At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,139 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.
A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
In Brief
A Phase 3 clinical trial evaluating Bococizumab (PF-04950615; RN316) and Placebo for Hyperlipidemia. Completed, enrolled 2,139 participants across 249 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesCanada, Colombia, France, Hungary, Lithuania, Mexico, Romania, Russia, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 2013
Enrollment StartOct 2013
Primary CompletionJul 2016
Study CompletionJul 2017
TodayJul 2026
First PostedOct 24, 2013
Enrollment StartOct 29, 2013
Primary CompletionJul 5, 2016
Study CompletionJul 10, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.7 years ago
Interventions
Bococizumab (PF-04950615; RN316)drug
150 mg every 2 weeks, subcutaneous injection, 12 months
Placeboother
subcutaneous injection every 2 weeks for 12 months