Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia
SPIRE-AI
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
2 other identifiers
interventional
299
1 country
30
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2015
Shorter than P25 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
December 19, 2017
CompletedDecember 19, 2017
November 1, 2017
8 months
April 2, 2015
October 9, 2017
November 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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)
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 Was the medicine not flowing after needle withdrawn?"
Week 0 (Day 1)
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
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?"
Week 2
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
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?"
Week 4
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
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?"
Week 6
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
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?"
Week 8
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
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?"
Week 10
Secondary Outcomes (10)
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
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 at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 75 mg Dose Group and Matched Placebo
Baseline, Week 12
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Baseline, Week 12
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Baseline, Week 12
- +5 more secondary outcomes
Study Arms (4)
Bococizumab 150mg
EXPERIMENTALBococizumab 150mg autoinjector (pre-filled pen)
Bococizumab 75mg
EXPERIMENTALBococizumab 75mg autoinjector (pre-filled pen)
Bococizumab 150mg placebo
PLACEBO COMPARATORBococizumab 150mg placebo autoinjector (pre-filled pen)
Bococizumab 75mg placebo
PLACEBO COMPARATORBococizumab 75mg autoinjector (pre-filled pen)
Interventions
Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.
Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.
Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
Eligibility Criteria
You may qualify if:
- Treated with a statin - Fasting LDL-C \>=70mg/dL and triglycerides \<=400mg/dL
You may not qualify if:
- Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (30)
Radiant Research Incorporated
Chandler, Arizona, 85224, United States
Clinical Trial Research
Lincoln, California, 95648, United States
National Research Institute
Los Angeles, California, 90057, United States
California Medical Research Associates Inc.
Northridge, California, 91324, United States
Northern California Research
Sacramento, California, 95821, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
ACRC - Cardiology
Atlantis, Florida, 33462, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Invesclinic, LLC
Fort Lauderdale, Florida, 33308, United States
Clinical Research of Miami, Inc.
Miami, Florida, 33126, United States
Prestige Clinical Research Center, Inc.
Miami, Florida, 33133, United States
A & R Research Group LLC
Pembroke Pines, Florida, 33024, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
North Georgia Internal Medicine
Woodstock, Georgia, 30189, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Evanston Premier Healthcare Research,LLC
Evanston, Illinois, 60201, United States
Midwest Institute For Clinical Research
Indianapolis, Indiana, 46260, United States
Buynak Clinical Research, P.C.
Valparaiso, Indiana, 46383, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Omega Clinical Research Center
Metairie, Louisiana, 70006, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45219, United States
PMG Research Of Charleston
Mt. Pleasant, South Carolina, 29464, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
Heart Care Associates, P.C.
Hopewell, Virginia, 23860, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
National Clinical Research-Richmond, Inc.
Richmond, Virginia, 23294, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057, United States
Related Publications (1)
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.
PMID: 28304227DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2015
First Posted
June 1, 2015
Study Start
June 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
December 19, 2017
Results First Posted
December 19, 2017
Record last verified: 2017-11