A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects (AMG145)

November 1, 2018 updated by: Amgen

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Stable Statin Therapy in Japanese Subjects With Hypercholesterolemia and High Cardiovascular Risk

The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in Japanese adults with hypercholesterolemia and high cardiovascular risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

310

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 455-8530
        • Research Site
      • Nagoya-shi, Aichi, Japan, 454-0933
        • Research Site
      • Nagoya-shi, Aichi, Japan, 462-0825
        • Research Site
    • Fukui
      • Fukui-shi, Fukui, Japan, 910-0067
        • Research Site
      • Fukui-shi, Fukui, Japan, 910-0837
        • Research Site
      • Fukui-shi, Fukui, Japan, 910-0803
        • Research Site
    • Fukuoka
      • Kasuga-shi, Fukuoka, Japan, 816-0864
        • Research Site
    • Gifu
      • Gifu-shi, Gifu, Japan, 500-8384
        • Research Site
    • Gunma
      • Fujioka-shi, Gunma, Japan, 375-0015
        • Research Site
      • Maebashi-shi, Gunma, Japan, 371-0022
        • Research Site
      • Maebashi-shi, Gunma, Japan, 371-0046
        • Research Site
      • Takasaki-shi, Gunma, Japan, 370-0829
        • Research Site
    • Hyogo
      • Kawani-shi, Hyogo, Japan, 666-0125
        • Research Site
      • Kobe-shi, Hyogo, Japan, 657-0068
        • Research Site
    • Ibaraki
      • Hitachi-shi, Ibaraki, Japan, 317-0077
        • Research Site
      • Koga-shi, Ibaraki, Japan, 306-0041
        • Research Site
      • Mito-shi, Ibaraki, Japan, 311-4198
        • Research Site
    • Ishikawa
      • Komatsu-shi, Ishikawa, Japan, 923-8560
        • Research Site
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 760-8557
        • Research Site
    • Kochi
      • Kochi-shi, Kochi, Japan, 781-8555
        • Research Site
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 860-8556
        • Research Site
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 615-8125
        • Research Site
      • Kyoto-shi, Kyoto, Japan, 613-0911
        • Research Site
    • Nagano
      • Ina-shi, Nagano, Japan, 396-8555
        • Research Site
      • Matsumoto-shi, Nagano, Japan, 390-0848
        • Research Site
      • Suwa-shi, Nagano, Japan, 392-8510
        • Research Site
    • Osaka
      • Ibaraki-shi, Osaka, Japan, 567-0876
        • Research Site
      • Suita-shi, Osaka, Japan, 565-0871
        • Research Site
      • Toyonaka-shi, Osaka, Japan, 560-0082
        • Research Site
    • Saitama
      • Hanyu-shi, Saitama, Japan, 348-8505
        • Research Site
      • Sayama-shi, Saitama, Japan, 350-1305
        • Research Site
      • Toda-shi, Saitama, Japan, 335-0023
        • Research Site
    • Shiga
      • Otsu-shi, Shiga, Japan, 520-0113
        • Research Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Research Site
      • Bunkyo-ku, Tokyo, Japan, 113-8421
        • Research Site
      • Chiyoda-ku, Tokyo, Japan, 101-0041
        • Research Site
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Research Site
      • Hachioji-shi, Tokyo, Japan, 192-0918
        • Research Site
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Research Site
      • Shinagawa-ku, Tokyo, Japan, 141-0001
        • Research Site
      • Taito-ku, Tokyo, Japan, 111-0052
        • Research Site
      • Toshima-ku, Tokyo, Japan, 171-0021
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Japanese adult, on statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, fasting LDL-C greater than or equal to 115 mg/dL (3.0 mmol/L), fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L); Exclusion Criteria: New York Heart Association (NYHA) class III or IV, poorly controlled hypertension, recently diagnosed or poorly controlled type 2 diabetes, last known left ventricular ejection fraction < 30%, myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), stroke, planned cardiac surgery or revascularization within 6 months of randomization, uncontrolled cardiac arrhythmia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Other: Placebo
Administered by subcutaneous injection
Placebo Comparator: Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Other: Placebo
Administered by subcutaneous injection
Experimental: Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Experimental: Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Experimental: Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Experimental: Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline and Week 12
LDL-C was measured using ultracentrifugation.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline and Week 12
LDL-C was measured using ultracentrifugation.
Baseline and Week 12
Percentage of Participants With an LDL-C Response at Week 12
Time Frame: Week 12
An LDL-C response was defined as LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12. LDL-C was measured using ultracentrifugation.
Week 12
Percent Change From Baseline to Week 12 in Non-HDL-C
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline to Week 12 in Apolipoprotein B
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline to Week 12 in VLDL-C
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio
Time Frame: Baseline and Week 12
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2012

Primary Completion (Actual)

May 14, 2013

Study Registration Dates

First Submitted

July 26, 2012

First Submitted That Met QC Criteria

July 26, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110231

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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