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

Primary Purpose

Hypercholesterolemia and High Risk for Cardiovascular Events

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Evolocumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia and High Risk for Cardiovascular Events focused on measuring Japanese, hypercholesterolemia, high risk for cardiovascular events

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo Q2W

Placebo Q4W

Evolocumab 70 mg Q2W

Evolocumab 140 mg Q2W

Evolocumab 280 mg Q4W

Evolocumab 420 mg Q4W

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
LDL-C was measured using ultracentrifugation.

Secondary Outcome Measures

Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
LDL-C was measured using ultracentrifugation.
Percentage of Participants With an LDL-C Response at 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.
Percent Change From Baseline to Week 12 in Non-HDL-C
Percent Change From Baseline to Week 12 in Apolipoprotein B
Percent Change From Baseline to Week 12 in VLDL-C
Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio
Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio

Full Information

First Posted
July 26, 2012
Last Updated
November 1, 2018
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01652703
Brief Title
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
Acronym
AMG145
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 10, 2012 (Actual)
Primary Completion Date
May 14, 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia and High Risk for Cardiovascular Events
Keywords
Japanese, hypercholesterolemia, high risk for cardiovascular events

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Q2W
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Arm Title
Placebo Q4W
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Arm Title
Evolocumab 70 mg Q2W
Arm Type
Experimental
Arm Description
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Arm Title
Evolocumab 140 mg Q2W
Arm Type
Experimental
Arm Description
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Arm Title
Evolocumab 280 mg Q4W
Arm Type
Experimental
Arm Description
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Arm Title
Evolocumab 420 mg Q4W
Arm Type
Experimental
Arm Description
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Administered by subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Description
LDL-C was measured using ultracentrifugation.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Description
LDL-C was measured using ultracentrifugation.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an LDL-C Response at Week 12
Description
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.
Time Frame
Week 12
Title
Percent Change From Baseline to Week 12 in Non-HDL-C
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline to Week 12 in Apolipoprotein B
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline to Week 12 in VLDL-C
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
454-0933
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
462-0825
Country
Japan
Facility Name
Research Site
City
Fukui-shi
State/Province
Fukui
ZIP/Postal Code
910-0067
Country
Japan
Facility Name
Research Site
City
Fukui-shi
State/Province
Fukui
ZIP/Postal Code
910-0803
Country
Japan
Facility Name
Research Site
City
Fukui-shi
State/Province
Fukui
ZIP/Postal Code
910-0837
Country
Japan
Facility Name
Research Site
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816-0864
Country
Japan
Facility Name
Research Site
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
500-8384
Country
Japan
Facility Name
Research Site
City
Fujioka-shi
State/Province
Gunma
ZIP/Postal Code
375-0015
Country
Japan
Facility Name
Research Site
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-0022
Country
Japan
Facility Name
Research Site
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-0046
Country
Japan
Facility Name
Research Site
City
Takasaki-shi
State/Province
Gunma
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
Research Site
City
Kawani-shi
State/Province
Hyogo
ZIP/Postal Code
666-0125
Country
Japan
Facility Name
Research Site
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
657-0068
Country
Japan
Facility Name
Research Site
City
Hitachi-shi
State/Province
Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Research Site
City
Koga-shi
State/Province
Ibaraki
ZIP/Postal Code
306-0041
Country
Japan
Facility Name
Research Site
City
Mito-shi
State/Province
Ibaraki
ZIP/Postal Code
311-4198
Country
Japan
Facility Name
Research Site
City
Komatsu-shi
State/Province
Ishikawa
ZIP/Postal Code
923-8560
Country
Japan
Facility Name
Research Site
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Research Site
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
Research Site
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
613-0911
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
615-8125
Country
Japan
Facility Name
Research Site
City
Ina-shi
State/Province
Nagano
ZIP/Postal Code
396-8555
Country
Japan
Facility Name
Research Site
City
Matsumoto-shi
State/Province
Nagano
ZIP/Postal Code
390-0848
Country
Japan
Facility Name
Research Site
City
Suwa-shi
State/Province
Nagano
ZIP/Postal Code
392-8510
Country
Japan
Facility Name
Research Site
City
Ibaraki-shi
State/Province
Osaka
ZIP/Postal Code
567-0876
Country
Japan
Facility Name
Research Site
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Research Site
City
Toyonaka-shi
State/Province
Osaka
ZIP/Postal Code
560-0082
Country
Japan
Facility Name
Research Site
City
Hanyu-shi
State/Province
Saitama
ZIP/Postal Code
348-8505
Country
Japan
Facility Name
Research Site
City
Sayama-shi
State/Province
Saitama
ZIP/Postal Code
350-1305
Country
Japan
Facility Name
Research Site
City
Toda-shi
State/Province
Saitama
ZIP/Postal Code
335-0023
Country
Japan
Facility Name
Research Site
City
Otsu-shi
State/Province
Shiga
ZIP/Postal Code
520-0113
Country
Japan
Facility Name
Research Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8421
Country
Japan
Facility Name
Research Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Research Site
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-0041
Country
Japan
Facility Name
Research Site
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Research Site
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Research Site
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-0001
Country
Japan
Facility Name
Research Site
City
Taito-ku
State/Province
Tokyo
ZIP/Postal Code
111-0052
Country
Japan
Facility Name
Research Site
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0021
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28367845
Citation
Hirayama A, Yamashita S, Inomata H, Kassahun H, Cyrille M, Ruzza A, Yoshida M, Kiyosue A, Ma Y, Teramoto T. One-Year Efficacy and Safety of Evolocumab in Japanese Patients - A Pooled Analysis From the Open-Label Extension OSLER Studies. Circ J. 2017 Jun 23;81(7):1029-1035. doi: 10.1253/circj.CJ-16-1016. Epub 2017 Mar 29.
Results Reference
background
PubMed Identifier
28249876
Citation
Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.
Results Reference
background
PubMed Identifier
29353350
Citation
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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