NCT02135029

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Bococizumab (PF-04950615;RN316)	150 mg every 2 weeks by subcutaneous injection for 24 weeks
DRUG	Atorvastatin	Atorvastatin PO QD
OTHER	Placebo for Bococizumab (PF-04950615;RN316)	150 mg every 2 weeks by subcutaneous injection for 24 weeks
OTHER	Placebo for atorvastatin	PO QD

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-05-09
• Last updated: 2017-12-14
• Results posted: 2017-12-14

Locations

40 sites across 2 countries: United States, Canada