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Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia

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NCT01243151

Last updated on March 25, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Culver City, California, 90232 United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia, Dyslipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- LDL-C must be greater or equal to 130 mg/dl

- BMI must be between 18.5 and 40 kg/m2

- Japanese volunteers must have 4 Japanese grand parents born in Japan

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

- History of cardiovascular or cerebrovascular event during the past year.

- Poorly controlled type 1 or type 2 diabetes mellitus

- Subjects who have taken lipid lowering therapies within the last 3 months of
screening.

NCT01243151
Pfizer
Completed
Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia

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Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia
A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of PF-04950615 (RN316) In Healthy Adult Subjects With Hypercholesterolemia
The primary objective of this study is to evaluate the safety and tolerability of repeated doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an investigational drug that is currently being studied as a lipid lowering agent.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Dyslipidemia
Biological: PF-04950615 (RN316)
Infusion every week
  • Placebo Comparator: A
    Intervention: Biological: PF-04950615 (RN316)
  • Experimental: B
    Intervention: Biological: PF-04950615 (RN316)
  • Experimental: C
    Intervention: Biological: PF-04950615 (RN316)
  • Experimental: D
    Intervention: Biological: PF-04950615 (RN316)
  • Experimental: E
    Intervention: Biological: PF-04950615 (RN316)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • LDL-C must be greater or equal to 130 mg/dl
  • BMI must be between 18.5 and 40 kg/m2
  • Japanese volunteers must have 4 Japanese grand parents born in Japan

Exclusion Criteria:

  • History of cardiovascular or cerebrovascular event during the past year.
  • Poorly controlled type 1 or type 2 diabetes mellitus
  • Subjects who have taken lipid lowering therapies within the last 3 months of screening.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01243151
B1481009
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

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

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