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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
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
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%).

NCT01720537
Pfizer
Completed
A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects

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A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Hypercholesterolemia
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
October 2013
October 2013   (Final data collection date for primary outcome measure)

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%).
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01720537
B3091001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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