Clinical trial NCT01592240: Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
Official title: A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose-ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Monthly And Twice Monthly Subcutaneous Dosing For Six Months In Hypercholesterolemic Subjects On A Statin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: PF-04950615
RN316
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 354
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
timeFrame: Baseline, Week 24
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Total Cholesterol at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Total Cholesterol at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Triglycerides at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Triglycerides at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)
timeFrame: Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups
measure: Percentage of Participants With Injection Site Adverse Events
timeFrame: Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups
measure: Plasma Concentration of PF-04950615 at Week 12 and 24
timeFrame: Week 12, 24
measure: Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)
timeFrame: Week 12, 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Huntsville
country: United States
facility: The Office of James G. McMurray, MD
state: Alabama
city: Tucson
country: United States
facility: Southwest Heart Group
state: Arizona
city: Little Rock
country: United States
facility: Aureus Research Inc.
state: Arkansas
city: Dinuba
country: United States
facility: Universal Biopharma Research Institute Inc. - Alta Family Health Clinic
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Norwalk
country: United States
facility: The Office of Lucita M. Cruz, MD, Inc.
state: California
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Associates
state: California
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: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Boynton Beach
country: United States
facility: Zasa Clinical Research
state: Florida
city: Davie
country: United States
facility: Florida Health Center
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Gainesville
country: United States
facility: Florida Research Network, LLC
state: Florida
city: Hialeah
country: United States
facility: In Vivo Clinical Research, Inc.
state: Florida
city: Hialeah
country: United States
facility: Health Care Family Rehab and Research Center
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Community Research Foundation, Inc.
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center, Inc.
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants, LLC
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research
state: Florida
city: Ponte Vedra
country: United States
facility: St Johns Center for Clinical Research
state: Florida
city: Seminole
country: United States
facility: The Office of Bridget Bellingar, DO
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Radiant Research, Inc.
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Aurora
country: United States
facility: Fox Valley Clinical Research Center, LLC
state: Illinois
city: Chicago
country: United States
facility: Radiant Research, Inc.
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Overland Park
country: United States
facility: Midwest Heart & Vascular Specialists
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Metairie
country: United States
facility: Crescent City Clinical Research Center
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Lewiston
country: United States
facility: Maine Research Associates
state: Maine
city: Haverhill
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Edina
country: United States
facility: Radiant Research, Inc.
state: Minnesota
city: Kansas City
country: United States
facility: Dybedal Clinical Research Center
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc.
state: Montana
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Albuquerque
country: United States
facility: New Mexico Clinical Research and Osteoporosis Center, Inc.
state: New Mexico
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: Hickory
country: United States
facility: Clinical Trials of America, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Raleigh
country: United States
facility: Wake Internal Medicine Consultants
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Winston-Salem
country: United States
facility: Ardmore Family Practice
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trials of America, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, LTD.
state: Ohio
city: Mason
country: United States
facility: Albert J. Weisbrot, M.D., Inc.
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Greenville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical 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: Baylor College of Medicine - Center for Cardiovascular Disease Prevention
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Paragon Research Center, LLC
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
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: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.