UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002593 |
|---|---|
| Receipt number | R000003155 |
| Scientific Title | Recognized Effect of Statin and Ezetimibe therapy for achievement LDL-C Goal |
| Date of disclosure of the study information | 2009/10/07 |
| Last modified on | 2015/03/30 19:39:07 |
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Basic information
Public title
Recognized Effect of Statin and Ezetimibe therapy for achievement LDL-C Goal
Acronym
RESEARCH
Scientific Title
Recognized Effect of Statin and Ezetimibe therapy for achievement LDL-C Goal
Scientific Title:Acronym
RESEARCH
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the eficacy of ezetimibe 10mg administered with statin in Japanese patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percent reduction in LDL-C from baseline to study endpoint.
Key secondary outcomes
Percentage of patients who reached the treatment goals (LDL-C 120mg/dl or 100mg/dl).
Percent change of serum lipids, serum markers of glucose metabolism and serum markers of inflammation.
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
atorvastatin 10mg and ezetimibe 10mg/
atorvastatin 20mg
Interventions/Control_2
pitavastatin 1mg and ezetimibe 10mg/
pitavastatin 2mg
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) Type 2 diabetes.
(2) Serum LDL-C over 120mg/dL after administration of atorvastatin 10mg or pitavastatin 1mg for one month or more.
Key exclusion criteria
(1) History of hypersensitivity to atorvastatin, pitavastatin or ezetimibe
(2) Serum triglyceride level more than 400mg/dl
(3) Hepatic dysfunction (an alanine aminotransferase level that is more than twice the upper limit of the normal range)
(4) Uncontrolled diabetes (HbA1c more than 9.0%)
(5) Renal dysfunction (a creatinine level that is higher than 2.0 mg per deciliter)
(6) Secondary or drug-induced hypercholesterolemia
(7) Homozygous familial hypercholesterolemia
(8) Pregnant or nursing women or women suspect of pregnancy
(9) Judged as inappropriate for study by doctor
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruo Shiba |
Organization
Mitsui Memorial Hospital
Division name
Department of internal medicine/Division of diabetes and metabolism
Zip code
Address
1 Kandaizumicho, Chiyoda-ku, Tokyo 101-8643, JAPAN
TEL
+81-3-3862-9111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Mitsui Memorial Hospital
Division name
Department of internal medicine/Division of diabetes and metabolism
Zip code
Address
TEL
Homepage URL
isogawa-tky@umin.ac.jp
Sponsor or person
Institute
Clinical study group for diabetes and dyslipidemia
Institute
Department
Personal name
Funding Source
Organization
none
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 | 10 | Month | 07 | 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
Main results already published
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | 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 | 10 | Month | 07 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003155
