Unique ID issued by UMIN | UMIN000011745 |
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Receipt number | R000013737 |
Scientific Title | Prospective, randomized, open-label, clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe on progression of atherosclerotic plaques and endothelial function |
Date of disclosure of the study information | 2013/09/14 |
Last modified on | 2016/01/02 16:53:00 |
Prospective, randomized, open-label, clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe on progression of atherosclerotic plaques and endothelial function
Clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe
Prospective, randomized, open-label, clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe on progression of atherosclerotic plaques and endothelial function
Clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe
Japan |
Dyslipidemia
Cardiology | Endocrinology and Metabolism |
Others
NO
To compare rosuvastatin monotherapy and rosuvastatin-ezetimibe combination therapy on atherosclerotic plaques progression and endothelial function
Efficacy
(1) Carotid atherosclerosis evaluated by ultrasound (Intima-media thickness; IMT (meanIMT/maxIMT) and plaque score)
12/24 months after randomization
(2) Area and thickness of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI)
12/24 months after randomization
(3) Flow-mediated vasodilation in forearm
6 months after randomization
(1) Ankle/brachial index and cardio ankle vascular index
(2) Markers for diabetes (hemoglobin A1c, glycoalbumin, blood glucose)
(3) Serum lipids
(4) Markers indicating obesity (e.g. adiponectin)
(5) Markers indicating inflammation (e.g. high sensitive CRP)
(6) Markers indicating oxidative stress (8-OHdG/ MDA-LDL)
(7) Markers indicating chronic renal diseases (urine albumin/L-FABP)
(8) Blood/urine urate levels
(9) Body weight/waist circumference
(10) Blood pressures
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Rosuvastatin monotherapy
(titrate the dosage to achieve LDL-C target levels 30% lower than those recommended by the clinical guideline in Japan)
Rosuvastatin/ezetimibe combination therapy
(titrate the dosage of rosuvastatin to achieve LDL-C target levels 30% lower than those recommended by the clinical guideline in Japan)
20 | years-old | <= |
80 | years-old | > |
Male and Female
) Dyslipidemic patients whose LDL-C levels did not reach those recommended by Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases
2) Patients who have aortic atherosclerotic plaques detected by MRI
3) Outpatients
4) Subjects who gave written informed consent
1) Allergy against rosuvastatin or ezetimibe
2) Poor-controlled diabetes (HbA1c>10.0 %)
3) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
4) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits.
5) End stage renal disease
6) Symptomatic (NYHA III or IV) congestive heart failure
7) Malignancies or other diseases with poor prognosis
8) Pregnant
9) Subjects whose doctor in charge do not agree to join the trial
66
1st name | |
Middle name | |
Last name | Katsunori Ikewaki |
National Defense Medical College
Department of Internal Medicine
3-2 Namiki, Tokorozawa, JAPAN 359-8513
04-2995-1617
katsunorike@ndmc.ac.jp
1st name | |
Middle name | |
Last name | Makoto Ayaori |
National Defense Medical College
Department of Internal Medicine
3-2 Namiki, Tokorozawa, JAPAN 359-8513
04-2995-1617
ayaori@ndmc.ac.jp
National Defense Medical College
Foundation for Promotion of Defense Medicine
Non profit foundation
NO
2013 | Year | 09 | Month | 14 | Day |
Unpublished
Completed
2013 | Year | 08 | Month | 30 | Day |
2013 | Year | 09 | Month | 14 | Day |
2013 | Year | 09 | Month | 13 | Day |
2016 | Year | 01 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013737
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