Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects
NCT ID: NCT02055976
Last Updated: 2019-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
218 participants
INTERVENTIONAL
2014-03-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Population A
A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups.
Bococizumab (PF-04950615;RN316)
Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week
Bococizumab (PF-04950615;RN316)
Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week
Bococizumab (PF-04950615;RN316)
Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week
Placebo
Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week
Ezetimibe
Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)
Population B
A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups.
Bococizumab (PF-04950615;RN316)
50 mg Q14D SC for 16 week
Bococizumab (PF-04950615;RN316)
100 mg Q14D SC for 16 week
Bococizumab (PF-04950615;RN316)
150 mg Q14D SC for 16 week
Placebo
Placebo Q14D SC for 16 week
Interventions
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Bococizumab (PF-04950615;RN316)
Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week
Bococizumab (PF-04950615;RN316)
Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week
Bococizumab (PF-04950615;RN316)
Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week
Placebo
Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week
Ezetimibe
Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)
Bococizumab (PF-04950615;RN316)
50 mg Q14D SC for 16 week
Bococizumab (PF-04950615;RN316)
100 mg Q14D SC for 16 week
Bococizumab (PF-04950615;RN316)
150 mg Q14D SC for 16 week
Placebo
Placebo Q14D SC for 16 week
Eligibility Criteria
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Inclusion Criteria
* Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled (Population B).
Exclusion Criteria
* Pregnant females; breastfeeding females; males and females of childbearing potential; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
* Subjects who were administered or prior exposed to PF-04950615 and/or anti-body targeting PCSK9.
20 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Maebashi Hirosegawa Clinic
Maebashi, Gunma, Japan
Yokohama Minoru Clinic
Yokohama, Kanagawa, Japan
Heishinkai Medical Group Incorporated OCROM Clinic
Suita, Osaka, Japan
Meiwa Hospital
Chiyoda-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan
Heishinkai Medical Group Incorporated ToCROM Clinic
Shinjuku-ku, Tokyo, Japan
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, Japan
Oda Clinic
Shinjuku-ku, Tokyo, Japan
Sekino Hospital
Toshima-ku, Tokyo, Japan
Countries
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References
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Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
Yokote K, Suzuki A, Li Y, Matsuoka N, Teramoto T. Pharmacokinetics and exploratory efficacy biomarkers of bococizumab, an anti-PCSK9 monoclonal antibody, in hypercholesterolemic Japanese subjects . Int J Clin Pharmacol Ther. 2019 Dec;57(12):575-589. doi: 10.5414/CP203418.
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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1481036
Identifier Type: -
Identifier Source: org_study_id
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