A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects

NCT01720537

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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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
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- On stable daily doses of a statin for 45 days prior to receiving study treatment.

- Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization.

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


- History of a cardiovascular or cerebrovascular event or procedure within one year of
randomization.


- Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects
Official Title  ICMJE A Phase I, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Ascending Doses Of PF-05335810 In Hypercholesterolemic Subjects, With One, Open-Label, Multiple Fixed Dosage Cohort
Brief Summary This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Biological: PF-05335810 Dose A
    Single SC Injection
  • Biological: PF-05335810 Dose B
    Single Subcutaneous Injection(s)
  • Biological: Placebo
    Single Subcutaneous Injection(s)
  • Biological: PF-05335810 Dose B
    Single Intravenous Infusion
  • Biological: Placebo
    Single Intravenous Infusion
  • Biological: PF-04950615 Dose A
    Single Subcutaneous Injection(s)
  • Biological: PF-04950615 Dose A
    Single Intravenous Infusion
  • Biological: PF-05335810 Dose C
    Single Subcutaneous Injection(s)
  • Biological: PF-05335810 Dose C
    Single Intravenous Infusion
  • Biological: PF-04950615
    Single Subcutaneous Injection(s)
  • Biological: PF-05335810 Dose D
    Single Subcutaneous Injection(s)
  • Biological: PF-05335810 Dose E
    Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
  • Biological: PF-05335810 Dose D
    Single Intravenous Infusion
Study Arms  ICMJE
  • Experimental: Cohort 1
    Intervention: Biological: PF-05335810 Dose A
  • Experimental: Cohort 2
    Interventions:
    • Biological: PF-05335810 Dose B
    • Biological: Placebo
    • Biological: PF-05335810 Dose B
    • Biological: Placebo
    • Biological: PF-04950615 Dose A
    • Biological: PF-04950615 Dose A
  • Experimental: Cohort 3
    Interventions:
    • Biological: PF-05335810 Dose C
    • Biological: Placebo
    • Biological: PF-05335810 Dose C
    • Biological: Placebo
    • Biological: PF-04950615
  • Experimental: Cohort 4
    Interventions:
    • Biological: PF-05335810 Dose D
    • Biological: Placebo
  • Experimental: Cohort 5
    Intervention: Biological: PF-05335810 Dose E
  • Experimental: Cohort 6
    Interventions:
    • Biological: PF-05335810 Dose D
    • Biological: Placebo
Publications * Not Provided

*   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: November 30, 2018)
133
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2012)
110
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • On stable daily doses of a statin for 45 days prior to receiving study treatment.
  • Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization.

Exclusion Criteria:

  • History of a cardiovascular or cerebrovascular event or procedure within one year of randomization.
  • Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01720537
Other Study ID Numbers  ICMJE B3091001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018

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