Hypercholesterolemia and High Risk for Cardiovascular Events Clinical Trial
— AMG145Official 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
| NCT number | NCT01652703 |
| Other study ID # | 20110231 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | July 10, 2012 |
| Verified date | November 2018 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 310 |
| Est. completion date | |
| Est. primary completion date | May 14, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Bunkyo-ku | Tokyo |
| Japan | Research Site | Bunkyo-ku | Tokyo |
| Japan | Research Site | Chiyoda-ku | Tokyo |
| Japan | Research Site | Chuo-ku | Tokyo |
| Japan | Research Site | Fujioka-shi | Gunma |
| Japan | Research Site | Fukui-shi | Fukui |
| Japan | Research Site | Fukui-shi | Fukui |
| Japan | Research Site | Fukui-shi | Fukui |
| Japan | Research Site | Gifu-shi | Gifu |
| Japan | Research Site | Hachioji-shi | Tokyo |
| Japan | Research Site | Hanyu-shi | Saitama |
| Japan | Research Site | Hitachi-shi | Ibaraki |
| Japan | Research Site | Ibaraki-shi | Osaka |
| Japan | Research Site | Ina-shi | Nagano |
| Japan | Research Site | Itabashi-ku | Tokyo |
| Japan | Research Site | Kasuga-shi | Fukuoka |
| Japan | Research Site | Kawani-shi | Hyogo |
| Japan | Research Site | Kobe-shi | Hyogo |
| Japan | Research Site | Kochi-shi | Kochi |
| Japan | Research Site | Koga-shi | Ibaraki |
| Japan | Research Site | Komatsu-shi | Ishikawa |
| Japan | Research Site | Kumamoto-shi | Kumamoto |
| Japan | Research Site | Kyoto-shi | Kyoto |
| Japan | Research Site | Kyoto-shi | Kyoto |
| Japan | Research Site | Maebashi-shi | Gunma |
| Japan | Research Site | Maebashi-shi | Gunma |
| Japan | Research Site | Matsumoto-shi | Nagano |
| Japan | Research Site | Mito-shi | Ibaraki |
| Japan | Research Site | Nagoya-shi | Aichi |
| Japan | Research Site | Nagoya-shi | Aichi |
| Japan | Research Site | Nagoya-shi | Aichi |
| Japan | Research Site | Otsu-shi | Shiga |
| Japan | Research Site | Sayama-shi | Saitama |
| Japan | Research Site | Shinagawa-ku | Tokyo |
| Japan | Research Site | Suita-shi | Osaka |
| Japan | Research Site | Suwa-shi | Nagano |
| Japan | Research Site | Taito-ku | Tokyo |
| Japan | Research Site | Takamatsu-shi | Kagawa |
| Japan | Research Site | Takasaki-shi | Gunma |
| Japan | Research Site | Toda-shi | Saitama |
| Japan | Research Site | Toshima-ku | Tokyo |
| Japan | Research Site | Toyonaka-shi | Osaka |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
Japan,
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. — View 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. Review. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | LDL-C was measured using ultracentrifugation. | Baseline and Week 12 | |
| Secondary | Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | LDL-C was measured using ultracentrifugation. | Baseline and Week 12 | |
| Secondary | Percentage of Participants With an LDL-C Response at 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. | Week 12 | |
| Secondary | Percent Change From Baseline to Week 12 in Non-HDL-C | Baseline and Week 12 | ||
| Secondary | Percent Change From Baseline to Week 12 in Apolipoprotein B | Baseline and Week 12 | ||
| Secondary | Percent Change From Baseline to Week 12 in VLDL-C | Baseline and Week 12 | ||
| Secondary | Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio | Baseline and Week 12 | ||
| Secondary | Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio | Baseline and Week 12 |