CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 184 enrolled
Drug / intervention
Bococizumab (PF-04950615;RN316) +3 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/NCT02135029
NCT02135029Phase 3Completed
CompareCT.gov

A Phase 3, Double-blind, Double-dummy, Randomized, Placebo And Active Controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Dyslipidemia Who Are Intolerant To Statins

Pfizer·interventional·Posted May 9, 2014·Updated Dec 14, 2017

In Brief

A Phase 3 clinical trial evaluating Bococizumab (PF-04950615;RN316), Atorvastatin, and 2 other interventions for Hyperlipidemia. Completed, enrolled 184 participants across 40 sites in 2 countries.

Detailed Summary

This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 9, 2014
Enrollment StartJun 1, 2014
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.1 years ago

Interventions

Bococizumab (PF-04950615;RN316)drug

150 mg every 2 weeks by subcutaneous injection for 24 weeks

Atorvastatindrug

Atorvastatin PO QD

Placebo for Bococizumab (PF-04950615;RN316)other

150 mg every 2 weeks by subcutaneous injection for 24 weeks

Placebo for atorvastatinother

PO QD