UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002261 |
|---|---|
| Receipt number | R000002759 |
| Scientific Title | Evaluation of combination therapy with Statin and Ezetimible for patients with type II diabetes. |
| Date of disclosure of the study information | 2009/07/28 |
| Last modified on | 2016/01/28 10:20:47 |
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Basic information
Public title
Evaluation of combination therapy with Statin and Ezetimible for patients with type II diabetes.
Acronym
Evaluation of combination therapy with Statin and Ezetimible
Scientific Title
Evaluation of combination therapy with Statin and Ezetimible for patients with type II diabetes.
Scientific Title:Acronym
Evaluation of combination therapy with Statin and Ezetimible
Region
| Japan |
Condition
Condition
Pateients with type II diabetes combined with dyslipidemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of effect of combination therapy with Statin and Ezetimible for patients with type II diabetes and dyslipidemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Examination of the rate change of glucouse metabolism and inflammatory marker
Examination of ameliorating effect in kidney function
Key secondary outcomes
Examination of the rate change of TC, HDL cholesterol, and TG
Decreasing rate of LDL cholesterol
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ezetimibe and Statin
Interventions/Control_2
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
For entry into the study, participants must meet all of the following criteria.
1) Type II diabetes
2) Dyslipidemia given statin drug over 3 months.
3) At the time of entry, ezetimibe is not taken.
4) Age: 20years or older
5) Gender: regardless
6) Outpatient/hospitalized: regardless
7) Agreements: capable of giving consent and written agreement.
Key exclusion criteria
1) Pregnant and/or breathfeeding, child-bearing potential women during this study.
2) Past history of severe allergic reactions to ezetimibe
3) Renal dysfunctioned. (ALT>2 x Normal range of each institute)
4) Uncontrolled diabetes mellitus (HbA1c>=9%)
5) Renal insufficiency (serum creatinine>2.0mg/dL)
6) Heart failure, cardiac infarct, unstable angina, or stroke whithin 3 months.
7) Recieving insulin therapy
8) Secondary hyperlipidemia and/or drug-induced hyperlipidemia
9) Familial hyperlipidemia
10) otherwise, treating physician judged not to be appropriate for inclusion in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Node, MD, PhD |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
Address
5-1-1, Nabeshima, Saga city, Saga
TEL
0952-34-2364
node@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Node, MD, PhD |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2364
Homepage URL
node@cc.saga-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Saga University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Saga University
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 07 | Month | 28 | 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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 28 | Day |
Last modified on
| 2016 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002759
