UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009169
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email y-bando@fukui.saiseikai.or.jp

Sponsor
Institute Fukui Saiseiki Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010743

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.