Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects
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ClinicalTrials.gov Identifier: NCT02055976 |
Recruitment Status
:
Completed
First Posted
: February 5, 2014
Last Update Posted
: March 30, 2016
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
Tracking Information | ||||
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First Submitted Date ICMJE | January 22, 2014 | |||
First Posted Date ICMJE | February 5, 2014 | |||
Last Update Posted Date | March 30, 2016 | |||
Study Start Date ICMJE | March 2014 | |||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Percent Change from Baseline in LDL-C at Week 12 and 16 [ Time Frame: Week 12 and 16 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT02055976 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects | |||
Official Title ICMJE | A Phase 2 Double Blind, Parallel Group, Placebo Controlled, Randomized, Dose Ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Twice Monthly Subcutaneous Doses In Hypercholesterolemic Japanese Subjects Who Are Receiving A Stable Dose Of Atorvastatin Or Treatment Naïve. | |||
Brief Summary | The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Hypercholesterolemia | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Yokote K, Kanada S, Matsuoka O, Sekino H, Imai K, Tabira J, Matsuoka N, Chaudhuri S, Teramoto T. Efficacy and Safety of Bococizumab (RN316/PF-04950615), a Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, in Hypercholesterolemic Japanese Subjects Receiving a Stable Dose of Atorvastatin or Treatment-Naive - Results From a Randomized, Placebo-Controlled, Dose-Ranging Study. Circ J. 2017 Sep 25;81(10):1496-1505. doi: 10.1253/circj.CJ-16-1310. Epub 2017 May 23. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
218 | |||
Original Estimated Enrollment ICMJE |
216 | |||
Actual Study Completion Date | January 2015 | |||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02055976 | |||
Other Study ID Numbers ICMJE | B1481036 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |