Open-Label Extension Study for Participants with PAH, Previously Participated in a CTA PF-07868489
Research type
Research Study
Full title
A PHASE 2, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-07868489 ADMINISTERED TO ADULT PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION
IRAS ID
1012439
Contact name
Helen Joe
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2025-521155-23
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This is an open-label extension study for participants with Pulmonary Arterial Hypertension (PAH) who have previously participated in a clinical study with PF-07868489.
The purpose of this study is to learn about the long-term safety, tolerability and effects of the study medicine (PF-07868489) for the possible treatment of PAH. PAH is a condition in which there is high blood pressure in the arteries that carry blood from the heart to the lungs. This high pressure makes it harder for the heart to pump blood through those lungs, potentially damaging the right side of the heart.
This study is seeking participants who are aged 18 years or older at screening of the qualifying study and completed the required treatment period and end of study assessments, and willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
All participants be involved in this study for up to 2 years and get the study medicine (PF-07868489) every 4 weeks up to 104 weeks as 1 or more shots under the skin by the study site staff at every study site visits. Participants will take the study medicine in addition to continuing to be treated with at least 2 PAH treatments that they are already taking to treat their condition.The study will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.
The following assessments/tests will be done during the study to monitor participants’ health during the study and to see what effects the study treatment will have on them – blood/urine tests, ECGs, heart rate, blood pressure, breathing rate, use of a digital tool/tablet for the collection of answers to patient questions, a 6-minute walk test, and a right heart catheterization.
REC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0666
Date of REC Opinion
24 Oct 2025
REC opinion
Further Information Favourable Opinion