Unique ID issued by UMIN | UMIN000000812 |
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Receipt number | R000000972 |
Scientific Title | A Study To verify the efficacy of ROsuvastatin 2.5 mg as an aggressive lipid lowering therapy for hypercholesterolemia-1 |
Date of disclosure of the study information | 2007/08/31 |
Last modified on | 2015/05/26 18:35:39 |
A Study To verify the efficacy of ROsuvastatin 2.5 mg as an aggressive lipid lowering therapy for hypercholesterolemia-1
ASTRO-1
A Study To verify the efficacy of ROsuvastatin 2.5 mg as an aggressive lipid lowering therapy for hypercholesterolemia-1
ASTRO-1
Japan |
Hypercholesterolemia
Cardiology | Endocrinology and Metabolism |
Others
NO
To compare efficacy and safety of rosuvastatin and pravastatin in patients with serum LDL-C lower than the target value for primary prevention of onset of coronary artery diseases classified by Japan Atherosclerosis Society Guidelines for prevention of atherosclerotic cardiovascular diseases 2007 (JAS-GL2007).
Safety,Efficacy
Confirmatory
Rate of decreases in serum LDL-C at week 8
1) Ratio of patients who have reached the target serum LDL-C value specified in JASGL2007 at week 8.
2) Rates of changes in serum lipid parameter (HDL-C, TG, ApoB, ApoA-1, ApoB/ApoA-1 ratio, LDL-C/HDL-C ratio) at week 8.
3) Rates of changes in fasting blood glucose and HbA1c at week 8.
4) Rates of changes in serum lipid parameter (HDL-C, LDL-C, TG, ApoB, ApoA-1, ApoB/ApoA-1 ratio, LDL-C/HDL-C ratio) at week 4
Interventional
Parallel
Randomized
Open -no one is blinded
Active
YES
NO
Central registration
2
Treatment
Medicine |
Rosuvastatin 2.5mg (1 tablet of rosuvastatin 2.5 mg tablet) will be orally administered once daily for 8 weeks.
Pravastatin 10 mg (1 tablet of pravastatin 10 mg tablet or 2 tablets of pravastatin 5 mg tablet) will be orally administered once daily for 8 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients who are not received statin therapy within past 2 months at the time of submitting written consent agreement
2) Patients with serum LDL-C lower than the target value specified in JAS-GL2007 who have LDL-C<180 mg/dL and are not complicated with or history of coronary artery diseases (*use the latest value measured under a fasting condition within 6 months of consent agreement. If no measured values are available, values calculated by Friedewald's formula may be used.)
3) Patients who are able to submit written consent agreement by themselves
1) Patients with Severe hypertension (SBP>=180 mmHg or DBP>=110 mmHg)
2) Patients with type I diabetes
3) Patients with familial hypercholesterolemia
4) Patients with fasting serum
TG>=400 mg/dL
5) Patients who have experienced cerebrovascular diseases within 3 months
6) Patients with serious heart failure (NYHA class III to IV)
7) Patients undergoing PTCA/CABG during the study period
8) Patients with active hepatic disease (ALT or AST>100 IU/L or total bilirubin> 2.5 mg/dL)
9) Patients with renal disorder
(Cr>=2.0 mg/dL or Ccr<30 mL/min/1.73 m2)
10) Patients with CK>1000 IU/L
11) Pregnant women, impregnable women, or those who hope to be pregnant during the study period
12) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. Patients with history of drug-related muscular disorder
13) Patients with drug abuse or alcoholism
14) Patients who use prohibited concomitant drugs* or who might use such drugs during the study period
15) Patients who are ineligible in the opinion of the investigator
*Statines, fibrates, anion exchange resin,
cholesterol absorption inhibitors, probucol, nicotine acids, phytosterol, other anti hypercholesterolaemia drugs, immune suppressing drugs
100
1st name | |
Middle name | |
Last name | Tsutomu Yamazaki |
Graduate Scholl of Medicine, Faculty of Medicine, the University of Tokyo
Clinical Epidemiology and Systems
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
03-5800-9844
1st name | |
Middle name | |
Last name | ASTRO-1 study support center |
Mebix Inc. ASTRO-1 study support center agency
Clinical study division
Koishikawadaikoku Bldg 2F, 1-3-25 Koishikawa, Bunkyo-ku, Tokyo, 112-0002, Japan
03-5842-3901
astro-1new@mebix.co.jp
Graduate Scholl of Medicine, the University of Tokyo
None
Non profit foundation
None
NO
2007 | Year | 08 | Month | 31 | Day |
Unpublished
No longer recruiting
2007 | Year | 07 | Month | 31 | Day |
2007 | Year | 09 | Month | 01 | Day |
2008 | Year | 03 | Month | 01 | Day |
2007 | Year | 08 | Month | 30 | Day |
2015 | Year | 05 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000972
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