At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 711 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, 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 711 participants across 103 sites in 9 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
CountriesAustralia, Canada, Czechia, Germany, Hong Kong, Italy, Poland, South Korea, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedOct 2013
Primary CompletionApr 2016
TodayJul 2026
First PostedOct 24, 2013
Enrollment StartOct 1, 2013
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 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