A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins
NCT ID: NCT01342211
Last Updated: 2017-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2011-07-31
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
Intravenous placebo monthly during treatment phase.
Statin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Treatment B
PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Statin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Treatment C
PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Statin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Treatment D
PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Satin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Treatment E
PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Statin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Interventions
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Placebo
Intravenous placebo monthly during treatment phase.
Statin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Statin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Statin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Satin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Statin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Eligibility Criteria
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Inclusion Criteria
* 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
* Poorly controlled type 1 or type 2 diabetes mellitus.
* Poorly controlled hypertension.
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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Orange County Research Center
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
In Vivo Clinical Research, Inc.
Doral, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Kendall South Medical Center
Miami, Florida, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
North Georgia Internal Medicine
Woodstock, Georgia, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
Maine Research Associates
Auburn, Maine, United States
Infinity Medical Research
North Dartmouth, Massachusetts, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
Saint Luke's Lipid and Diabetes Research Center
Kansas City, Missouri, United States
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, United States
New Mexico Clinical Research & Osteoporosis Center, Incorporated
Albuquerque, New Mexico, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Oklahoma Cardiovascular Research Group (OCRG)
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
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Translational Research Center
Philadelphia, Pennsylvania, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Paragon Research Center, LLC
San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
San Antonio Preventive & Diagnostic Medicine, PA
San Antonio, Texas, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 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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B1481005
Identifier Type: -
Identifier Source: org_study_id