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

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:

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

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

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

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:	July 30, 2012
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 May 19, 2013