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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01350141
First received: May 3, 2011
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.


Condition Intervention Phase
Hypercholesterolemia
Dyslipidemia
Other: Placebo
Drug: 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 Maximum Dose Of Atorvastatin Or Rosuvastatin

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage change from baseline in LDL C. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving a decrease in LDL C from baseline. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Changes and percentage changes from baseline in other lipid parameters: total cholesterol, HDL C, non HDL C, TG, ApoB, and ApoA1. [ 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, ECG parameters and anti drug antibodies. [ Time Frame: Day 141 ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment A Other: Placebo
An infusion lasting approximately 60 minutes
Experimental: Treatment B Drug: PF-04950615 (RN316)
An infusion lasting approximately 60 minutes
Other Name: PF-04950615 (RN316)
Experimental: Treatment C Drug: PF-04950615 (RN316)
An infusion lasting approximately 60 minutes
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:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350141

  Show 29 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: NCT01350141     History of Changes
Other Study ID Numbers: B1481012
Study First Received: May 3, 2011
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Hypercholesterolemia
dyslipidemia
high cholesterol
LDL
antibody
PCSK9
PF-04950615
RN316

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

ClinicalTrials.gov processed this record on April 17, 2014