Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
AMG145
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) on LDL-C in Combination With Statin Therapy in Japanese Subjects With High Cardiovascular Risk and With Hyperlipidemia or Mixed Dyslipidemia
1 other identifier
interventional
409
1 country
54
Brief Summary
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2013
Shorter than P25 for phase_3
54 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
First Submitted
Initial submission to the registry
September 26, 2013
CompletedFirst Posted
Study publicly available on registry
September 30, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
December 23, 2015
CompletedDecember 23, 2015
November 1, 2015
8 months
September 26, 2013
September 23, 2015
November 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Baseline and Week 12
Secondary Outcomes (22)
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Baseline and Week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
- +17 more secondary outcomes
Study Arms (8)
A5 Placebo Q2W
PLACEBO COMPARATORParticipants received atorvastatin 5 mg (A5) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
A5 Placebo QM
PLACEBO COMPARATORParticipants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
A5 Evolocumab Q2W
EXPERIMENTALParticipants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
A5 Evolocumab QM
EXPERIMENTALParticipants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
A20 Placebo Q2W
PLACEBO COMPARATORParticipants received atorvastatin 20 mg (A20) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
A20 Placebo QM
OTHERParticipants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
A20 Evolocumab Q2W
EXPERIMENTALParticipants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
A20 Evolocumab QM
EXPERIMENTALParticipants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
Interventions
Administered orally once a day
Administered by subcutaneous injection
Administered by subcutaneous injection
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (54)
Research Site
Akita, Akita, 010-1423, Japan
Research Site
Noda, Chiba, 278-0004, Japan
Research Site
Fukuoka, Fukuoka, 810-0014, Japan
Research Site
Fukuoka, Fukuoka, 810-0066, Japan
Research Site
Fukuoka, Fukuoka, 819-8551, Japan
Research Site
Kitakyusyu-shi, Fukuoka, 807-0856, Japan
Research Site
Koriyama-shi, Fukushima, 963-0209, Japan
Research Site
Koriyama-shi, Fukushima, 963-8026, Japan
Research Site
Koriyama-shi, Fukushima, 963-8041, Japan
Research Site
Koriyama-shi, Fukushima, 963-8832, Japan
Research Site
Koriyama-shi, Fukushima, 963-8862, Japan
Research Site
Maebashi, Gunma, 371-0022, Japan
Research Site
Takasaki-shi, Gunma, 370-3524, Japan
Research Site
Sapporo, Hokkaido, 003-0026, Japan
Research Site
Sapporo, Hokkaido, 003-0825, Japan
Research Site
Sapporo, Hokkaido, 060-0063, Japan
Research Site
Tsuchiura-shi, Ibaraki, 300-0047, Japan
Research Site
Hanamaki-shi, Iwate, 025-0075, Japan
Research Site
Morioka, Iwate, 020-0066, Japan
Research Site
Takamatsu, Kagawa-ken, 760-0018, Japan
Research Site
Takamatsu, Kagawa-ken, 760-0076, Japan
Research Site
Yokohama, Kanagawa, 231-0023, Japan
Research Site
Kyoto, Kyoto, 615-8125, Japan
Research Site
Sendai, Miyagi, 983-0039, Japan
Research Site
Sendai, Miyagi, 983-0835, Japan
Research Site
Sendai, Miyagi, 989-3122, Japan
Research Site
Tomigusuku-shi, Okinawa, 901-0243, Japan
Research Site
Urasoe-shi, Okinawa, 901-2132, Japan
Research Site
Ibaraki-shi, Osaka, 567-0876, Japan
Research Site
Osaka, Osaka, 530-0001, Japan
Research Site
Toyonaka-shi, Osaka, 560-0082, Japan
Research Site
Koshigaya-shi, Saitama, 343-0826, Japan
Research Site
Kumagaya-shi, Saitama, 360-0816, Japan
Research Site
Niiza-shi, Saitama, 352-0014, Japan
Research Site
Arakawa-ku, Tokyo, 116-0002, Japan
Research Site
Chiyoda-ku, Tokyo, 101-0024, Japan
Research Site
Chiyoda-ku, Tokyo, 101-0041, Japan
Research Site
Chofu-shi, Tokyo, 182-0006, Japan
Research Site
Chuo-ku, Tokyo, 103-0027, Japan
Research Site
Edogawa-ku, Tokyo, 133-0061, Japan
Research Site
Hachioji-shi, Tokyo, 192-0046, Japan
Research Site
Itabashi-ku, Tokyo, 173-8610, Japan
Research Site
Katsushika-ku, Tokyo, 124-0024, Japan
Research Site
Koto-ku, Tokyo, 135-0011, Japan
Research Site
Minato-ku, Tokyo, 105-7390, Japan
Research Site
Minato-ku, Tokyo, 108-0075, Japan
Research Site
Ōta-ku, Tokyo, 144-0034, Japan
Research Site
Setagaya-ku, Tokyo, 155-0031, Japan
Research Site
Shibuya-ku, Tokyo, 150-0012, Japan
Research Site
Shinagawa-ku, Tokyo, 140-0011, Japan
Research Site
Shinagawa-ku, Tokyo, 141-0001, Japan
Research Site
Shinagawa-ku, Tokyo, 141-6003, Japan
Research Site
Shinagawa-ku, Tokyo, 142-0053, Japan
Research Site
Toshima-ku, Tokyo, 171-0021, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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 3
- 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
September 26, 2013
First Posted
September 30, 2013
Study Start
October 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
December 23, 2015
Results First Posted
December 23, 2015
Record last verified: 2015-11