A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489
This study is about a medicine called PF-07868489 for a condition called Pulmonary Arterial Hypertension (PAH). PAH means you have high blood pressure in the arteries that carry blood from your heart to your lungs. This makes your heart work harder. This particular study is for people who have already taken part in a previous study with PF-07868489. We want to see how safe the medicine is and if it helps over a longer period. Both you and your doctor will know you are receiving the study medicine. This is an 'extension study', meaning it allows people from a previous study to keep taking the medicine to check its long-term effects and safety.
At a glance
What is this study about?
This research study is looking at a medicine called PF-07868489. It's being investigated as a possible treatment for a serious condition known as Pulmonary Arterial Hypertension (PAH). With PAH, the blood vessels in your lungs have high blood pressure. This makes your heart, especially the right side, work much harder to pump blood through your lungs, and over time, this can cause damage.
The main goal of this particular study is to understand more about the long-term safety, how well people tolerate the medicine (meaning, do they experience side effects), and if it helps with their PAH over a longer period. This study is specially designed for people who have already taken part in a previous study where they received PF-07868489. Essentially, it allows those individuals to continue receiving the medicine and for researchers to gather more information.
This kind of study is called an 'open-label' study. This means that both you, as a participant, and your healthcare team will know that you are receiving the study medicine. It's also an 'extension study', which is like a follow-on from an earlier study. This is important because it helps scientists learn about any lasting benefits or potential side effects of the medicine when used for a longer time.
Key takeaways
- This study is testing a medicine (PF-07868489) for high blood pressure in the lungs (PAH).
- It's for people who have already used this medicine in a previous study.
- The main aims are to check long-term safety and whether the medicine keeps working.
- Both you and your medical team will know you are receiving the study medicine.
- You need to be over 18 and meet specific health criteria to join.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is for adults, aged 18 or over. You must have already taken part in an earlier study involving the medicine PF-07868489 and completed it as planned. This includes having finished all the required treatment and checks.
You need to be able to attend all scheduled appointments, follow the treatment plan, have blood tests, and stick to any lifestyle advice given during the study. It's important that your PAH hasn't got worse or caused you to be admitted to hospital during your previous study with this medicine. Also, you shouldn't be waiting for a lung transplant or any other surgery for your PAH.
You won't be able to join if you have another serious health problem that your study doctor thinks would make it unsafe for you to take part. This includes having a liver-related lung condition called hepato-pulmonary syndrome, now or in the past. You also shouldn't be currently taking certain diabetes medicines called 'GLP-1 agonists'.
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.
- Are you 18 years old or older?
- Have you already completed an earlier study using the medicine PF-07868489?
- Has your PAH not worsened or led to hospitalisation during that previous study?
- Are you able to attend all study appointments and follow the treatment plan?
- Do you not have a liver-related lung condition (hepato-pulmonary syndrome)?
- Are you not currently taking GLP-1 agonist medicines?
What does participation involve?
If you join this study, you will continue to receive the study medicine, PF-07868489. You will need to attend all scheduled visits to the clinic, which will involve regular health check-ups, having blood tests, and other assessments to monitor your health and how the medicine is affecting you. You'll need to follow the treatment plan carefully and stick to any advice about your diet or lifestyle. The total duration of your participation will depend on the study design, but generally, extension studies aim to gather long-term information.
Potential risks and benefits
Locations (48)
- UC Davis Health Medical CenterVerified postcodeSacramento, United States· Not yet recruiting
- UCSF Health St. Mary's HospitalVerified postcodeSan Francisco, United States· Recruiting
- Heart and Vascular CenterVerified postcodeSan Francisco, United States· Recruiting
- University of Colorado Anschutz Medical CampusVerified postcodeAurora, United States· Recruiting
- Norton HospitalVerified postcodeLouisville, United States· Recruiting
- Norton Pulmonary SpecialistsVerified postcodeLouisville, United States· Recruiting
- Mount Sinai HospitalVerified postcodeNew York, United States· Not yet recruiting
- Clinical Trials Unit at Eastowne Medical Office BuildingVerified postcodeChapel Hill, United States· Recruiting
- Pulmonary Hypertension Clinical Trials Office at EastowneVerified postcodeChapel Hill, United States· Recruiting
- Pulmonary Specialty Clinic at Eastowne Medical Office BuildingVerified postcodeChapel Hill, United States· Recruiting
- UNC HospitalsVerified postcodeChapel Hill, United States· Recruiting
- Rhode Island HospitalVerified postcodeProvidence, United States· Recruiting
Common questions
What is Pulmonary Arterial Hypertension (PAH)?
PAH is a condition where the blood pressure in the arteries leading from your heart to your lungs is too high, making your heart work harder.
Why is this an 'extension study'?
It's an extension study because it allows people who have already tried the medicine PF-07868489 in a previous study to continue taking it, so researchers can learn about its long-term effects and safety.
Will I know if I'm getting the medicine?
Yes, this is an 'open-label' study, which means both you and your doctor will know that you are receiving the study medicine, PF-07868489.
Who can join this study?
This study is for adults over 18 who have already completed an earlier study with PF-07868489 and who meet other specific health requirements.
Do I have to keep taking part if I change my mind?
No, taking part in a study is always voluntary. You can decide to leave the study at any time, and it won't affect your regular medical care.
How to find out more
Pfizer CT.gov Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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