B1481045 Phase III Study of PF-04950615 & Hyperlipidemia/Dyslipidemia.
Research type
Research Study
Full title
A 52 WEEK, PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF PF-04950615 IN SUBJECTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA AT RISK OF CARDIOVASCULAR EVENTS
IRAS ID
164184
Contact name
Jasper Trevelyan
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2014-000478-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Cardiovascular disease (CVD) due to atherosclerosis (narrowing and hardening of the arteries) continues to be the leading single cause of death in industrialised countries. High serum lipid levels, and especially high low density lipoprotein cholesterol (LDL-C) levels, have been strongly linked with cardiovascular disease risks by numerous studies. Moreover, large prospective clinical outcome trials have demonstrated that lowering LDL-C decreases cardiovascular morbidity and mortality.
Despite the availability of lipid lowering therapies such as statins and ezetimibe, a significant percentage of subjects at high risk for CVD fail to reach or maintain their LDL-C treatment target.
PF04950615 is a drug being developed for the treatment of primary hyperlipidaemia and mixed dyslipidaemia (elevated levels of lipids in the blood).
This study is a 52 week, Phase 3, double blind, placebo controlled, randomized, stratified, parallel group, multi centre clinical trial designed to compare the efficacy, safety and tolerability of PF 04950615 150 mg Subcutaneously every 2 weeks to placebo for LDL-C lowering in subjects with primary hyperlipidaemia or mixed dyslipidaemia at high or very high risk for CV events.
The study will randomize a total of approximately 690 subjects in a 2:1 ratio (approximately 460 and 230 subjects in the PF-04950615 arm and placebo arm respectively), who will receive study drug for 12 months.
There are 11 sites taking part in this study in the UK.
Throughout the study, participants will undergo physical examinations, vital signs and ECG; neurological panel,blood and urine will be taken for various tests; instruction on self-injection and diet and therapeutic lifestyle recommendations will be provided.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
14/EE/1203
Date of REC Opinion
2 Dec 2014
REC opinion
Further Information Favourable Opinion