This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.
- Treated with a statin
- Fasting LDL-C >=100 mg/dL and triglyceride
- High or very high risk of incurring a cardiovascular event
- Pregnant or breastfeeding females
- Cardiovascular or cerebrovascular event or procedure within 90 days
- Congestive heart failure NYHA class IV
- Poorly controlled hypertension
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events | |||
| Official Title ICMJE | 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 Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events | |||
| Brief Summary | This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
| Condition ICMJE | Hyperlipidemia | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 746 | |||
| Original Estimated Enrollment ICMJE | 939 | |||
| Actual Study Completion Date ICMJE | July 10, 2017 | |||
| Actual Primary Completion Date | July 15, 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada, Czechia, Finland, Korea, Republic of, Netherlands, Norway, Poland, Puerto Rico, Singapore, Sweden, United Kingdom, United States | |||
| Removed Location Countries | Czech Republic | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT02100514 | |||
| Other Study ID Numbers ICMJE | B1481045 SPIRE-LL ( Other Identifier: Alias Study Number ) 2014-000478-20 ( EudraCT Number ) | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | July 2018 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
