A Double-blind, Randomized, Placebo-controlled, Multicenter 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: January 13, 2014
Last verified: January 2014
  Purpose

Study conducted in Japanese subjects with hypercholesterolemia and high cardiovascular risk. Subjects will receive study drug either every 2 or every 4 weeks for a total of 12 weeks. Subjects will continue on their stable dose of statin +/- ezetimibe.


Condition Intervention Phase
Hypercholesterolemia and High Risk for Cardiovascular Events
Other: Placebo
Biological: Evolocumab (AMG 145)
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 Evolocumab (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: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in LDL-C at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • LDL-C response (<70 mg/dL [1.8 mmol/L]) at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percent change from baseline to week 12 in the following lipid parameter - non High Density Lipoprotein Cholesterol (non-HDL-C) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percent change from baseline to week 12 in the following lipid parameter - Apolipoprotein B [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percent change from baseline to week 12 in the following lipid parameter - Very Low Density Lipoprotein Cholesterol (VLDL-C) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percent change from baseline to week 12 in the following lipid parameter - total cholesterol/HDL-C ratio [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percent change from baseline to week 12 in the following lipid parameter - Apolipoprotein B/Apolipoprotein A1 ratio [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Dose 1 - evolocumab (AMG 145), every 2 weeks subcutaneous
Biological: Evolocumab (AMG 145)
Patients will receive evolocumab (AMG 145) every 2 or 4 weeks, subcutaneously
Placebo Comparator: Arm 2
Placebo, every 2 weeks subcutaneous
Other: Placebo
Patients will receive Placebo every 2 or 4 weeks, subcutaneously. All patients at screening will participate in the placebo run-in
Other Name: Subcutaneous Injection
Experimental: Arm 3
Dose 2 - evolocumab (AMG 145), every 2 weeks subcutaneous
Biological: Evolocumab (AMG 145)
Patients will receive evolocumab (AMG 145) every 2 or 4 weeks, subcutaneously
Experimental: Arm 4
Dose 3 - evolocumab (AMG 145), every 4 weeks subcutaneous
Biological: Evolocumab (AMG 145)
Patients will receive evolocumab (AMG 145) every 2 or 4 weeks, subcutaneously
Experimental: Arm 5
Dose 4 - evolocumab (AMG 145), every 4 weeks subcutaneous
Biological: Evolocumab (AMG 145)
Patients will receive evolocumab (AMG 145) every 2 or 4 weeks, subcutaneously
Placebo Comparator: Arm 6
Placebo, every 4 weeks subcutaneous
Other: Placebo
Patients will receive Placebo every 2 or 4 weeks, subcutaneously. All patients at screening will participate in the placebo run-in
Other Name: Subcutaneous Injection

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652703

Locations
Japan
Research Site
Nagoya-shi, Aichi, Japan, 455-8530
Research Site
Nagoya-shi, Aichi, Japan, 462-0825
Research Site
Nagoya-shi, Aichi, Japan, 454-0933
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, 371-0046
Research Site
Maebashi-shi, Gunma, Japan, 371-0022
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, 615-8125
Research Site
Kyoto-shi, Kyoto, Japan, 613-0911
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, 113-8519
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
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01652703     History of Changes
Other Study ID Numbers: 20110231
Study First Received: July 26, 2012
Last Updated: January 13, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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 April 15, 2014