Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia
- Conditions
- Hyperlipidemia
- Interventions
- Biological: Bococizumab 150mgBiological: Bococizumab 75mgBiological: Bococizumab 150mg placeboBiological: Bococizumab 75mg placebo
- Registration Number
- NCT02458287
- Lead Sponsor
- Pfizer
- Brief Summary
This study is a multicenter, randomized study in subjects with high cholesterol receiving statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of bococizumab and an autoinjector (pre-filled pen).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 299
- Treated with a statin - Fasting LDL-C >=70mg/dL and triglycerides <=400mg/dL
- Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bococizumab 150mg Bococizumab 150mg Bococizumab 150mg autoinjector (pre-filled pen) Bococizumab 75mg Bococizumab 75mg Bococizumab 75mg autoinjector (pre-filled pen) Bococizumab 150mg placebo Bococizumab 150mg placebo Bococizumab 150mg placebo autoinjector (pre-filled pen) Bococizumab 75mg placebo Bococizumab 75mg placebo Bococizumab 75mg autoinjector (pre-filled pen)
- Primary Outcome Measures
Name Time Method Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4 Week 4 A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2 Week 2 A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8 Week 8 A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo Baseline, Week 12 Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1) Week 0 (Day 1) A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10 Week 10 A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6 Week 6 A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 Baseline, Week 12 Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10 Week 0 (Day 1), 2, 4, 6, 8, 10 A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 Baseline, Week 12 Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 75 mg Dose Group and Matched Placebo Baseline, Week 12 Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) Baseline up to 18 weeks Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer levels \>=6.23 were considered as ADA positive and participants with their nAb titer level \>=1.58 were considered as nAb positive.
Plasma Concentration of Bococizumab at Week 12 Week 12 Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12 Week 12 PCSK9 is an enzyme encoded by the PCSK9 gene in humans on chromosome. It is the 9th member of the proprotein convertase family of proteins that activate other proteins.
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 Baseline, Week 12 Percentage of Injections That Met the Definition for Successful Assessment Using the Observer Assessment Tool (OAT) for Bococizumab 150 mg Dose, Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 4 and 8 Week 0 (Day 1), 4, 8 As per the OAT, a 'successful' injection was based on observer's response for the question - "Was the administration successful?''. Observer's response being 'Yes' corresponded to a successful injection.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to 18 weeks An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the follow up visit (up to 18 weeks), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Trial Locations
- Locations (30)
Omega Clinical Research Center
🇺🇸Metairie, Louisiana, United States
National Research Institute
🇺🇸Los Angeles, California, United States
A & R Research Group LLC
🇺🇸Pembroke Pines, Florida, United States
Evanston Premier Healthcare Research,LLC
🇺🇸Evanston, Illinois, United States
North Georgia Internal Medicine
🇺🇸Woodstock, Georgia, United States
PMG Research Of Charleston
🇺🇸Mount Pleasant, South Carolina, United States
Rainier Clinical Research Center, Inc.
🇺🇸Renton, Washington, United States
Heart Care Associates, P.C.
🇺🇸Hopewell, Virginia, United States
ACRC - Cardiology
🇺🇸Atlantis, Florida, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Palmetto Clinical Research
🇺🇸Summerville, South Carolina, United States
Invesclinic, LLC
🇺🇸Fort Lauderdale, Florida, United States
California Medical Research Associates Inc.
🇺🇸Northridge, California, United States
Clinical Trial Research
🇺🇸Lincoln, California, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Radiant Research Incorporated
🇺🇸Chandler, Arizona, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Buynak Clinical Research, P.C.
🇺🇸Valparaiso, Indiana, United States
Northern California Research
🇺🇸Sacramento, California, United States
Clinical Research of Miami, Inc.
🇺🇸Miami, Florida, United States
Prestige Clinical Research Center, Inc.
🇺🇸Miami, Florida, United States
Midwest Institute For Clinical Research
🇺🇸Indianapolis, Indiana, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Sterling Research Group, Ltd.
🇺🇸Cincinnati, Ohio, United States
National Clinical Research-Richmond, Inc.
🇺🇸Richmond, Virginia, United States