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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000912
Receipt No. 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

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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
Email

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
Email Astro-2@mebix.co.jp

Sponsor
Institute Graduate School of Medicine, the University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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