Clinical trial NCT01652703: A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia and High Risk for Cardiovascular Events
Keywords: Japanese, hypercholesterolemia, high risk for cardiovascular events
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-07-30
Enrollment: 310
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With an LDL-C Response at Week 12
timeFrame: Week 12
measure: Percent Change From Baseline to Week 12 in Non-HDL-C
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline to Week 12 in Apolipoprotein B
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline to Week 12 in VLDL-C
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Fukui-shi
country: Japan
facility: Research Site
state: Fukui
city: Fukui-shi
country: Japan
facility: Research Site
state: Fukui
city: Fukui-shi
country: Japan
facility: Research Site
state: Fukui
city: Kasuga-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Research Site
state: Gifu
city: Fujioka-shi
country: Japan
facility: Research Site
state: Gunma
city: Maebashi-shi
country: Japan
facility: Research Site
state: Gunma
city: Maebashi-shi
country: Japan
facility: Research Site
state: Gunma
city: Takasaki-shi
country: Japan
facility: Research Site
state: Gunma
city: Kawani-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kobe-shi
country: Japan
facility: Research Site
state: Hyogo
city: Hitachi-shi
country: Japan
facility: Research Site
state: Ibaraki
city: Koga-shi
country: Japan
facility: Research Site
state: Ibaraki
city: Mito-shi
country: Japan
facility: Research Site
state: Ibaraki
city: Komatsu-shi
country: Japan
facility: Research Site
state: Ishikawa
city: Takamatsu-shi
country: Japan
facility: Research Site
state: Kagawa
city: Kochi-shi
country: Japan
facility: Research Site
state: Kochi
city: Kumamoto-shi
country: Japan
facility: Research Site
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: Research Site
state: Kyoto
city: Kyoto-shi
country: Japan
facility: Research Site
state: Kyoto
city: Ina-shi
country: Japan
facility: Research Site
state: Nagano
city: Matsumoto-shi
country: Japan
facility: Research Site
state: Nagano
city: Suwa-shi
country: Japan
facility: Research Site
state: Nagano
city: Ibaraki-shi
country: Japan
facility: Research Site
state: Osaka
city: Suita-shi
country: Japan
facility: Research Site
state: Osaka
city: Toyonaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Hanyu-shi
country: Japan
facility: Research Site
state: Saitama
city: Sayama-shi
country: Japan
facility: Research Site
state: Saitama
city: Toda-shi
country: Japan
facility: Research Site
state: Saitama
city: Otsu-shi
country: Japan
facility: Research Site
state: Shiga
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Research Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Taito-ku
country: Japan
facility: Research Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Research Site
state: Tokyo
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Hirayama A, Yamashita S, Inomata H, Kassahun H, Cyrille M, Ruzza A, Yoshida M, Kiyosue A, Ma Y, Teramoto T. One-Year Efficacy and Safety of Evolocumab in Japanese Patients - A Pooled Analysis From the Open-Label Extension OSLER Studies. Circ J. 2017 Jun 23;81(7):1029-1035. doi: 10.1253/circj.CJ-16-1016. Epub 2017 Mar 29.
citation: Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.
citation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.