A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
NCT ID: NCT01350141
Last Updated: 2017-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2011-06-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment A
Placebo
An infusion lasting approximately 60 minutes
Treatment B
PF-04950615 (RN316)
An infusion lasting approximately 60 minutes
Treatment C
PF-04950615 (RN316)
An infusion lasting approximately 60 minutes
Interventions
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Placebo
An infusion lasting approximately 60 minutes
PF-04950615 (RN316)
An infusion lasting approximately 60 minutes
PF-04950615 (RN316)
An infusion lasting approximately 60 minutes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Advance Outcome Management, Inc.
Garden Grove, California, United States
Collaborative Neuroscience Network, Inc
Garden Grove, California, United States
Collaborative Neuroscience Network, Inc.
Long Beach, California, United States
Elite Clinical Trials, Inc.
Wildomar, California, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Kendall South Medical Center, Inc.
Miami, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Midwest Cardiology Associates
Overland Park, Kansas, United States
Stark Pharmacy
Overland Park, Kansas, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
Saint Luke's Lipid and Diabetes Research Center
Kansas City, Missouri, United States
Advance Clinical Research
St Louis, Missouri, United States
Wake Internal Medicine Consultants, Inc.
Raleigh, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital Physicians
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Texas Center for Drug Development, Inc
Houston, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
Aspen Clinical Research, LLC
Orem, Utah, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States
The Medical Arts Health Research Group
Kelowna, British Columbia, Canada
Q & T Research Chicoutimi
Chicoutimi, Quebec, Canada
Centre de Recherche Clinique de Laval
Laval, Quebec, Canada
Diex Research Montreal Inc.
Montreal, Quebec, Canada
Clinique des Maladies Lipidiques de Quebec Inc.
Québec, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Countries
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References
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Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
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.
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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1481012
Identifier Type: -
Identifier Source: org_study_id