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

NCT01350141

Last updated date
Study Location
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[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 + 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 < 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 (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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
Official Title  ICMJE 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.
Brief Summary PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia
  • Dyslipidemia
Intervention  ICMJE
  • Other: Placebo
    An infusion lasting approximately 60 minutes
  • Drug: PF-04950615 (RN316)
    An infusion lasting approximately 60 minutes
Study Arms  ICMJE
  • Placebo Comparator: Treatment A
    Intervention: Other: Placebo
  • Experimental: Treatment B
    Intervention: Drug: PF-04950615 (RN316)
  • Experimental: Treatment C
    Intervention: Drug: PF-04950615 (RN316)
Publications *

*   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: July 30, 2012)
46
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2011)
54
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01350141
Other Study ID Numbers  ICMJE B1481012
Has Data Monitoring Committee Yes
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 October 2017

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