A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 in Japanese Subjects (AMG145)
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01652703
First received: July 26, 2012
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
Study conducted in Japanese subjects with hypercholesterolemia and high cardiovascular risk. Subjects will receive study drug either every 2 or every 4 weeks for a total of 12 weeks. Subjects will continue on their stable dose of statin +/- ezetimibe.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia and High Risk for Cardiovascular Events |
Other: Placebo Biological: AMG 145 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) at week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in LDL-C at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- LDL-C response (<70 mg/dL [1.8 mmol/L]) at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Percent change from baseline to week 12 in the following lipid parameter - non High Density Lipoprotein Cholesterol (non-HDL-C) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Percent change from baseline to week 12 in the following lipid parameter - Apolipoprotein B [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Percent change from baseline to week 12 in the following lipid parameter - Very Low Density Lipoprotein Cholesterol (VLDL-C) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Percent change from baseline to week 12 in the following lipid parameter - total cholesterol/HDL-C ratio [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Percent change from baseline to week 12 in the following lipid parameter - Apolipoprotein B/Apolipoprotein A1 ratio [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Dose 1 - AMG 145, every 2 weeks subcutaneous
|
Biological: AMG 145
Patients will receive AMG 145 every 2 or 4 weeks, subcutaneously
|
|
Placebo Comparator: Arm 2
Placebo, every 2 weeks subcutaneous
|
Other: Placebo
Patients will receive Placebo every 2 or 4 weeks, subcutaneously. All patients at screening will participate in the placebo run-in
Other Name: Subcutaneous Injection
|
|
Experimental: Arm 3
Dose 2 - AMG 145, every 2 weeks subcutaneous
|
Biological: AMG 145
Patients will receive AMG 145 every 2 or 4 weeks, subcutaneously
|
|
Experimental: Arm 4
Dose 3 - AMG 145, every 4 weeks subcutaneous
|
Biological: AMG 145
Patients will receive AMG 145 every 2 or 4 weeks, subcutaneously
|
|
Experimental: Arm 5
Dose 4 - AMG 145, every 4 weeks subcutaneous
|
Biological: AMG 145
Patients will receive AMG 145 every 2 or 4 weeks, subcutaneously
|
|
Placebo Comparator: Arm 6
Placebo, every 4 weeks subcutaneous
|
Other: Placebo
Patients will receive Placebo every 2 or 4 weeks, subcutaneously. All patients at screening will participate in the placebo run-in
Other Name: Subcutaneous Injection
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652703
Locations
| Japan | |
| Research Site | |
| Nagoya-shi, Aichi, Japan, 455-8530 | |
| Research Site | |
| Nagoya-shi, Aichi, Japan, 462-0825 | |
| Research Site | |
| Nagoya-shi, Aichi, Japan, 454-0933 | |
| Research Site | |
| Fukui-shi, Fukui, Japan, 910-0067 | |
| Research Site | |
| Fukui-shi, Fukui, Japan, 910-0803 | |
| Research Site | |
| Kasuga-shi, Fukuoka, Japan, 816-0864 | |
| Research Site | |
| Gifu-shi, Gifu, Japan, 500-8384 | |
| Research Site | |
| Fujioka-shi, Gunma, Japan, 375-0015 | |
| Research Site | |
| Maebashi-shi, Gunma, Japan, 371-0022 | |
| Research Site | |
| Maebashi-shi, Gunma, Japan, 371-0046 | |
| Research Site | |
| Takasaki-shi, Gunma, Japan, 370-0829 | |
| Research Site | |
| Kawani-shi, Hyogo, Japan, 666-0125 | |
| Research Site | |
| Kobe-shi, Hyogo, Japan, 657-0068 | |
| Research Site | |
| Hitachi-shi, Ibaraki, Japan, 317-0077 | |
| Research Site | |
| Koga-shi, Ibaraki, Japan, 306-0041 | |
| Research Site | |
| Mito-shi, Ibaraki, Japan, 311-4198 | |
| Research Site | |
| Komatsu-shi, Ishikawa, Japan, 923-8560 | |
| Research Site | |
| Takamatsu-shi, Kagawa, Japan, 760-8557 | |
| Research Site | |
| Kochi-shi, Kochi, Japan, 781-8555 | |
| Research Site | |
| Kumamoto-shi, Kumamoto, Japan, 860-8556 | |
| Research Site | |
| Kyoto-shi, Kyoto, Japan, 615-8125 | |
| Research Site | |
| Kyoto-shi, Kyoto, Japan, 613-0911 | |
| Research Site | |
| Ina-shi, Nagano, Japan, 396-8555 | |
| Research Site | |
| Matsumoto-shi, Nagano, Japan, 390-0848 | |
| Research Site | |
| Suwa-shi, Nagano, Japan, 392-8510 | |
| Research Site | |
| Ibaraki-shi, Osaka, Japan, 567-0876 | |
| Research Site | |
| Suita-shi, Osaka, Japan, 565-0871 | |
| Research Site | |
| Toyonaka-shi, Osaka, Japan, 560-0082 | |
| Research Site | |
| Hanyu-shi, Saitama, Japan, 348-8505 | |
| Research Site | |
| Sayama-shi, Saitama, Japan, 350-1305 | |
| Research Site | |
| Toda-shi, Saitama, Japan, 335-0023 | |
| Research Site | |
| Otsu-shi, Shiga, Japan, 520-0113 | |
| Research Site | |
| Bunkyo-ku, Tokyo, Japan, 113-8519 | |
| Research Site | |
| Bunkyo-ku, Tokyo, Japan, 113-8421 | |
| Research Site | |
| Chiyoda-ku, Tokyo, Japan, 101-0041 | |
| Research Site | |
| Chuo-ku, Tokyo, Japan, 103-0027 | |
| Research Site | |
| Hachioji-shi, Tokyo, Japan, 192-0918 | |
| Research Site | |
| Itabashi-ku, Tokyo, Japan, 173-8610 | |
| Research Site | |
| Shinagawa-ku, Tokyo, Japan, 141-0001 | |
| Research Site | |
| Taito-ku, Tokyo, Japan, 111-0052 | |
| Research Site | |
| Toshima-ku, Tokyo, Japan, 171-0021 | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01652703 History of Changes |
| Other Study ID Numbers: | 20110231 |
| Study First Received: | July 26, 2012 |
| Last Updated: | April 1, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Amgen:
|
Japanese, hypercholesterolemia, high risk for cardiovascular events |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013