CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 746 enrolled
Drug / intervention
Bococizumab (PF-04950615; RN316) +1 moredrug
Likely dose
Bococizumab (PF-04950615; RN316) 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02100514
NCT02100514Phase 3Completed
CompareCT.gov

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

Pfizer·interventional·Posted Apr 1, 2014·Updated Jul 31, 2018

In Brief

A Phase 3 clinical trial evaluating Bococizumab (PF-04950615; RN316) and Placebo for Hyperlipidemia. Completed, enrolled 746 participants across 223 sites in 12 countries.

Detailed Summary

This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesCanada, Czechia, Finland, Netherlands, Norway, Poland, Puerto Rico, Singapore, South Korea, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 1, 2014
Enrollment StartOct 28, 2014
Primary CompletionJul 15, 2016
Study CompletionJul 10, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.3 years ago

Interventions

Bococizumab (PF-04950615; RN316)drug

150 mg every 2 weeks, subcutaneous injection for 52 weeks.

Placeboother

Subcutaneous injection every 2 weeks for 52 weeks.