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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02055976
First received: January 22, 2014
Last updated: March 2, 2016
Last verified: March 2016
History of Changes

January 22, 2014
March 2, 2016
March 2014
January 2015   (final data collection date for primary outcome measure)
Percent Change from Baseline in LDL-C at Week 12 and 16 [ Time Frame: Week 12 and 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02055976 on ClinicalTrials.gov Archive Site
  • Actual Value and Change from Baseline in LDL-C [ Time Frame: Baseline, Week 12 and 16 ] [ Designated as safety issue: No ]
  • Actual Value, Change from Baseline and Percent Change from Baseline in Lipid parameters [ Time Frame: Baseline, Week 12 and 16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Anti-drug antibody (ADA) [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Area Under the Curve (AUC) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Plasma concentration of PCSK9 [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
January 2015
January 2015   (final data collection date for primary outcome measure)

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.
Both
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT02055976
B1481036
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP