UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009169 |
|---|---|
| Receipt number | R000010743 |
| Scientific Title | Study of the effects by strong statins on the lipoprotein components and the renal function in patients with diabetes. - Study in the cases switched from Atorvastatin to Rosuvastatin- |
| Date of disclosure of the study information | 2012/10/25 |
| Last modified on | 2018/09/07 14:06:47 |
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Basic information
Public title
Study of the effects by strong statins on the lipoprotein components and the renal function in patients with diabetes.
- Study in the cases switched from Atorvastatin to Rosuvastatin-
Acronym
Effects of Rosuvastatin on the lipoprotein components and the renal function in patients with diabetes.
Scientific Title
Study of the effects by strong statins on the lipoprotein components and the renal function in patients with diabetes.
- Study in the cases switched from Atorvastatin to Rosuvastatin-
Scientific Title:Acronym
Effects of Rosuvastatin on the lipoprotein components and the renal function in patients with diabetes.
Region
| Japan |
Condition
Condition
Diabetes patients with dyslipidemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to elucidate whether the profiles of lipoprotein components such as IDL and s-LDL are improved by switching from Atorvastatin to Rosuvastation which has stronger potency of LDL-C lowering.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.The changes in s-LDL,IDL,LDL and HDL after switching.
2.Renoprotective effects of each statin(SCr,eGFR,Cystatin-C,Urinary albumin),HbA1c,CK,muscle spasms of the lower extremities.
Key secondary outcomes
1.The achievement ratio according to the management target level of LDL-C in JASGL2012
2.Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
5mg Rosuvastatin will be orally administered once daily for 12 months.
Interventions/Control_2
10mg Atorvastatin will be orally administered once daily for 12 months.
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 with diabetes
2) Patients who have been taking 10mg atorvastatin for more than 3 months
3) Patients whose HDL-C levels are less than 50mg/dL
4) Patiens who were recognized the existence of either s-LDL or IDL by Lipofo-AS kit.
5) Patients whose serum Cr levels less than or equql to 2.5mg/dL
6) Patients whose HbA1c levels(NGSP) are less than 10.4%.
Key exclusion criteria
1) Patients whose electrocardiograms at rest obviously showed the finding of myocardial ischemia.
2) Patients whose serum triglyceride levels are more than 400 mg/dL.
3) Patients whose HbA1c levels varied more than 2% within 3 months.
4) Patients who were judged as ineligible by investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Bando |
Organization
Saiseikai Fukui Hospital
Division name
internal medicine
Zip code
Address
7-1 Funahashi Wadanaka-cho,Fukui-city,Fukui
TEL
0776-23-1111
bando.yukihiro5002@fukui.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Bando |
Organization
Saiseikai Fukui Hospital
Division name
internal medicine
Zip code
Address
7-1 Funahashi Wadanaka-cho,Fukui-city,Fukui
TEL
0776-23-1111
Homepage URL
y-bando@fukui.saiseikai.or.jp
Sponsor or person
Institute
Fukui Saiseiki Hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
| 2012 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2012 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 15 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 23 | Day |
Last modified on
| 2018 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010743
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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