Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
NCT ID: NCT01592240
Last Updated: 2017-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
354 participants
INTERVENTIONAL
2012-07-31
2013-05-31
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
TRIPLE
Study Groups
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Q28d Dosing Arm
A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month.
PBO
Placebo Q28d
200mg PF-04950615 (RN316)
PF-04950615 200 mg, Q28d
300mg PF-04950615 (RN316)
PF-04950615 300 mg, Q28d
Q14d Dosing Arm
A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q14d dose group will receive subcutaneous administration of PF-04950615 or Placebo every 2 weeks.
PBO
Placebo, Q14d
PF-04950615
PF-04950615 50mg, Q14d
PF-04950615
PF-04950615 100 mg, Q14d
PF-04950615
PF-04950615 150mg, Q14d
Interventions
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PBO
Placebo Q28d
200mg PF-04950615 (RN316)
PF-04950615 200 mg, Q28d
300mg PF-04950615 (RN316)
PF-04950615 300 mg, Q28d
PBO
Placebo, Q14d
PF-04950615
PF-04950615 50mg, Q14d
PF-04950615
PF-04950615 100 mg, Q14d
PF-04950615
PF-04950615 150mg, Q14d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on Day 1:
* Fasting LDL-C greater than or equal to 80 mg/dL (2.31 mmol/L);
* Fasting TG less than or equal to 400 mg/dL (4.52 mmol/L).
* Subject's fasting LDL-cholesterol must greater than or equal to 80 mg/dL (2.31 mmol/L at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial.
Exclusion Criteria
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
* Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 63 days after last dose of investigational product.
* History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past 6 months. Congestive heart failure (CHF), NYHA functional classes III or IV.
* Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c \>9%).
* 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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Protenium Clinical Research, LLC
Hurst, Texas, United States
Paragon Research Center, LLC
San Antonio, Texas, United States
Innovative Clinical Trials
San Antonio, Texas, United States
National Clinical Research- Norfolk, Inc
Norfolk, Virginia, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
The Office of James G. McMurray, MD
Huntsville, Alabama, United States
Southwest Heart Group
Tucson, Arizona, United States
Aureus Research Inc.
Little Rock, Arkansas, United States
Universal Biopharma Research Institute Inc. - Alta Family Health Clinic
Dinuba, California, United States
Clinical Trials Research
Lincoln, California, United States
The Office of Lucita M. Cruz, MD, Inc.
Norwalk, California, United States
Radiant Research
Santa Rosa, California, United States
St. Joseph's Medical Associates
Stockton, California, United States
Orange County Research Center
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Zasa Clinical Research
Boynton Beach, Florida, United States
Florida Health Center
Davie, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Florida Research Network, LLC
Gainesville, Florida, United States
In Vivo Clinical Research, Inc.
Hialeah, Florida, United States
Health Care Family Rehab and Research Center
Hialeah, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Community Research Foundation, Inc.
Miami, Florida, United States
Kendall South Medical Center, Inc.
Miami, Florida, United States
Omega Research Consultants, LLC
Orlando, Florida, United States
DMI Research
Pinellas Park, Florida, United States
St Johns Center for Clinical Research
Ponte Vedra, Florida, United States
The Office of Bridget Bellingar, DO
Seminole, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Radiant Research, Inc.
Atlanta, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Northwest Clinical Trials
Boise, Idaho, United States
Fox Valley Clinical Research Center, LLC
Aurora, Illinois, United States
Radiant Research, Inc.
Chicago, Illinois, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
Midwest Heart & Vascular Specialists
Overland Park, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Crescent City Clinical Research Center
Metairie, Louisiana, United States
Maine Research Associates
Auburn, Maine, United States
Maine Research Associates
Lewiston, Maine, United States
ActivMed Practices and Research
Haverhill, Massachusetts, United States
Radiant Research, Inc.
Edina, Minnesota, United States
Dybedal Clinical Research Center
Kansas City, Missouri, United States
Montana Medical Research, Inc.
Missoula, Montana, United States
Meridian Clinical Research
Omaha, Nebraska, United States
New Mexico Clinical Research and Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States
Central New York Clinical Research
Manlius, New York, United States
Clinical Trials of America, Inc.
Hickory, North Carolina, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
PMG Research of Raleigh
Raleigh, North Carolina, United States
Wake Internal Medicine Consultants
Raleigh, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Ardmore Family Practice
Winston-Salem, North Carolina, United States
Clinical Trials of America, Inc.
Winston-Salem, North Carolina, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
Sentral Clinical Research Services
Cincinnati, Ohio, United States
Sterling Research Group, LTD.
Cincinnati, Ohio, United States
Albert J. Weisbrot, M.D., Inc.
Mason, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Baylor College of Medicine - Center for Cardiovascular Disease Prevention
Houston, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
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.
Ballantyne CM, Neutel J, Cropp A, Duggan W, Wang EQ, Plowchalk D, Sweeney K, Kaila N, Vincent J, Bays H. Results of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, from a randomized, placebo-controlled, dose-ranging study in statin-treated subjects with hypercholesterolemia. Am J Cardiol. 2015 May 1;115(9):1212-21. doi: 10.1016/j.amjcard.2015.02.006. Epub 2015 Feb 12.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2012-001226-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1481015
Identifier Type: -
Identifier Source: org_study_id