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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002261
Receipt No. 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

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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
Email 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
Email node@cc.saga-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Saga University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002759

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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