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Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C \>/= 100 mg/dL (2.6 mmol/L) or non-HDL-C \>/=130 mg/dL (3.4 mmol/L).
The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents. These indicated that bococizumab was not likely to provide value to patients, physicians, or shareholders. The decision was not based on a recommendation by the independent Data Monitoring Committee to stop the program.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ernest Hendrix, MD, PC
Athens, Alabama, United States
North Alabama Research Center, LLC
Athens, Alabama, United States
Central Alabama Research
Birmingham, Alabama, United States
Clinical Research Advantage, Inc./Simon Williamson Clinic
Birmingham, Alabama, United States
The Kirklin Clinic
Birmingham, Alabama, United States
Birmingham Heart Clinic, P.C.
Birmingham, Alabama, United States
University of Alabama at Birmingham (Drug Shipment)
Birmingham, Alabama, United States
Appalachian Cardiovascular Associates
Fort Payne, Alabama, United States
Fundamental Research, LLC
Gulf Shores, Alabama, United States
Avant Research Associates, LLC
Guntersville, Alabama, United States
Start Date
October 29, 2013
Primary Completion Date
April 3, 2017
Completion Date
April 3, 2017
Last Updated
May 1, 2019
10,564
ACTUAL participants
bococizumab (PF-04950615)
DRUG
Placebo
DRUG
Lead Sponsor
Pfizer
NCT03372733
NCT07241390
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06909773