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Also known as Oral [14C]PF-07328948, Low Dose PF-07328948
PF-07328948 · 1 trial · 1 indication
Adjudicated cardiovascular death and worsening heart failure events through 36 weeks.
A submaximal exercise test that measures the distance the participant can walk within prescribed time of 6 minutes. Participants are asked to perform the test at a pace comfortable to them with as many breaks as needed. The total distance walked is recorded.
KCCQ is a 23-item heart-failure specific questionnaire quantified into the following scores: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life, and self-efficacy, total symptom score, overall summary score, and clinical summary score. To facilitate interpretation, all scores are presented on a scale of 0 to 100 points, with lower scores indicating more severe symptoms and/or limitations, and a score of 100 indicating no symptoms, no limitations, and excellent quality of life.
| Arm | Type | Description |
|---|---|---|
| ARM 1 | PLACEBO_COMPARATOR | Placebo Participants will receive Placebo for up to 36 weeks |
| ARM 2 | EXPERIMENTAL | Low dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks |
| ARM 3 | EXPERIMENTAL | Medium dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks |
| ARM 4 | EXPERIMENTAL | High dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | ARM 1 |
| Low Dose PF-07328948 | DRUG | ARM 2 |
| Medium Dose PF-07328948 | DRUG | ARM 3 |
| High Dose PF-07328948 | DRUG | ARM 4 |
This study is seeking participants who are: Key Inclusion Criteria include: * aged 18 years to \< 80 years * clinically confirmed to have a diagnosis of heart failure for at least 3 months * New York Heart Association Class II-IV symptoms * left ventricular ejection fraction greater than 40% * Kan...
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PF-07328948 is an investigational small molecule medicine being developed by Pfizer for the treatment of heart failure. It is currently in Phase 2 clinical development and has not been approved by any regulatory authority. It is being studied in adults aged 18 years and older with heart failure.
PF-07328948 is being studied for the treatment of heart failure. It is an investigational therapy, meaning it is not yet approved for use in patients, and its safety and efficacy in heart failure are still being evaluated in clinical trials.
PF-07328948 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is running the clinical development program for this investigational heart failure candidate.
PF-07328948 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 2 program is currently recruiting participants with heart failure.
PF-07328948 is being evaluated in the BRANCH-HF trial, registered as NCT06991257, titled a study to learn about the study medicine called PF-07328948 in adults with heart failure. The Phase 2 trial is recruiting and plans to enroll 620 participants across the United States, Brazil, Bulgaria, Canada, China, Czechia, France, Hungary, Japan, Poland, Puerto Rico, Spain, and the United Kingdom.
Yes. PF-07328948 is also referred to as Oral [14C]PF-07328948 and Low Dose PF-07328948. These names refer to the same investigational Pfizer compound being studied in heart failure, so searches using any of these terms point to the same drug candidate.
The Phase 2 BRANCH-HF trial of PF-07328948 is randomized, double blind, and placebo controlled. It plans to enroll 620 adults aged 18 years and older with heart failure, includes both sexes, does not enroll healthy volunteers, and is currently recruiting across multiple countries.