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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01342211
First received: April 25, 2011
Last updated: April 2, 2013
Last verified: April 2013
History of Changes

April 25, 2011
April 2, 2013
July 2011
February 2012   (final data collection date for primary outcome measure)
Observed mean percentage reduction from baseline in LDL-C [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01342211 on ClinicalTrials.gov Archive Site
  • Proportion of subjects achieving a significant decrease in LDL C from baseline. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Change and percentage change from baseline in other lipid parameters: total cholesterol, HDL C, non-HDL C, TG, ApoB, ApoA1 and Lpa. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Incidence, severity and causal relationship of treatment emergent AEs (TEAEs). [ Time Frame: Day 141 ] [ Designated as safety issue: Yes ]
  • Incidence of abnormal and clinically relevant safety laboratories including clinical chemistry, hematology and coagulation assessments. [ Time Frame: Day 141 ] [ Designated as safety issue: Yes ]
  • Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters. [ Time Frame: Day 141 ] [ Designated as safety issue: Yes ]
  • Incidence of anti-drug-antibodies. [ Time Frame: Day 141 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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 (RN316)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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Dyslipidemia
  • Biological: Placebo
    Intravenous placebo monthly during treatment phase.
  • Biological: PF-04950615 (RN316)
    Intravenous 10mg/mL based on weight monthly during treatment phase.
    Other Name: PF-04950615 (RN316)
  • Placebo Comparator: Treatment A
    Intervention: Biological: Placebo
  • Experimental: Treatment B
    Intervention: Biological: PF-04950615 (RN316)
  • Experimental: Treatment C
    Intervention: Biological: PF-04950615 (RN316)
  • Experimental: Treatment D
    Intervention: Biological: PF-04950615 (RN316)
  • Experimental: Treatment 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
111
July 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01342211
B1481005
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

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