Trials / Completed
CompletedNCT01968980
A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 370 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
- 2013-10-23
- Primary completion
- 2016-04-15
- Completion
- 2016-04-15
- First posted
- 2013-10-24
- Last updated
- 2017-06-26
- Results posted
- 2017-05-19
Locations
88 sites across 11 countries: United States, Bulgaria, Canada, Finland, Italy, Netherlands, Norway, Poland, South Africa, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01968980. Inclusion in this directory is not an endorsement.