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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Dyslipidemias
Hypercholesterolemia
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 19, 2014