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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01652703
First received: July 26, 2012
Last updated: September 3, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Hypercholesterolemia and High Risk for Cardiovascular Events
Biological: Evolocumab
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    LDL-C was measured using ultracentrifugation.


Secondary Outcome Measures:
  • Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    LDL-C was measured using ultracentrifugation.

  • Percentage of Participants With an LDL-C Response at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline to Week 12 in Apolipoprotein B [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline to Week 12 in VLDL-C [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • AMG 145
  • Repatha
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:
  • AMG 145
  • Repatha
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:
  • AMG 145
  • Repatha
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:
  • AMG 145
  • Repatha

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652703

Locations
Japan
Research Site
Nagoya-shi, Aichi, Japan, 454-0933
Research Site
Nagoya-shi, Aichi, Japan, 455-8530
Research Site
Nagoya-shi, Aichi, Japan, 462-0825
Research Site
Fukui-shi, Fukui, Japan, 910-0067
Research Site
Fukui-shi, Fukui, Japan, 910-0803
Research Site
Fukui-shi, Fukui, Japan, 910-0837
Research Site
Kasuga-shi, Fukuoka, Japan, 816-0864
Research Site
Gifu-shi, Gifu, Japan, 500-8384
Research Site
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
Kawani-shi, Hyogo, Japan, 666-0125
Research Site
Kobe-shi, Hyogo, Japan, 657-0068
Research Site
Hitachi-shi, Ibaraki, Japan, 317-0077
Research Site
Koga-shi, Ibaraki, Japan, 306-0041
Research Site
Mito-shi, Ibaraki, Japan, 311-4198
Research Site
Komatsu-shi, Ishikawa, Japan, 923-8560
Research Site
Takamatsu-shi, Kagawa, Japan, 760-8557
Research Site
Kochi-shi, Kochi, Japan, 781-8555
Research Site
Kumamoto-shi, Kumamoto, Japan, 860-8556
Research Site
Kyoto-shi, Kyoto, Japan, 613-0911
Research Site
Kyoto-shi, Kyoto, Japan, 615-8125
Research Site
Ina-shi, Nagano, Japan, 396-8555
Research Site
Matsumoto-shi, Nagano, Japan, 390-0848
Research Site
Suwa-shi, Nagano, Japan, 392-8510
Research Site
Ibaraki-shi, Osaka, Japan, 567-0876
Research Site
Suita-shi, Osaka, Japan, 565-0871
Research Site
Toyonaka-shi, Osaka, Japan, 560-0082
Research Site
Hanyu-shi, Saitama, Japan, 348-8505
Research Site
Sayama-shi, Saitama, Japan, 350-1305
Research Site
Toda-shi, Saitama, Japan, 335-0023
Research Site
Otsu-shi, Shiga, Japan, 520-0113
Research Site
Bunkyo-ku, Tokyo, Japan, 113-8421
Research Site
Bunkyo-ku, Tokyo, Japan, 113-8519
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
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01652703     History of Changes
Other Study ID Numbers: 20110231 
Study First Received: July 26, 2012
Results First Received: September 3, 2015
Last Updated: September 3, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
Japanese, hypercholesterolemia, high risk for cardiovascular events

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 24, 2016