We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    evolocumab, 20110231
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01652703
Recruitment Status : Completed
First Posted : July 30, 2012
Results First Posted : October 5, 2015
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Actual Study Start Date : July 10, 2012
Actual Primary Completion Date : May 14, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

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:
  • 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Percent Change From Baseline to Week 12 in Non-HDL-C [ Time Frame: Baseline and Week 12 ]
  4. Percent Change From Baseline to Week 12 in Apolipoprotein B [ Time Frame: Baseline and Week 12 ]
  5. Percent Change From Baseline to Week 12 in VLDL-C [ Time Frame: Baseline and Week 12 ]
  6. Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio [ Time Frame: Baseline and Week 12 ]
  7. Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio [ Time Frame: Baseline and Week 12 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652703


Locations
Layout table for location information
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
Layout table for investigator information
Study Director: MD Amgen
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01652703    
Other Study ID Numbers: 20110231
First Posted: July 30, 2012    Key Record Dates
Results First Posted: October 5, 2015
Last Update Posted: November 28, 2018
Last Verified: November 2018
Keywords provided by Amgen:
Japanese, hypercholesterolemia, high risk for cardiovascular events
Additional relevant MeSH terms:
Layout table for MeSH terms
Evolocumab
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents