Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

Tracking Information
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; (submitted: February 4, 2014)	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; (submitted: February 4, 2014)	Actual Value and Change from Baseline in LDL-C [ Time Frame: Baseline, Week 12 and 16 ]; Actual Value, Change from Baseline and Percent Change from Baseline in Lipid parameters [ Time Frame: Baseline, Week 12 and 16 ]Total Cholesterol (TC), ApoB, ApoA-I, ApoA-II, Lp(a), High Density Lipoprotein Cholesterol, VLDL-C, Triglyceride, Non-HDL-cholesterol, TC/HDL-C ratio and ApoB/ApoA-I ratio.; Proportion of subjects having LDL-C less than particular limits (<100 mg/dL, <70 mg/dL, <40 mg/dL, <25 mg/dL, <10 mg/dL) [ Time Frame: Week 12 and 16 ]; Anti-drug antibody (ADA) [ Time Frame: Week 24 ]; Area Under the Curve (AUC) [ Time Frame: Week 20 ]; Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Week 20 ]; Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Week 20 ]; Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Week 20 ]; Plasma Decay Half-Life (t1/2) [ Time Frame: Week 20 ]; Plasma concentration of PCSK9 [ Time Frame: Week 20 ]
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
Condition ICMJE	Hypercholesterolemia
Intervention ICMJE	Drug: Bococizumab (PF-04950615;RN316) Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week; Drug: Bococizumab (PF-04950615;RN316) Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week; Drug: Bococizumab (PF-04950615;RN316) Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week; Drug: Placebo Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week; Drug: Ezetimibe Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open); Drug: Bococizumab (PF-04950615;RN316) 50 mg Q14D SC for 16 week; Drug: Bococizumab (PF-04950615;RN316) 100 mg Q14D SC for 16 week; Drug: Bococizumab (PF-04950615;RN316) 150 mg Q14D SC for 16 week; Drug: Placebo Placebo Q14D SC for 16 week
Study Arms	Experimental: 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. Interventions: Drug: Bococizumab (PF-04950615;RN316) Drug: Bococizumab (PF-04950615;RN316) Drug: Bococizumab (PF-04950615;RN316) Drug: Placebo Drug: Ezetimibe; Experimental: 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. Interventions: Drug: Bococizumab (PF-04950615;RN316) Drug: Bococizumab (PF-04950615;RN316) Drug: Bococizumab (PF-04950615;RN316) Drug: Placebo
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 9, 2015)	218
Original Estimated Enrollment ICMJE; (submitted: February 4, 2014)	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: Subjects whose LDL-C is not controlled by a stable dose of atorvastatin (Population A).; Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled (Population B). Exclusion Criteria: Severe acute or chronic medical or psychiatric condition or laboratory abnormality.; 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.
Sex/Gender	Sexes Eligible for Study: All
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	Study Director: Pfizer CT.gov Call Center Pfizer
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