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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006796
Receipt No. R000008041
Scientific Title Standard versus intensive therApy by Rosuvastatin for lipiD lowering
Date of disclosure of the study information 2011/12/01
Last modified on 2014/06/04

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Basic information
Public title Standard versus intensive therApy by Rosuvastatin for lipiD lowering
Acronym SARD
Scientific Title Standard versus intensive therApy by Rosuvastatin for lipiD lowering
Scientific Title:Acronym SARD
Region
Japan

Condition
Condition Hyperlipemia
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For a hyperlipemic patient, examine the validity and safety of rosuvastatin high-dose medical treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes change of the inflammation marker at the time of registration and 12 weeks after. (Hs-CRP,RLP-cholesterol,MDA-LDL,small dense LDL,HMW-adioponectin,RAGE)
Key secondary outcomes The serum lipid improvement effect of 4 weeks and 12 weeks after.
(LDL-cholesterol,TG,HDL-cholesterol,
LDL/HDL ratio)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rosuvastatin high-dose medication group
Interventions/Control_2 Rosuvastatin low-dose medication group
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 he hyperlipemic subject who has not reached a lipid management target in the primary prevention (Category 3) or the secondary prevention patient set by the arteriosclerotic disease prevention guideline (2007)
Key exclusion criteria 1) Patients whom Rosuvastatin has already been prescribed
2) Familial hyperlipidemia or Secondary hyperlipemia
3) Patients with a history of hypersensitivity to statin
4) Patients who showed the symptoms of cerebrovascular disorder within 3months
5) Patients who showed the symptoms of myocardial infarction within 3 months
6) Patients diagnosed active liver disease(ALT or AST > 100 IU/L, T-bil > 2.5 mg/dL)
7) Patients with severe kidney dysfunction and also patients with poor control of kidney dysfunction
8)serum CK > 500 IU/L
9) Patients who are prescribing cyclosporin
10) Pregnant or lactating women
11) Decreased thyroid activity, A hereditary line disease(Muscular dystrophy etc) or patients with the family history, patients with the anamnesis of drug-induced muscle disorder
12) Drug abuse and/or patients of alcoholism
13)Patients who are considered not eligible for the study by the attending doctor due to other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Node
Organization Saga University Faculty of Medicine
Division name Department of Cardiovascular medicine
Zip code
Address 5-1-1 Nabeshima, Saga-shi, Saga
TEL 0952-34-2364
Email node@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Oyama
Organization Saga University Faculty of Medicine
Division name Department of Cardiovascular medicine
Zip code
Address 5-1-1 Nabeshima, Saga-shi, Saga
TEL 0952-34-2364
Homepage URL
Email junoyama@cc.saga-u.ac.jp

Sponsor
Institute Department of Cardiovascular medicine,
Saga University Faculty of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Edogawa Hospital
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 江戸川病院(東京都)、済生会唐津病院(佐賀県)、佐賀県立病院好生館(佐賀県)、佐賀大学病院(佐賀県)、伊万里有田共立病院(佐賀県)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2012 Year 12 Month 30 Day
Date of closure to data entry
2013 Year 02 Month 25 Day
Date trial data considered complete
2013 Year 03 Month 12 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 30 Day
Last modified on
2014 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008041

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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