A 12 Week, Phase 3, Double-blind, Randomized, Placebo-controlled, Parallel Group Study To Assess The Efficacy, Safety, Tolerability And Actual Use Of Bococizumab And An Autoinjector (Pre-filled Pen) In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 299
- Locations
- 30
- Primary Endpoint
- 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
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Treated with a statin - Fasting LDL-C >=70mg/dL and triglycerides <=400mg/dL
Exclusion Criteria
- •Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled hypertension
Arms & Interventions
Bococizumab 150mg
Bococizumab 150mg autoinjector (pre-filled pen)
Intervention: Bococizumab 150mg (Biological)
Bococizumab 75mg
Bococizumab 75mg autoinjector (pre-filled pen)
Intervention: Bococizumab 75mg (Biological)
Bococizumab 150mg placebo
Bococizumab 150mg placebo autoinjector (pre-filled pen)
Intervention: Bococizumab 150mg placebo (Biological)
Bococizumab 75mg placebo
Bococizumab 75mg autoinjector (pre-filled pen)
Intervention: Bococizumab 75mg placebo (Biological)
Outcomes
Primary Outcomes
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
Time Frame: 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 Was the medicine not flowing after needle withdrawn?"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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- 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)
- Plasma Concentration of Bococizumab at Week 12(Week 12)
- Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12(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)
- Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12(Baseline, Week 12)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 18 weeks)