A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
NCT ID: NCT01652703
Last Updated: 2018-11-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
310 participants
INTERVENTIONAL
2012-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Placebo
Administered by subcutaneous injection
Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Placebo
Administered by subcutaneous injection
Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Interventions
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Evolocumab
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Nagoya, Aichi-ken, Japan
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Fukui-shi, Fukui, Japan
Research Site
Fukui-shi, Fukui, Japan
Research Site
Fukui-shi, Fukui, Japan
Research Site
Kasuga-shi, Fukuoka, Japan
Research Site
Gifu, Gifu, Japan
Research Site
Fujioka-shi, Gunma, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Takasaki-shi, Gunma, Japan
Research Site
Kawanishi, Hyōgo, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Hitachi-shi, Ibaraki, Japan
Research Site
Koga-shi, Ibaraki, Japan
Research Site
Mito, Ibaraki, Japan
Research Site
Komatsu-shi, Ishikawa-ken, Japan
Research Site
Takamatsu, Kagawa-ken, Japan
Research Site
Kochi, Kochi, Japan
Research Site
Kumamoto, Kumamoto, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Ina-shi, Nagano, Japan
Research Site
Matsumoto-shi, Nagano, Japan
Research Site
Suwa-shi, Nagano, Japan
Research Site
Ibaraki-shi, Osaka, Japan
Research Site
Suita-shi, Osaka, Japan
Research Site
Toyonaka-shi, Osaka, Japan
Research Site
Hanyu-shi, Saitama, Japan
Research Site
Sayama-shi, Saitama, Japan
Research Site
Toda-shi, Saitama, Japan
Research Site
Ōtsu, Shiga, 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
Hachioji-shi, Tokyo, Japan
Research Site
Itabashi-ku, Tokyo, Japan
Research Site
Shinagawa-ku, Tokyo, Japan
Research Site
Taito-ku, Tokyo, Japan
Research Site
Toshima-ku, Tokyo, Japan
Countries
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References
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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.
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.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20110231
Identifier Type: -
Identifier Source: org_study_id
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