Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia

Phase 3

Completed

• Conditions: Hyperlipidemia

• 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

Study Timeline

• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-05-27
• Study Start: 2015-06
• Study First Posted: 2015-06-01
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Disposition First Submitted: 2017-03-07
• Disposition First Submitted QC: 2017-03-07
• Disposition First Posted: 2017-03-08
• Results First Submitted: 2017-10-09
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-20
• Last Update Submitted: 2017-11-20
• Results First Posted: 2017-12-19
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 Was the medicine not flowing after needle withdrawn?"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 Was the medicine not flowing after needle withdrawn?"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.
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.
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	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)

Radiant Research Incorporated; 🇺🇸 Chandler, Arizona, United States

Clinical Trial Research; 🇺🇸 Lincoln, California, United States

National Research Institute; 🇺🇸 Los Angeles, California, United States

California Medical Research Associates Inc.; 🇺🇸 Northridge, California, United States

Northern California Research; 🇺🇸 Sacramento, California, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

ACRC - Cardiology; 🇺🇸 Atlantis, Florida, United States

Clinical Research of South Florida; 🇺🇸 Coral Gables, Florida, United States

Invesclinic, LLC; 🇺🇸 Fort Lauderdale, Florida, United States

Clinical Research of Miami, Inc.; 🇺🇸 Miami, Florida, United States

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