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Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

NCT ID: NCT01953328

Last Updated: 2015-12-23

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

409 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-06-30

Brief Summary

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The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.

Detailed Description

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After a screening and placebo run-in period, eligible patients were randomized in a 1:1 ratio to 1 of 2 open-label background statin treatments (atorvastatin 5 mg or 20 mg daily \[QD\]) and entered a 4-week lipid stabilization period. After the lipid stabilization period, eligible patients were randomized in a 1:1:1:1 ratio to investigational product (evolocumab or placebo) for the 12-week treatment period.

Both randomizations were stratified by subject diagnosis and lipid-lowering therapy as follows:

* current or prior diagnosis of heterozygous familial hypercholesterolemia (HeFH)
* no diagnosis of HeFH and receiving intensive lipid-lowering therapy
* no diagnosis of HeFH and receiving non-intensive lipid-lowering therapy. A participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria including meeting final laboratory safety criteria, and undergoing both randomization procedures.

Conditions

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Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events

Keywords

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Japanese, high cholesterol, LDL-C, High Cardiovascular Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A5 Placebo Q2W

Participants received atorvastatin 5 mg (A5) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.

Group Type PLACEBO_COMPARATOR

Atorvastatin

Intervention Type DRUG

Administered orally once a day

Placebo to Evolocumab

Intervention Type OTHER

Administered by subcutaneous injection

A5 Placebo QM

Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.

Group Type PLACEBO_COMPARATOR

Atorvastatin

Intervention Type DRUG

Administered orally once a day

Placebo to Evolocumab

Intervention Type OTHER

Administered by subcutaneous injection

A5 Evolocumab Q2W

Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Administered orally once a day

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

A5 Evolocumab QM

Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Administered orally once a day

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

A20 Placebo Q2W

Participants received atorvastatin 20 mg (A20) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.

Group Type PLACEBO_COMPARATOR

Atorvastatin

Intervention Type DRUG

Administered orally once a day

Placebo to Evolocumab

Intervention Type OTHER

Administered by subcutaneous injection

A20 Placebo QM

Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.

Group Type OTHER

Atorvastatin

Intervention Type DRUG

Administered orally once a day

Placebo to Evolocumab

Intervention Type OTHER

Administered by subcutaneous injection

A20 Evolocumab Q2W

Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Administered orally once a day

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

A20 Evolocumab QM

Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Administered orally once a day

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Interventions

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Atorvastatin

Administered orally once a day

Intervention Type DRUG

Evolocumab

Administered by subcutaneous injection

Intervention Type BIOLOGICAL

Placebo to Evolocumab

Administered by subcutaneous injection

Intervention Type OTHER

Other Intervention Names

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Lipitor AMG 145 Repatha

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Male or female, Japanese adult, 20-85 years of age; Subjects on stable dose of statin for greater than equal to 4 weeks; Fasting LDL-C greater than equal to 100 mg/dL; Fasting triglycerides less than equal to 400 mg/dL; Subject is at high risk for cardiovascular events.

Exclusion Criteria

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

85 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

Akita, Akita, Japan

Site Status

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Noda, Chiba, Japan

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Fukuoka, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyusyu-shi, Fukuoka, Japan

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Koriyama-shi, Fukushima, Japan

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Koriyama-shi, Fukushima, Japan

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Koriyama-shi, Fukushima, Japan

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Koriyama-shi, Fukushima, Japan

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Koriyama-shi, Fukushima, Japan

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Maebashi, Gunma, Japan

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Takasaki-shi, Gunma, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Tsuchiura-shi, Ibaraki, Japan

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Hanamaki-shi, Iwate, Japan

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Morioka, Iwate, Japan

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Takamatsu, Kagawa-ken, Japan

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Takamatsu, Kagawa-ken, Japan

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Yokohama, Kanagawa, Japan

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Kyoto, Kyoto, Japan

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Sendai, Miyagi, Japan

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Sendai, Miyagi, Japan

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Sendai, Miyagi, Japan

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Tomigusuku-shi, Okinawa, Japan

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Urasoe-shi, Okinawa, Japan

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Ibaraki-shi, Osaka, Japan

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Osaka, Osaka, Japan

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Toyonaka-shi, Osaka, Japan

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Koshigaya-shi, Saitama, Japan

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Kumagaya-shi, Saitama, Japan

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Niiza-shi, Saitama, Japan

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Arakawa-ku, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Chofu-shi, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Edogawa-ku, Tokyo, Japan

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Hachioji-shi, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Katsushika-ku, Tokyo, Japan

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Koto-ku, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Shibuya-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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Countries

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Japan

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20120122

Identifier Type: -

Identifier Source: org_study_id