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

NCT01342211

Last updated date
Study Location
Orange County Research Center
Tustin, California, 92780, United States
Contact
1-800-718-1021

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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

- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High 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 High Doses Of Atorvastatin, Rosuvastatin Or Simvastatin.
Brief Summary This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.
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
  • 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.
Study Arms  ICMJE
  • 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
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: October 16, 2013)
93
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2011)
90
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT01342211
Other Study ID Numbers  ICMJE B1481005
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 September 2017

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