UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000812
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

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Basic information

Public title

A Study To verify the efficacy of ROsuvastatin 2.5 mg as an aggressive lipid lowering therapy for hypercholesterolemia-1

Acronym

ASTRO-1

Scientific Title

A Study To verify the efficacy of ROsuvastatin 2.5 mg as an aggressive lipid lowering therapy for hypercholesterolemia-1

Scientific Title:Acronym

ASTRO-1

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 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).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of decreases in serum LDL-C at week 8

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation

YES

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Rosuvastatin 2.5mg (1 tablet of rosuvastatin 2.5 mg tablet) will be orally administered once daily for 8 weeks.

Interventions/Control_2

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.

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 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

Key exclusion criteria

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

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsutomu Yamazaki

Organization

Graduate Scholl of Medicine, Faculty of Medicine, the University of Tokyo

Division name

Clinical Epidemiology and 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-1 study support center

Organization

Mebix Inc. ASTRO-1 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-1new@mebix.co.jp


Sponsor or person

Institute

Graduate Scholl of Medicine, the University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

None

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 08 Month 31 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

No longer recruiting

Date of protocol fixation

2007 Year 07 Month 31 Day

Date of IRB


Anticipated trial start date

2007 Year 09 Month 01 Day

Last follow-up date

2008 Year 03 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 08 Month 30 Day

Last modified on

2015 Year 05 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000972


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name