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Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

NCT ID: NCT01375777

Last Updated: 2022-11-08

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

PHASE2

Total Enrollment

411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-06

Study Completion Date

2012-03-02

Brief Summary

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The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.

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Detailed Description

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Conditions

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Hyperlipidemia

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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Placebo Q2W

Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo to Evolocumab

Intervention Type OTHER

Administered by subcutaneous injection

Placebo Q4W

Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo to Evolocumab

Intervention Type OTHER

Administered by subcutaneous injection

Ezetimibe

Participants received 10 mg ezetimibe orally once a day for 12 weeks.

Group Type ACTIVE_COMPARATOR

Ezetimibe

Intervention Type DRUG

Administered orally once a day

Evolocumab 70 mg Q2W

Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Evolocumab 105 mg Q2W

Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Evolocumab 140 mg Q2W

Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Evolocumab 280 mg Q4W

Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Evolocumab 350 mg Q4W

Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Evolocumab 420 mg Q4W

Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Interventions

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Evolocumab

Administered by subcutaneous injection

Intervention Type BIOLOGICAL

Ezetimibe

Administered orally once a day

Intervention Type DRUG

Placebo to Evolocumab

Administered by subcutaneous injection

Intervention Type OTHER

Other Intervention Names

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AMG 145 Repatha Zetia

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥ 18 to ≤ 75 years of age
* Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and \< 190 mg/dL
* Framingham risk score of 10% or less
* Fasting triglycerides \< 400 mg/dL

Exclusion Criteria

* History of coronary heart disease
* New York Heart Association (NYHA) II - IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Birmingham, Alabama, United States

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Little Rock, Arkansas, United States

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Encinitas, California, United States

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Inglewood, California, United States

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San Diego, California, United States

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Tustin, California, United States

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DeLand, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Ponte Vedra, Florida, United States

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Sanford, Florida, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Bethesda, Maryland, United States

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Brockton, Massachusetts, United States

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Brooklyn Center, Minnesota, United States

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Las Vegas, Nevada, United States

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Endwell, New York, United States

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New Windsor, New York, United States

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Raleigh, North Carolina, United States

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Raleigh, North Carolina, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Mt. Pleasant, South Carolina, United States

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Rapid City, South Dakota, United States

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Arlington, Texas, United States

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Boerne, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Renton, Washington, United States

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Seattle, Washington, United States

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Maroubra, New South Wales, Australia

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Carina Heights, Queensland, Australia

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Anthée, , Belgium

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Dour, , Belgium

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Gozée, , Belgium

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Gribomont, , Belgium

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Halen, , Belgium

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Ham, , Belgium

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Linkebeek, , Belgium

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Retie, , Belgium

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Bay Roberts, Newfoundland and Labrador, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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Toronto, Ontario, Canada

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Granby, Quebec, Canada

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Aalborg, , Denmark

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Ballerup Municipality, , Denmark

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Vejle, , Denmark

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Countries

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United States Australia Belgium Canada Denmark

References

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Koren MJ, Scott R, Kim JB, Knusel B, Liu T, Lei L, Bolognese M, Wasserman SM. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2012 Dec 8;380(9858):1995-2006. doi: 10.1016/S0140-6736(12)61771-1. Epub 2012 Nov 6.

Reference Type BACKGROUND
PMID: 23141812 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20101154

Identifier Type: -

Identifier Source: org_study_id

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