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

Hyperlipidemia Clinical Trial

— SPIRE-AI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458287
• Other study ID #: B1481046
• Secondary ID: SPIRE-AI
• Status: Completed
• Phase: Phase 3
• First received: April 2, 2015
• Last updated: November 20, 2017
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Biological:
• Bococizumab 150mg
Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.
• Bococizumab 75mg
Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.
• Bococizumab 150mg placebo
Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
• Bococizumab 75mg placebo
Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.

Locations

Country	Name	City	State
United States	ACRC - Cardiology	Atlantis	Florida
United States	Radiant Research Incorporated	Chandler	Arizona
United States	Sterling Research Group, Ltd.	Cincinnati	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Evanston Premier Healthcare Research,LLC	Evanston	Illinois
United States	Invesclinic, LLC	Fort Lauderdale	Florida
United States	PharmQuest	Greensboro	North Carolina
United States	Heart Care Associates, P.C.	Hopewell	Virginia
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Midwest Institute For Clinical Research	Indianapolis	Indiana
United States	Clinical Trial Research	Lincoln	California
United States	National Research Institute	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Solaris Clinical Research	Meridian	Idaho
United States	Omega Clinical Research Center	Metairie	Louisiana
United States	Clinical Research of Miami, Inc.	Miami	Florida
United States	Prestige Clinical Research Center, Inc.	Miami	Florida
United States	PMG Research Of Charleston	Mount Pleasant	South Carolina
United States	California Medical Research Associates Inc.	Northridge	California
United States	A & R Research Group LLC	Pembroke Pines	Florida
United States	Rainier Clinical Research Center, Inc.	Renton	Washington
United States	National Clinical Research-Richmond, Inc.	Richmond	Virginia
United States	Northern California Research	Sacramento	California
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Buynak Clinical Research, P.C.	Valparaiso	Indiana
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	North Georgia Clinical Research	Woodstock	Georgia
United States	North Georgia Internal Medicine	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	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), 2, 4, 6, 8, 10
Secondary	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	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.	Week 0 (Day 1), 4, 8
Secondary	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
Secondary	Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12		Baseline, Week 12
Secondary	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12		Baseline, Week 12
Secondary	Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12		Baseline, Week 12
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	Baseline up to 18 weeks
Secondary	Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)	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.	Baseline up to 18 weeks
Secondary	Plasma Concentration of Bococizumab at Week 12		Week 12
Secondary	Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at 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.	Week 12

External Links

•   To obtain contact information for a study center near you, click here.