Trials / Completed
CompletedNCT01968967
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, Long-term 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
- 2,139 (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
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
- 2013-10-29
- Primary completion
- 2016-07-05
- Completion
- 2017-07-10
- First posted
- 2013-10-24
- Last updated
- 2018-07-31
- Results posted
- 2017-07-24
Locations
249 sites across 12 countries: United States, Canada, Colombia, France, Hungary, Lithuania, Mexico, Romania, Russia, Spain, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT01968967. Inclusion in this directory is not an endorsement.