NCT01968954

Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 711 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Bococizumab (PF-04950615;RN316)	150 mg every 2 weeks, subcutaneous injection, 12 months
OTHER	Placebo	subcutaneous injection, every 2 weeks for 12 months

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-10-24
• Last updated: 2017-05-17
• Results posted: 2017-05-17

Locations

103 sites across 9 countries: United States, Australia, Canada, Czechia, Germany, Hong Kong, Italy, Poland, South Korea