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A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins

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NCT01350141

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216 United States
See other locations
Contact
1-800-718-1021
[email protected]
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

- Body Mass Index (BMI) of 18.5 to 40 kg/m2

- On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or
rosuvastatin 40 mg for a minimum of 45 days prior to Day 1.

- Lipids meet the following criteria twice during screening period:

- Fasting LDL C = or > 80 mg/dL;

- Fasting TG

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 (eg, MI, stroke,
TIA, angioplasty) during the past year.

- Poorly controlled type 1 or type 2 diabetes mellitus.

- Poorly controlled hypertension.

- Fasting triglycerides > 400 mg/dL

- 12 lead ECG demonstrating QTcFF >455 msec at screening.

NCT01350141
Pfizer
Completed
A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins

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A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum 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 Maximum Dose Of Atorvastatin Or Rosuvastatin.
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Dyslipidemia
  • Other: Placebo
    An infusion lasting approximately 60 minutes
  • Drug: PF-04950615 (RN316)
    An infusion lasting approximately 60 minutes
  • Placebo Comparator: Treatment A
    Intervention: Other: Placebo
  • Experimental: Treatment B
    Intervention: Drug: PF-04950615 (RN316)
  • Experimental: Treatment C
    Intervention: Drug: 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
46
June 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body Mass Index (BMI) of 18.5 to 40 kg/m2
  • On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 45 days prior to Day 1.
  • Lipids meet the following criteria twice during screening period:
  • Fasting LDL C = or > 80 mg/dL;
  • Fasting TG < 400 mg/dL.

Exclusion Criteria:

  • History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past year.
  • Poorly controlled type 1 or type 2 diabetes mellitus.
  • Poorly controlled hypertension.
  • Fasting triglycerides > 400 mg/dL
  • 12 lead ECG demonstrating QTcFF >455 msec at screening.
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
 
 
NCT01350141
B1481012
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 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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