A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
AMG145
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
1 other identifier
interventional
310
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2012
CompletedFirst Submitted
Initial submission to the registry
July 26, 2012
CompletedFirst Posted
Study publicly available on registry
July 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2013
CompletedResults Posted
Study results publicly available
October 5, 2015
CompletedNovember 28, 2018
November 1, 2018
10 months
July 26, 2012
September 3, 2015
November 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Baseline and Week 12
Percentage of Participants With an LDL-C Response at Week 12
Week 12
Percent Change From Baseline to Week 12 in Non-HDL-C
Baseline and Week 12
Percent Change From Baseline to Week 12 in Apolipoprotein B
Baseline and Week 12
Percent Change From Baseline to Week 12 in VLDL-C
Baseline and Week 12
- +2 more secondary outcomes
Study Arms (6)
Placebo Q2W
PLACEBO COMPARATORParticipants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Placebo Q4W
PLACEBO COMPARATORParticipants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Evolocumab 70 mg Q2W
EXPERIMENTALParticipants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 140 mg Q2W
EXPERIMENTALParticipants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 280 mg Q4W
EXPERIMENTALParticipants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 420 mg Q4W
EXPERIMENTALParticipants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Interventions
Administered by subcutaneous injection
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (42)
Research Site
Nagoya, Aichi-ken, 454-0933, Japan
Research Site
Nagoya, Aichi-ken, 455-8530, Japan
Research Site
Nagoya, Aichi-ken, 462-0825, Japan
Research Site
Fukui-shi, Fukui, 910-0067, Japan
Research Site
Fukui-shi, Fukui, 910-0803, Japan
Research Site
Fukui-shi, Fukui, 910-0837, Japan
Research Site
Kasuga-shi, Fukuoka, 816-0864, Japan
Research Site
Gifu, Gifu, 500-8384, Japan
Research Site
Fujioka-shi, Gunma, 375-0015, Japan
Research Site
Maebashi, Gunma, 371-0022, Japan
Research Site
Maebashi, Gunma, 371-0046, Japan
Research Site
Takasaki-shi, Gunma, 370-0829, Japan
Research Site
Kawanishi, Hyōgo, 666-0125, Japan
Research Site
Kobe, Hyōgo, 657-0068, Japan
Research Site
Hitachi-shi, Ibaraki, 317-0077, Japan
Research Site
Koga-shi, Ibaraki, 306-0041, Japan
Research Site
Mito, Ibaraki, 311-4198, Japan
Research Site
Komatsu-shi, Ishikawa-ken, 923-8560, Japan
Research Site
Takamatsu, Kagawa-ken, 760-8557, Japan
Research Site
Kochi, Kochi, 781-8555, Japan
Research Site
Kumamoto, Kumamoto, 860-8556, Japan
Research Site
Kyoto, Kyoto, 613-0911, Japan
Research Site
Kyoto, Kyoto, 615-8125, Japan
Research Site
Ina-shi, Nagano, 396-8555, Japan
Research Site
Matsumoto-shi, Nagano, 390-0848, Japan
Research Site
Suwa-shi, Nagano, 392-8510, Japan
Research Site
Ibaraki-shi, Osaka, 567-0876, Japan
Research Site
Suita-shi, Osaka, 565-0871, Japan
Research Site
Toyonaka-shi, Osaka, 560-0082, Japan
Research Site
Hanyu-shi, Saitama, 348-8505, Japan
Research Site
Sayama-shi, Saitama, 350-1305, Japan
Research Site
Toda-shi, Saitama, 335-0023, Japan
Research Site
Ōtsu, Shiga, 520-0113, Japan
Research Site
Bunkyo-ku, Tokyo, 113-8421, Japan
Research Site
Bunkyo-ku, Tokyo, 113-8519, Japan
Research Site
Chiyoda-ku, Tokyo, 101-0041, Japan
Research Site
Chuo-ku, Tokyo, 103-0027, Japan
Research Site
Hachioji-shi, Tokyo, 192-0918, Japan
Research Site
Itabashi-ku, Tokyo, 173-8610, Japan
Research Site
Shinagawa-ku, Tokyo, 141-0001, Japan
Research Site
Taito-ku, Tokyo, 111-0052, Japan
Research Site
Toshima-ku, Tokyo, 171-0021, Japan
Related Publications (3)
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.
PMID: 28367845BACKGROUNDToth 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.
PMID: 28249876BACKGROUNDKasichayanula 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.
PMID: 29353350BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2012
First Posted
July 30, 2012
Study Start
July 10, 2012
Primary Completion
May 14, 2013
Last Updated
November 28, 2018
Results First Posted
October 5, 2015
Record last verified: 2018-11