Clinical trial NCT02458287: Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Keywords: mixed dyslipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-06-01
Enrollment: 299
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: 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).


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 12
measure: 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)
timeFrame: Week 0 (Day 1)
measure: 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
timeFrame: Week 2
measure: 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
timeFrame: Week 4
measure: 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
timeFrame: Week 6
measure: 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
timeFrame: Week 8
measure: 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
timeFrame: Week 10
Secondary outcomes:
measure: 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
timeFrame: Week 0 (Day 1), 2, 4, 6, 8, 10
measure: 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
timeFrame: Week 0 (Day 1), 4, 8
measure: 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
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 18 weeks
measure: Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
timeFrame: Baseline up to 18 weeks
measure: Plasma Concentration of Bococizumab at Week 12
timeFrame: Week 12
measure: Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Radiant Research Incorporated
state: Arizona
city: Lincoln
country: United States
facility: Clinical Trial Research
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Northridge
country: United States
facility: California Medical Research Associates Inc.
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Atlantis
country: United States
facility: ACRC - Cardiology
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: Invesclinic, LLC
state: Florida
city: Miami
country: United States
facility: Clinical Research of Miami, Inc.
state: Florida
city: Miami
country: United States
facility: Prestige Clinical Research Center, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: A & R Research Group LLC
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Internal Medicine
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Evanston
country: United States
facility: Evanston Premier Healthcare Research,LLC
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute For Clinical Research
state: Indiana
city: Valparaiso
country: United States
facility: Buynak Clinical Research, P.C.
state: Indiana
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Metairie
country: United States
facility: Omega Clinical Research Center
state: Louisiana
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Mount Pleasant
country: United States
facility: PMG Research Of Charleston
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Hopewell
country: United States
facility: Heart Care Associates, P.C.
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research-Richmond, Inc.
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc.
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.