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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Maebashi Hirosegawa Clinic
Maebashi, Gunma, 371-0022 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02055976
Pfizer
Completed
Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

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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 SummaryThe 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE 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  ICMJE
  • 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 *


*   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  ICMJE January 2015
Actual Primary Completion DateJanuary 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  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02055976
Other Study ID Numbers  ICMJE B1481036
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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