Clinical trial NCT01350141: A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
Official title: A Phase 2, Double-blind, Placebo-controlled, Randomized Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Multiple Intravenous Doses In Hypercholesterolemic Subjects On Maximum Dose Of Atorvastatin Or Rosuvastatin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Dyslipidemia
Keywords: Hypercholesterolemia
dyslipidemia
high cholesterol
LDL
antibody
PCSK9
PF-04950615
RN316
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85
timeFrame: Baseline, Day 85
Secondary outcomes:
measure: Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL)
timeFrame: Day 29, 57, 85
measure: Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Day 29, 57, 85
measure: Change From Baseline in Lipid Parameters at Day 29, 57 and 85
timeFrame: Baseline, Day 29, 57, 85
measure: Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
timeFrame: Baseline, Day 29, 57, 85
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to Day 141
measure: Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
timeFrame: Day 1 up to Day 141
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Screening up to Day 141
measure: Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
timeFrame: Screening up to Day 141
measure: Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)
timeFrame: Day 1 up to Day 141
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Garden Grove
country: United States
facility: Advance Outcome Management, Inc.
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Inc.
state: California
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Overland Park
country: United States
facility: Midwest Cardiology Associates
state: Kansas
city: Overland Park
country: United States
facility: Stark Pharmacy
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Lipid and Diabetes Research Center
state: Missouri
city: Saint Louis
country: United States
facility: Advance Clinical Research
state: Missouri
city: Raleigh
country: United States
facility: Wake Internal Medicine Consultants, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Physicians
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Greer
country: United States
facility: DeGarmo Institute of Medical Research
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research, LLC
state: Utah
city: Richmond
country: United States
facility: National Clinical Research - Richmond, Inc.
state: Virginia
city: Kelowna
country: Canada
facility: The Medical Arts Health Research Group
state: British Columbia
city: Chicoutimi
country: Canada
facility: Q & T Research Chicoutimi
state: Quebec
city: Laval
country: Canada
facility: Centre de Recherche Clinique de Laval
state: Quebec
city: Montreal
country: Canada
facility: Diex Research Montreal Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: Clinique des Maladies Lipidiques de Quebec Inc.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Wan H, Gumbiner B, Joh T, Riel T, Udata C, Forgues P, Garzone PD. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition with Bococizumab on Lipoprotein Particles in Hypercholesterolemic Subjects. Clin Ther. 2017 Nov;39(11):2243-2259.e5. doi: 10.1016/j.clinthera.2017.09.009. Epub 2017 Oct 14.
citation: Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.