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Study Complete
Sponsor ID
20110231

A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese SubjectsAMG145

Sponsor ID
20110231
Clinicaltrials.gov ID
NCT01652703
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
Evolocumab
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
310
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) at week 12

Timeframe: 12 Weeks

Secondary Outcome Measures

Change from baseline in LDL-C at week 12

Timeframe: Week 12

LDL-C response (<70 mg/dL [1.8 mmol/L]) at week 12

Timeframe: Week 12

Percent change from baseline to week 12 in the following lipid parameter - non High Density Lipoprotein Cholesterol (non-HDL-C)

Timeframe: Week 12

Percent change from baseline to week 12 in the following lipid parameter - Apolipoprotein B

Timeframe: Week 12

Percent change from baseline to week 12 in the following lipid parameter - Very Low Density Lipoprotein Cholesterol (VLDL-C)

Timeframe: Week 12

Percent change from baseline to week 12 in the following lipid parameter - total cholesterol/HDL-C ratio

Timeframe: Week 12

Percent change from baseline to week 12 in the following lipid parameter - Apolipoprotein B/Apolipoprotein A1 ratio

Timeframe: Week 12

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Chiyoda-ku, Tokyo, Japan, 101-0041
Status
Recruiting
Location
Research Site
Hachioji-shi, Tokyo, Japan, 192-0918
Status
Recruiting
Location
Research Site
Ibaraki-shi, Osaka, Japan, 567-0876
Status
Recruiting
Location
Research Site
Kasuga-shi, Fukuoka, Japan, 816-0864
Status
Recruiting
Location
Research Site
Kyoto-shi, Kyoto, Japan, 615-8125
Status
Recruiting
Location
Research Site
Maebashi-shi, Gunma, Japan, 371-0022
Status
Recruiting
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Study Info
Age
20 - 80 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Jul 2012 - May 2013
    Inclusion and Exclusion 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.