UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000912 |
|---|---|
| Receipt number | R000001088 |
| Scientific Title | A Study To verify the efficacy of ROsuvastatin 5 mg as an aggressive lipid lowering therapy for hypercholesterolemia (No.2) |
| Date of disclosure of the study information | 2007/11/30 |
| Last modified on | 2009/12/03 18:59:09 |
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Basic information
Public title
A Study To verify the efficacy of ROsuvastatin 5 mg as an aggressive lipid lowering therapy for hypercholesterolemia (No.2)
Acronym
ASTRO-2
Scientific Title
A Study To verify the efficacy of ROsuvastatin 5 mg as an aggressive lipid lowering therapy for hypercholesterolemia (No.2)
Scientific Title:Acronym
ASTRO-2
Region
| Japan |
Condition
Condition
hypercholesterolemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare efficacy and safety of rosuvastatin and atorvastatin in patients who do not reach JAS guideline 2007 LDL-C goal.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage reduction from baseline in serum LDL-C at week 8
Key secondary outcomes
1) Percentage of patients who have reached JAS guideline 2007 LDL-C goal at week 8
2) Percentage change from baseline in serum lipids (HDL-C, TG, ApoB, ApoA-1, ApoB/ApoA-1 ratio, LDL-C/HDL-C ratio) at week 8
3) Percentage change from baseline in fasting blood glucose and HbA1c at week 8
4) Percentage change from baseline in serum lipids (HDL-C, LDL-C, TG, ApoB, ApoA-1, ApoB/ApoA-1 ratio, LDL-C/HDL-C ratio) at week 4
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rosuvastatin 5 mg (1 tablet of rosuvastatin 5 mg tablet or 2 tablets of rosuvastatin 2.5 mg tablet) will be orally administered once daily for 8 weeks.
Interventions/Control_2
Atorvastatin 10mg (1 tablet of atorvastatin 10 mg tablet or 2 tablets of atorvastatin 5 mg tablet) will be orally administered once daily for 8 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are not received statins, fibrates, cholesterol absorption inhibitors, or probucol therapy within past 2 months
2) Patients who do not reach JAS guideline 2007 LDL-C goal*
(* It is available to use the latest value measured under a fasting condition within 2 months of consent agreement. If no measured values are available, values calculated by Friedewald's formula [LDL- C = TC - HDL - C - TG/5] may be used.)
3) Patients who are able to submit written consent agreement by themselves
Key exclusion criteria
1) Patients with severe hypertension (SBP >= 180mmHg or DBP >= 110mmHg)
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 myocardial infarction or a cerebral stroke within 3 months
6) Patients with serious heart failure (NYHA class III to IV)
7) Patients who is scheduled to undergo 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/1.73m2)
10) Patients with CK > 1000 IU/L
11) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. Patients with history of drug-related muscular disorder
12) Patients with drug abuse or alcoholic
13) Pregnant women, impregnable women, or those who hope to be pregnant during the study period
14) Patients who use the prohibited concomitant drugs* or who might use such drugs during the study period
(* statins, fibrates, cholesterol absorption inhibitors, or probucol)
15) Patients who are ineligible in the opinion of the investigator
NB: For values of the tests mentioned above, it is available to use the latest value measured within 6 months of consent agreement.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Yamazaki |
Organization
Graduate School of Medicine, the University of Tokyo
Division name
Clinical Epidemiology & Systems
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL
03-5800-9844
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ASTRO-2 study support center |
Organization
Mebix Inc. ASTRO-2 Study Support Center Agency
Division name
Clinical Study Division
Zip code
Address
Koishikawadaikoku Bldg 2F, 1-3-25 Koishikawa, Bunkyo-ku, Tokyo, 112-0002, Japan
TEL
03-5842-3901
Homepage URL
Astro-2@mebix.co.jp
Sponsor or person
Institute
Graduate School of Medicine, the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 29 | Day |
Last modified on
| 2009 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001088
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