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
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
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.
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.
Kasuga-shi, Fukuoka 816-0864, Japan
Fujioka-shi, Gunma 375-0015, Japan
Takasaki-shi, Gunma 370-0829, Japan
Hitachi-shi, Ibaraki 317-0077, Japan
Koga-shi, Ibaraki 306-0041, Japan
Komatsu-shi, Ishikawa-ken 923-8560, Japan
Ina-shi, Nagano 396-8555, Japan
Matsumoto-shi, Nagano 390-0848, Japan
Suwa-shi, Nagano 392-8510, Japan
Ibaraki-shi, Osaka 567-0876, Japan
Suita-shi, Osaka 565-0871, Japan
Toyonaka-shi, Osaka 560-0082, Japan
Hanyu-shi, Saitama 348-8505, Japan
Sayama-shi, Saitama 350-1305, Japan
Toda-shi, Saitama 335-0023, Japan
Bunkyo-ku, Tokyo 113-8421, Japan
Bunkyo-ku, Tokyo 113-8519, Japan
Chiyoda-ku, Tokyo 101-0041, Japan
Chuo-ku, Tokyo 103-0027, Japan
Hachioji-shi, Tokyo 192-0918, Japan
Itabashi-ku, Tokyo 173-8610, Japan
Shinagawa-ku, Tokyo 141-0001, Japan
Taito-ku, Tokyo 111-0052, Japan
Toshima-ku, Tokyo 171-0021, Japan