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Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4

NCT ID: NCT02634580

Last Updated: 2020-11-10

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

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-27

Study Completion Date

2018-05-26

Brief Summary

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The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin.

Detailed Description

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After screening participants who met all inclusion/exclusion criteria were randomized with an allocation ratio of 2:2:1:1 into 4 groups: evolocumab (AMG 145) 420 mg administered by subcutaneous injection monthly and placebo pill daily; evolocumab 140 mg administered by subcutaneous injection every two weeks and placebo pill by mouth daily; placebo 420 mg administered by subcutaneous injection monthly and ezetimibe 10 mg pill daily; placebo 140 mg administered subcutaneous injection every two weeks and ezetimibe 10 mg pill daily. Randomization was stratified by screening LDL-C level and baseline statin use. Participants on low or atypical statin dose therapy must have been on a stable dose for at least 4 weeks prior to screening and throughout the blinded portion of the study; the dose could not be adjusted during screening and for the duration of the study. After Week 12, ezetimibe was discontinued and participants moved to an open-label dose of evolocumab administered by subcutaneous injection either every two weeks or monthly and their standard of care.

Conditions

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Hypercholesterolemia

Keywords

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Japanese High cholesterol Treatment of high cholesterol Lowering cholesterol Lowering high cholesterol Hypercholesterolemia Statin intolerant

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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Ezetimibe (Q2W)

Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for 12 weeks. From week 12 participants received open-label evolocumab 140 mg subcutaneously once every 2 weeks until week 48.

Group Type ACTIVE_COMPARATOR

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Ezetimibe

Intervention Type DRUG

Tablet for oral administration

Placebo to Evolocumab

Intervention Type DRUG

Administered by subcutaneous injection

Ezetimibe (QM)

Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for 12 weeks. From week 12 participants received open-label evolocumab 420 mg subcutaneously once a month until week 48.

Group Type ACTIVE_COMPARATOR

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Ezetimibe

Intervention Type DRUG

Tablet for oral administration

Placebo to Evolocumab

Intervention Type DRUG

Administered by subcutaneous injection

Evolocumab Q2W

Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for 12 weeks. From week 12 participants received open-label evolocumab 140 mg subcutaneously once every 2 weeks until week 48.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Placebo Ezetimibe

Intervention Type DRUG

Tablet for oral administration

Evolocumab QM

Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for 12 weeks. From week 12 participants received open-label evolocumab 420 mg subcutaneously once a month until week 48.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Placebo Ezetimibe

Intervention Type DRUG

Tablet for oral administration

Interventions

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Evolocumab

Administered by subcutaneous injection

Intervention Type BIOLOGICAL

Ezetimibe

Tablet for oral administration

Intervention Type DRUG

Placebo to Evolocumab

Administered by subcutaneous injection

Intervention Type DRUG

Placebo Ezetimibe

Tablet for oral administration

Intervention Type DRUG

Other Intervention Names

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AMG 145 Repatha Zetia

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥ 20 to ≤ 80 years of age
* Japanese by self-identification
* Not on a statin or on a low dose statin with stable dose for at least 4 weeks.
* Subject not at LDL-C goal
* History of statin intolerance to at least 2 statins
* Lipid lowering therapy has been stable prior to screening for at least 4 weeks
* Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria

* New York Heart Association (NYHA) III or IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Type 1 diabetes
* Poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 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

Nagoya, Aichi-ken, Japan

Site Status

Research Site

Nagoya, Aichi-ken, Japan

Site Status

Research Site

Chiba, Chiba, Japan

Site Status

Research Site

Kisarazu-shi, Chiba, Japan

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Research Site

Matsudo-shi, Chiba, Japan

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Research Site

Chikushino-shi, Fukuoka, Japan

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Research Site

Koga-shi, Fukuoka, Japan

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Research Site

Sukagawa-shi, Fukushima, Japan

Site Status

Research Site

Sukagawa-shi, Fukushima, Japan

Site Status

Research Site

Hiroshima, Hiroshima, Japan

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Research Site

Kobe, Hyōgo, Japan

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Koga-shi, Ibaraki, Japan

Site Status

Research Site

Kahoku-gun, Ishikawa-ken, Japan

Site Status

Research Site

Kanazawa, Ishikawa-ken, Japan

Site Status

Research Site

Komatsu-shi, Ishikawa-ken, Japan

Site Status

Research Site

Morioka, Iwate, Japan

Site Status

Research Site

Morioka, Iwate, Japan

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Research Site

Kagoshima, Kagoshima-ken, Japan

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Research Site

Yokohama, Kanagawa, Japan

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Research Site

Kumamoto, Kumamoto, Japan

Site Status

Research Site

Kumamoto, Kumamoto, Japan

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Research Site

Kyoto, Kyoto, Japan

Site Status

Research Site

Ohsaki-shi, Miyagi, Japan

Site Status

Research Site

Nakagami-gun, Okinawa, Japan

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Research Site

Osaka, Osaka, Japan

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Research Site

Osaka, Osaka, Japan

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Research Site

Fujimi-shi, Saitama, Japan

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Research Site

Iruma-gun, Saitama, Japan

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Research Site

Kawaguchi-shi, Saitama, Japan

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Research Site

Hamamatsu, Shizuoka, Japan

Site Status

Research Site

Bunkyo-ku, Tokyo, Japan

Site Status

Research Site

Chuo-ku, Tokyo, Japan

Site Status

Research Site

Higashiyamato-shi, Tokyo, Japan

Site Status

Research Site

Musashino-shi, Tokyo, Japan

Site Status

Research Site

Shinagawa-ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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Koba S, Inoue I, Cyrille M, Lu C, Inomata H, Shimauchi J, Kajinami K. Evolocumab vs. Ezetimibe in Statin-Intolerant Hyperlipidemic Japanese Patients: Phase 3 GAUSS-4 Trial. J Atheroscler Thromb. 2020 May 1;27(5):471-484. doi: 10.5551/jat.50963. Epub 2019 Nov 21.

Reference Type DERIVED
PMID: 31748467 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20140234

Identifier Type: -

Identifier Source: org_study_id