Study of LDL-Cholesterol Reduction Using Evolocumab (AMG145) in Japanese Patients With Advanced Cardiovascular Risk

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01953328
First received: September 26, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

The primary hypothesis is that both dosing regimens of evolocumab (AMG 145) SC will be well tolerated and will result in greater reduction of LDL-C, compared with placebo, when used in combination with statin therapy in subjects with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.


Condition Intervention Phase
Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events
Drug: Statin
Other: Placebo
Biological: Study Drug
Phase 3

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 Safety, Tolerability and Efficacy of Evolocumab (AMG145) on LDL-C in Combination With Statin Therapy in Japanese Subjects With High Cardiovascular Risk and With Hyperlipidemia or Mixed Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Mean percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)

  • Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)


Secondary Outcome Measures:
  • Mean change from baseline in low density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean change from baseline in low density lipoprotein-cholesterol

  • Change from baseline in low density lipoprotein-cholesterol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in low density lipoprotein-cholesterol

  • Mean percent change from baseline in non-high density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in non-high density lipoprotein-cholesterol

  • Percent change from baseline in non-high density lipoprotein-cholesterol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in non-high density lipoprotein-cholesterol

  • Mean percent change from baseline in apolipoprotein B [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in apolipoprotein B

  • Percent change from baseline in apolipoprotein B [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in apolipoprotein B

  • Mean percent change from baseline in total cholesterol [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in total cholesterol

  • Percent change from baseline in total cholesterol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in total cholesterol

  • Mean percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio

  • Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio

  • Mean percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio

  • Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio

  • Mean low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L]) [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L])

  • Low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L]) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L])

  • Mean percent change from baseline in lipoprotein (a) [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in lipoprotein (a)

  • Percent change from baseline in lipoprotein (a) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in lipoprotein (a)

  • Mean percent change from baseline in triglycerides [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in triglycerides

  • Percent change from baseline in triglycerides [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in triglycerides

  • Mean percent change from baseline in high density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in high density lipoprotein-cholesterol

  • Percent change from baseline in high density lipoprotein-cholesterol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in high density lipoprotein-cholesterol

  • Mean percent change from baseline in very low-density lipoprotein cholesterol [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in very low-density lipoprotein cholesterol

  • Percent change from baseline in very low-density lipoprotein cholesterol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in very low-density lipoprotein cholesterol


Enrollment: 409
Study Start Date: September 2013
Estimated Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Statin (Arm A and Arm B)
Patients are randomized to a low and high dose of a statin; then subjects are randomized to one of the following: Arm 1, Arm 2, Arm 3 or Arm 4.
Drug: Statin
Patients are randomized to low and high dose of a statin; then subjects are randomized to one of the following:
Placebo Comparator: Arm 1
Dose 1 - placebo every two weeks - subcutaneous
Other: Placebo
All patients at screening will participate in the placebo run-in dosing subcutaneous. Patients will receive placebo every 2 weeks or monthly subcutaneous.
Experimental: Arm 2
Dose 2 - evolocumab (AMG 145) study drug every two weeks - subcutaneous
Biological: Study Drug
Patients will receive evolocumab (AMG145) every 2 weeks or monthly subcutaneous.
Placebo Comparator: Arm 3
Dose 3 - placebo once a month - subcutaneous
Other: Placebo
All patients at screening will participate in the placebo run-in dosing subcutaneous. Patients will receive placebo every 2 weeks or monthly subcutaneous.
Experimental: Arm 4
Dose 4 - evolocumab (AMG 145) study drug once a month - subcutaneous
Biological: Study Drug
Patients will receive evolocumab (AMG145) every 2 weeks or monthly subcutaneous.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Male or female, Japanese adult, 20-85 years of age; Subjects on stable dose of statin for greater than equal to 4 weeks; Fasting LDL-C greater than equal to 100 mg/dL; Fasting triglycerides less than equal to 400 mg/dL; Subject is at high risk for cardiovascular events. Exclusion Criteria: NYHA III or IV - heart failure; Uncontrolled cardiac arrhythmia; Uncontrolled hypertension; Type 1 diabetes, poorly controlled type 2 diabetes; Uncontrolled hypothyroidism or hyperthyroidism

  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: NCT01953328

  Hide Study Locations
Locations
Japan
Research Site
Akita-shi, Akita, Japan, 010-1423
Research Site
Noda-shi, Chiba, Japan, 278-0004
Research Site
Fukuoka-shi, Fukuoka, Japan, 810-0014
Research Site
Fukuoka-shi, Fukuoka, Japan, 810-0066
Research Site
Fukuoka-shi, Fukuoka, Japan, 819-8551
Research Site
Kitakyusyu-shi, Fukuoka, Japan, 807-0856
Research Site
Koriyama-shi, Fukushima, Japan, 963-8041
Research Site
Koriyama-shi, Fukushima, Japan, 963-8832
Research Site
Koriyama-shi, Fukushima, Japan, 963-8862
Research Site
Koriyama-shi, Fukushima, Japan, 963-0209
Research Site
Koriyama-shi, Fukushima, Japan, 963-8026
Research Site
Maebashi-shi, Gunma, Japan, 371-0022
Research Site
Takasaki-shi, Gunma, Japan, 370-3524
Research Site
Sapporo-shi, Hokkaido, Japan, 003-0026
Research Site
Sapporo-shi, Hokkaido, Japan, 003-0825
Research Site
Sapporo-shi, Hokkaido, Japan, 060-0063
Research Site
Tsuchiura-shi, Ibaraki, Japan, 300-0047
Research Site
Hanamaki-shi, Iwate, Japan, 025-0075
Research Site
Morioka-shi, Iwate, Japan, 020-0066
Research Site
Takamatsu-shi, Kagawa, Japan, 760-0076
Research Site
Takamatsu-shi, Kagawa, Japan, 760-0018
Research Site
Yokohama-shi, Kanagawa, Japan, 231-0023
Research Site
Kyoto-shi, Kyoto, Japan, 615-8125
Research Site
Sendai-shi, Miyagi, Japan, 983-0039
Research Site
Sendai-shi, Miyagi, Japan, 983-0835
Research Site
Sendai-shi, Miyagi, Japan, 989-3122
Research Site
Tomigusuku-shi, Okinawa, Japan, 901-0243
Research Site
Urasoe-shi, Okinawa, Japan, 901-2132
Research Site
Ibaraki-shi, Osaka, Japan, 567-0876
Research Site
Osaka-shi, Osaka, Japan, 530-0001
Research Site
Toyonaka-shi, Osaka, Japan, 560-0082
Research Site
Koshigaya-shi, Saitama, Japan, 343-0826
Research Site
Kumagaya-shi, Saitama, Japan, 360-0816
Research Site
Niiza-shi, Saitama, Japan, 352-0014
Research Site
Arakawa-ku, Tokyo, Japan, 116-0002
Research Site
Chiyoda-ku, Tokyo, Japan, 101-0041
Research Site
Chiyoda-ku, Tokyo, Japan, 101-0024
Research Site
Chofu-shi, Tokyo, Japan, 182-0006
Research Site
Chuo-ku, Tokyo, Japan, 103-0027
Research Site
Edogawa-ku, Tokyo, Japan, 133-0061
Research Site
Hachioji-shi, Tokyo, Japan, 192-0046
Research Site
Itabashi-ku, Tokyo, Japan, 173-8610
Research Site
Katsushika-ku, Tokyo, Japan, 124-0024
Research Site
Koto-ku, Tokyo, Japan, 135-0011
Research Site
Minato-ku, Tokyo, Japan, 105-7390
Research Site
Minato-ku, Tokyo, Japan, 108-0075
Research Site
Ota-ku, Tokyo, Japan, 144-0034
Research Site
Setagaya-ku, Tokyo, Japan, 155-0031
Research Site
Shibuya-ku, Tokyo, Japan, 150-0012
Research Site
Shinagawa-ku, Tokyo, Japan, 141-6003
Research Site
Shinagawa-ku, Tokyo, Japan, 141-0001
Research Site
Shinagawa-ku, Tokyo, Japan, 142-0053
Research Site
Shinagawa-ku, Tokyo, Japan, 140-0011
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: NCT01953328     History of Changes
Other Study ID Numbers: 20120122
Study First Received: September 26, 2013
Last Updated: July 7, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Amgen:
Japanese, high cholesterol, LDL-C, High Cardiovascular Risk

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014