experimental drug called PF-07868489 for pulmonary arterial hypertension.
- This is an open-label study, so all participants receive the active medicine.
- The main focus is finding out if the treatment is safe over a longer period.
- Involves regular clinic visits for heart tests, blood checks, and health monitoring.
- Taking part is completely voluntary, and you can stop at any time.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with pulmonary arterial hypertension. Men and women can both take part.
Because this is an extension trial, participants usually need to have already completed an earlier study testing the same medicine. You must also be able to visit the study clinic regularly so the medical team can check on your health.
People with certain other severe medical conditions or unstable health problems may not be able to join. The trial team will review your complete medical history and current medicines to make sure it is safe for you to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with pulmonary arterial hypertension (PAH).
- I have previously taken part in an earlier study with this medicine (if required by the clinic).
- I am able and willing to attend scheduled hospital appointments and have routine health checks.
What does participation involve?
If you take part, you will be given the study medicine, PF-07868489, to take as directed by the clinic team. You will need to attend regular clinic appointments so the doctors can check on your progress. During these visits, the team will check your vital signs (such as blood pressure and heart rate), carry out electrocardiograms (ECGs) to monitor your heart rhythm, and take blood and urine samples. They will also run blood tests to measure heart stress and check how much medicine is in your system. The trial team will explain how long you will take the medicine and how often visits will happen. You will be asked to report any new symptoms or side effects throughout your time in the study.
Potential risks and benefits
Locations (7)
- —UnverifiedItaly
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedGreece
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedFrance
Common questions
What does an 'open-label' study mean?
It means that both you and the doctors know you are receiving the real study drug. There is no dummy medicine (placebo) used in this trial.
Why is this called an 'extension' study?
An extension study usually continues to follow people who finished a previous trial. It allows researchers to see how safe and effective the medicine is when taken over a longer period.
What is pulmonary arterial hypertension?
It is a type of high blood pressure that specifically affects the arteries in your lungs and the right side of your heart, making it harder to breathe and pump blood.
Will taking part cost me anything?
No, the study drug and all trial-related tests are provided free of charge. Many trials also help cover reasonable travel expenses to and from the hospital.
Can I stop taking the medicine if I want to?
Yes. You have the right to withdraw from the study at any time. Your usual medical care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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