Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT01592240
- Lead Sponsor
- Pfizer
- Brief Summary
To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is \>/=80 mg/dL on background treatment with a statin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 354
- Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial.
- 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.
- Participation in other studies within 3 months before the current study begins and/or during study participation.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Q28d Dosing Arm 200mg PF-04950615 (RN316) 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. Q28d Dosing Arm 300mg PF-04950615 (RN316) 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. Q28d Dosing Arm PBO 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. Q14d Dosing Arm PBO 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. Q14d Dosing Arm PF-04950615 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24 Baseline, Week 12, 24 Change From Baseline in Total Cholesterol at Week 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Total Cholesterol at Week 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24 Baseline, Week 12, 24 Plasma Concentration of PF-04950615 at Week 12 and 24 Week 12, 24 Percentage of Participants With Injection Site Adverse Events Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups Injection site adverse events included injection site bruising, discomfort, erythema, hemorrhage, induration, inflammation, pain, paresthesia, pruritus, swelling, urticaria, reaction and rash.
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24 Baseline, Week 12, 24 Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Triglycerides at Week 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24 Baseline, Week 12, 24 Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA) Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups Participants with titer value greater than or equal to 4.32 nanogram per milliliter were considered positive.
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 Baseline, Week 24 Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24 Baseline, Week 12, 24 Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24 Baseline, Week 12, 24 Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24 Baseline, Week 12, 24 Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24 Baseline, Week 12, 24 Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24 Baseline, Week 12, 24 Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24 Baseline, Week 12, 24 Change From Baseline in Triglycerides at Week 12 and 24 Baseline, Week 12, 24 Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL) Week 12, 24
Trial Locations
- Locations (70)
Southwest Heart Group
🇺🇸Tucson, Arizona, United States
Universal Biopharma Research Institute Inc. - Alta Family Health Clinic
🇺🇸Dinuba, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
In Vivo Clinical Research, Inc.
🇺🇸Hialeah, Florida, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Health Care Family Rehab and Research Center
🇺🇸Hialeah, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Radiant Research
🇺🇸Santa Rosa, California, United States
St. Joseph's Medical Associates
🇺🇸Stockton, California, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Crescent City Clinical Research Center
🇺🇸Metairie, Louisiana, United States
The Office of James G. McMurray, MD
🇺🇸Huntsville, Alabama, United States
Fox Valley Clinical Research Center, LLC
🇺🇸Aurora, Illinois, United States
Medical Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
The Office of Lucita M. Cruz, MD, Inc.
🇺🇸Norwalk, California, United States
Zasa Clinical Research
🇺🇸Boynton Beach, Florida, United States
Maine Research Associates
🇺🇸Lewiston, Maine, United States
St Johns Center for Clinical Research
🇺🇸Ponte Vedra, Florida, United States
Wake Internal Medicine Consultants
🇺🇸Raleigh, North Carolina, United States
Kendall South Medical Center, Inc.
🇺🇸Miami, Florida, United States
Baylor College of Medicine - Center for Cardiovascular Disease Prevention
🇺🇸Houston, Texas, United States
Midwest Heart & Vascular Specialists
🇺🇸Overland Park, Kansas, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Innovative Clinical Trials
🇺🇸San Antonio, Texas, United States
Aureus Research Inc.
🇺🇸Little Rock, Arkansas, United States
Florida Health Center
🇺🇸Davie, Florida, United States
Community Research Foundation, Inc.
🇺🇸Miami, Florida, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
ActivMed Practices and Research
🇺🇸Haverhill, Massachusetts, United States
Montana Medical Research, Inc.
🇺🇸Missoula, Montana, United States
Central New York Clinical Research
🇺🇸Manlius, New York, United States
PMG Research of Raleigh
🇺🇸Raleigh, North Carolina, United States
PMG Research of Salisbury
🇺🇸Salisbury, 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
🇺🇸Mount Pleasant, 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
Protenium Clinical Research, LLC
🇺🇸Hurst, Texas, United States
National Clinical Research- Norfolk, Inc
🇺🇸Norfolk, Virginia, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
Palmetto Clinical Research
🇺🇸Summerville, South Carolina, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Radiant Research, Inc.
🇺🇸Edina, Minnesota, United States
The Office of Bridget Bellingar, DO
🇺🇸Seminole, Florida, United States
DMI Research
🇺🇸Pinellas Park, Florida, United States
Florida Research Network, LLC
🇺🇸Gainesville, Florida, United States
Omega Research Consultants, LLC
🇺🇸Orlando, Florida, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Dybedal Clinical Research Center
🇺🇸Kansas City, Missouri, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
New Mexico Clinical Research and Osteoporosis Center, Inc.
🇺🇸Albuquerque, New Mexico, United States
Clinical Trials of America, Inc.
🇺🇸Winston-Salem, North Carolina, United States
Ardmore Family Practice
🇺🇸Winston-Salem, North Carolina, United States
National Clinical Research - Richmond, Inc.
🇺🇸Richmond, Virginia, United States