At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 370 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 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 Heterozygous Familial Hypercholesterolemia
In Brief
A Phase 3 clinical trial evaluating Bococizumab (PF-04950615;RN316) and Placebo for Heterozygous Familial Hypercholesterolemia. Completed, enrolled 370 participants across 88 sites in 11 countries.
Detailed Summary
This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Canada, Finland, Italy, Netherlands, Norway, Poland, South Africa, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedOct 2013
Primary CompletionApr 2016
TodayJul 2026
First PostedOct 24, 2013
Enrollment StartOct 23, 2013
Primary CompletionApr 15, 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