A Study to Learn About the Study Medicine Called PF-07328... | NCT06991257

ID	Type	Description	Link
2024-518438-94-00	Registry Identifier	CTIS (EU)

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARM 1	Placebo Comparator	Placebo Participants will receive Placebo for up to 36 weeks	Drug: Placebo
ARM 2	Experimental	Low dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks	Drug: Low Dose PF-07328948
ARM 3	Experimental	Medium dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks	Drug: Medium Dose PF-07328948
ARM 4	Experimental	High dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks	Drug: High Dose PF-07328948

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	ARM 1	ARM 1
Low Dose PF-07328948

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Clinical Events	Adjudicated cardiovascular death and worsening heart failure events through 36 weeks.	over 36 weeks
Change From Baseline in 6-Minute Walk Test (6MWD)	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.	Baseline, week 36 post-dose
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS)	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.	Baseline, week 36

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE that, at any dose, results in 1 or more of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events.

Eligibility Module

Name	Role	Phone	Extension	Email
Pfizer CT.gov Call Center	Contact	1-800-718-1021		ClinicalTrials.gov_Inquiries@pfizer.com

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
National Heart Institute	Recruiting	Beverly Hills	California	90211	United States

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D003271	Contraceptive Agents, Female
D003270	Contraceptive Agents
D012102	Reproductive Control Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D045506	Therapeutic Uses