CompletedPhase 3

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events

United States2,139 participantsStarted 2013-10-29

Plain-language summary

This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Treated with a statin. * Fasting LDL-C \> 70 mg/dL and triglyceride \<=400 mg/dL. * High or very high risk of incurring a cardiovascular event. Exclusion Criteria: * Pregnant or breastfeeding females. * Cardiovascular or cerebrovascular event of procedures during the past 30 days. * Congestive heart failure NYHA class IV. * Poorly controlled hypertension.

What they're measuring

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Timeframe: Baseline, Week 12

Trial details

NCT IDNCT01968967

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-07-05

Results submitted2017-06-22

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