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: October 16, 2013
Last verified: October 2013
  Purpose

This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.


Condition Intervention Phase
Hypercholesterolemia
Dyslipidemia
Biological: Placebo
Biological: PF-04950615 (RN316)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Observed mean percentage reduction from baseline in LDL-C [ Time Frame: Day 85 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 93
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment A Biological: Placebo
Intravenous placebo monthly during treatment phase.
Experimental: Treatment B Biological: PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Other Name: PF-04950615 (RN316)
Experimental: Treatment C Biological: PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Other Name: PF-04950615 (RN316)
Experimental: Treatment D Biological: PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Other Name: PF-04950615 (RN316)
Experimental: Treatment E Biological: PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Other Name: PF-04950615 (RN316)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342211

  Show 38 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01342211     History of Changes
Other Study ID Numbers: B1481005
Study First Received: April 25, 2011
Last Updated: October 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PF-04950615
RN316

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 16, 2014