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A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins

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NCT01342211

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Orange County Research Center
Tustin, California, 92780 United States
See other locations
Contact
1-800-718-1021
[email protected].com
Related Links
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+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- On a stable daily dose of atorvastatin, rosuvastatin or simvastatin.

- Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C
greater than 100 mg/dL and fasting TG less than 400 mg/dL

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 during the past
year.

- Poorly controlled type 1 or type 2 diabetes mellitus.

- Poorly controlled hypertension.

NCT01342211
Pfizer
Completed
A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins

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A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins
A Phase 2, Double-blind, Placebo-controlled, Randomized Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Multiple Intravenous Doses In Hypercholesterolemic Subjects On High Doses Of Atorvastatin, Rosuvastatin Or Simvastatin.
This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Dyslipidemia
  • Biological: Placebo
    Intravenous placebo monthly during treatment phase.
  • Drug: Statin
    Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
  • Biological: PF-04950615 (RN316)
    Intravenous 10mg/mL based on weight monthly during treatment phase.
  • Drug: Satin
    Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
  • Placebo Comparator: Treatment A
    Interventions:
    • Biological: Placebo
    • Drug: Statin
  • Experimental: Treatment B
    Interventions:
    • Biological: PF-04950615 (RN316)
    • Drug: Statin
  • Experimental: Treatment C
    Interventions:
    • Biological: PF-04950615 (RN316)
    • Drug: Statin
  • Experimental: Treatment D
    Interventions:
    • Biological: PF-04950615 (RN316)
    • Drug: Satin
  • Experimental: Treatment E
    Interventions:
    • Biological: PF-04950615 (RN316)
    • Drug: Statin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
June 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • On a stable daily dose of atorvastatin, rosuvastatin or simvastatin.
  • Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C greater than 100 mg/dL and fasting TG less than 400 mg/dL

Exclusion Criteria:

  • History of a cardiovascular or cerebrovascular event or procedure during the past year.
  • Poorly controlled type 1 or type 2 diabetes mellitus.
  • Poorly controlled hypertension.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01342211
B1481005
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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