Clinical trial NCT01342211: A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High 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 High Doses Of Atorvastatin, Rosuvastatin Or Simvastatin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Dyslipidemia
Keywords: PF-04950615
RN316
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-04-27
Enrollment: 93
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: This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.


Eligibility 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.

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 <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 Relevant Laboratory Abnormalities
timeFrame: Day 1 up to Day 141
measure: Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
timeFrame: Day 1 up to Day 141
measure: Number of Participants With Anti-drug Antibody (ADA)
timeFrame: Day 1 up to Day 141
Other outcomes:
measure: Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
timeFrame: Baseline, Day 29, 57, 71, 85, 99, 127, 141
measure: Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
timeFrame: Baseline, Day 29, 57, 71, 85, 99, 127, 141
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, 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: Doral
country: United States
facility: In Vivo Clinical Research, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center
state: Florida
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Internal Medicine
state: Georgia
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: North Dartmouth
country: United States
facility: Infinity Medical Research
state: Massachusetts
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: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, P.C.
state: Missouri
city: Saint Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center, Incorporated
state: New Mexico
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
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 (OCRG)
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: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Translational Research Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: San Antonio
country: United States
facility: Paragon Research Center, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: San Antonio Preventive & Diagnostic Medicine, PA
state: Texas
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc.
state: Virginia
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.