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

NCT ID: NCT02458287

Last Updated: 2017-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-02-29

Brief Summary

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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

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Conditions

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Hyperlipidemia

Keywords

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mixed dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bococizumab 150mg

Bococizumab 150mg autoinjector (pre-filled pen)

Group Type EXPERIMENTAL

Bococizumab 150mg

Intervention Type BIOLOGICAL

Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.

Bococizumab 75mg

Bococizumab 75mg autoinjector (pre-filled pen)

Group Type EXPERIMENTAL

Bococizumab 75mg

Intervention Type BIOLOGICAL

Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.

Bococizumab 150mg placebo

Bococizumab 150mg placebo autoinjector (pre-filled pen)

Group Type PLACEBO_COMPARATOR

Bococizumab 150mg placebo

Intervention Type BIOLOGICAL

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

Bococizumab 75mg placebo

Bococizumab 75mg autoinjector (pre-filled pen)

Group Type PLACEBO_COMPARATOR

Bococizumab 75mg placebo

Intervention Type BIOLOGICAL

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

Interventions

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Bococizumab 150mg

Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.

Intervention Type BIOLOGICAL

Bococizumab 75mg

Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.

Intervention Type BIOLOGICAL

Bococizumab 150mg placebo

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

Intervention Type BIOLOGICAL

Bococizumab 75mg placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Radiant Research Incorporated

Chandler, Arizona, United States

Site Status

Clinical Trial Research

Lincoln, California, United States

Site Status

National Research Institute

Los Angeles, California, United States

Site Status

California Medical Research Associates Inc.

Northridge, California, United States

Site Status

Northern California Research

Sacramento, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

ACRC - Cardiology

Atlantis, Florida, United States

Site Status

Clinical Research of South Florida

Coral Gables, Florida, United States

Site Status

Invesclinic, LLC

Fort Lauderdale, Florida, United States

Site Status

Clinical Research of Miami, Inc.

Miami, Florida, United States

Site Status

Prestige Clinical Research Center, Inc.

Miami, Florida, United States

Site Status

A & R Research Group LLC

Pembroke Pines, Florida, United States

Site Status

Clinical Research Atlanta

Stockbridge, Georgia, United States

Site Status

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status

North Georgia Internal Medicine

Woodstock, Georgia, United States

Site Status

Solaris Clinical Research

Meridian, Idaho, United States

Site Status

Evanston Premier Healthcare Research,LLC

Evanston, Illinois, United States

Site Status

Midwest Institute For Clinical Research

Indianapolis, Indiana, United States

Site Status

Buynak Clinical Research, P.C.

Valparaiso, Indiana, United States

Site Status

L-MARC Research Center

Louisville, Kentucky, United States

Site Status

Omega Clinical Research Center

Metairie, Louisiana, United States

Site Status

PharmQuest

Greensboro, North Carolina, United States

Site Status

Sterling Research Group, Ltd.

Cincinnati, Ohio, United States

Site Status

PMG Research Of Charleston

Mt. Pleasant, South Carolina, United States

Site Status

Palmetto Clinical Research

Summerville, South Carolina, United States

Site Status

Texas Center for Drug Development, Inc.

Houston, Texas, United States

Site Status

Heart Care Associates, P.C.

Hopewell, Virginia, United States

Site Status

Manassas Clinical Research Center

Manassas, Virginia, United States

Site Status

National Clinical Research-Richmond, Inc.

Richmond, Virginia, United States

Site Status

Rainier Clinical Research Center, Inc.

Renton, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28304227 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1481046&StudyName=A%2012%20Week%2C%20Phase%203%2C%20Double-blind%2C%20Randomized%2C%20Placebo-controlled%2C%20Parallel%20Group%20Study%20To%20Assess%20The%20Efficacy%2C%20Safety%2C%20Tolerability%20And%20Actual%20Use%20Of%20Bococizumab%20And%20An%20Autoinjector%20%28pre-filled%20Pen%29%20In%20Subjects%20With%20Primary%20Hyperlipidemia%20Or%20Mixed%20Dyslipidemia

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Other Identifiers

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SPIRE-AI

Identifier Type: OTHER

Identifier Source: secondary_id

B1481046

Identifier Type: -

Identifier Source: org_study_id