Pfizer B1481038 - Phase 3 PF-04950615 in Reducing Major CV Events
Research type
Research Study
Full title
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
IRAS ID
146569
Contact name
Mark Caulfield
Contact email
Sponsor organisation
Pfizer Inc, 235 East 42nd Street, New York, NY10017-5755
Eudract number
2013-002795-41
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Cardiovascular disease (CVD) due to atherosclerosis (a condition that causes the arteries to be clogged up by fat) continues to be the leading single cause of death in industrialised countries. High low density lipoprotein cholesterol (LDL-C – an unhealthy type of fat) levels, have been demonstrated to correlate with cardiovascular disease risks. Moreover, clinical trials have demonstrated that lowering LDL-C decreases cardiovascular morbidity and mortality. Despite the availability of lipid lowering therapies such as statins and ezetimibe, some patients who are at high risk for CVD fail to reach or maintain their LDL-C treatment target.
PF-04950615 is a drug being developed for the treatment of primary hyperlipidemia and mixed dyslipidemia (elevated levels of lipids in the blood) and cardiovascular risk reduction.
This is an event driven, Phase 3, double-blind, placebo-controlled, randomised, parallel group, multi-centre clinical trial designed to compare the efficacy, safety and tolerability of PF-04950615 150 mg administered by injection every two weeks to placebo in reducing the occurrence of major cardiovascular events in subjects at high risk.
Participants will have a screening visit, followed by a run-in period of approximately 6 weeks, during which they will be assessed with respect to eligibility and compliance. Only participants who meet all eligibility criteria will be randomised and will enter a 48-month treatment period. The duration may be shorter however as the study will be terminated when the endpoints have been met or 12 months after the last participant has entered.
Participants will be randomized to receive PF-04950615 or placebo (by injection every two weeks). Approximately 12,000 participants will be randomised at approximately 700 sites in 30 countries.
Throughout the study, participants will undergo physical examinations, vital signs and ECG; blood and urine will be taken for various tests; instruction on self-injection and diet and therapeutic lifestyle recommendations will be provided.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/0033
Date of REC Opinion
14 Feb 2014
REC opinion
Further Information Favourable Opinion