Unique ID issued by UMIN | UMIN000002964 |
---|---|
Receipt number | R000003436 |
Scientific Title | Prospective, randomized, open-label, clinical trial comparing fibrate monotherapy and fibrate-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties |
Date of disclosure of the study information | 2010/01/03 |
Last modified on | 2018/05/24 14:20:27 |
Prospective, randomized, open-label, clinical trial comparing fibrate monotherapy and fibrate-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties
Prospective, randomized, open-label, clinical trial comparing fibrate monotherapy and fibrate-ezetimibe combination therapy
Prospective, randomized, open-label, clinical trial comparing fibrate monotherapy and fibrate-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties
Prospective, randomized, open-label, clinical trial comparing fibrate monotherapy and fibrate-ezetimibe combination therapy
Japan |
dyslipidemia
Cardiology |
Others
NO
Comparison of fibrate monotherapy and fibrate-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties
Efficacy
Phase IV
Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization
Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization
Flow-mediated vasodilation in forearm, 6 months after randomization
Heparin-releasable EC-SOD levels, 6 months after randomization
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
No treatment
2
Treatment
Medicine |
Administration of ezetimibe
No medication
20 | years-old | < |
80 | years-old | > |
Male and Female
1) Dyslipidemic patients under treatment with fibrates, whose LDL-C levels do not meet those recommended by Japan Atherosclerosis Society Guidelines for prevention of Atherosclerotic Cardiovascular Disease.
2) Patients who have aortic atherosclerotic plaques detected by MRI
3) Outpatients
4) Subjects who gave written informed consent
1) Allergy against ezetimibe
2) Under treatment with statins
3) Poor-controlled hypertension (DBP>110 mmHg)
4) Poor-controlled diabetes (HbA1c>10.0 %)
5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
6) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits.
7) Chronic renal failure (serum creatinine>2.0 mg/dl)
8) Malignancies or other diseases with poor prognosis
9) Pregnant
10) Subjects whose doctor in charge do not agree to join the trial
60
1st name | |
Middle name | |
Last name | Katsunori Ikewaki |
National Defense Medical College
Department of Internal Medicine I
3-2 Namiki, Tokorozawa, JAPAN 359-8513
04-2995-1597
katsunorike@ndmc.ac.jp
1st name | |
Middle name | |
Last name | Makoto Ayaori |
National Defense Medical College
Department of Internal Medicine I
3-2 Namiki, Tokorozawa, JAPAN 359-8513
04-2995-1597
ayaori@ndmc.ac.jp
National Defense Medical College
Foundation for Promotion of Defense Medicine
Non profit foundation
Japan
NO
防衛医科大学校
2010 | Year | 01 | Month | 03 | Day |
Unpublished
Terminated
2009 | Year | 12 | Month | 20 | Day |
2010 | Year | 01 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2010 | Year | 01 | Month | 02 | Day |
2018 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003436
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |