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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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 is an open-label study. Which means that both the healthcare providers and the study participants are aware of the medicine being given. This study is also an extension study with study medicine (PF-07868489). An extension study allows patients from an earlier clinical study (also called as qualifying study) to continue participating to assess long-term benefits and safety of the medicine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged 18 years or older at screening of the previous study and completed the required treatment duration with PF-07868469 and other assessments at the end of that study.

willing and able to abide with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

do not have worsening or hospitalization for worsening PAH during the qualifying study.

not on placement for a surgery to replace any tissue or part of the body (transplant), and planned surgery for PAH.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • PF-07868489

    Drug

    Participants will receive subcutaneous doses of PF-07868489 every 4 weeks

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Open LabelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
Baseline up to week 111
2

Number of Participants With Change From Baseline in Laboratory Tests Results

Time frame
Baseline up to week 111
3

Number of Participants With Vital Sign Abnormalities

Time frame
Baseline up to week 111

Secondary outcomes

1

Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters

Time frame
Baseline up to week 111
2

Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration

Time frame
Baseline up to week 104
3

Minimum Observed Plasma Trough Concentration (Cmin), as data permits

Time frame
Baseline up to week 111
4

Incidence of Anti-Drug Antibody (ADA)

Time frame
Baseline up to week 111

Other outcomes

Sponsors and contacts

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