UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007225 |
|---|---|
| Receipt number | R000008510 |
| Scientific Title | The study to investigate effects of ezetimibe on the changes in plasma incretins |
| Date of disclosure of the study information | 2012/02/06 |
| Last modified on | 2013/08/04 09:59:40 |
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Basic information
Public title
The study to investigate effects of ezetimibe on the changes in plasma incretins
Acronym
The study to investigate effects of ezetimibe on the changes in plasma incretins
Scientific Title
The study to investigate effects of ezetimibe on the changes in plasma incretins
Scientific Title:Acronym
The study to investigate effects of ezetimibe on the changes in plasma incretins
Region
| Japan |
Condition
Condition
dyslipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of ezetimibe (intesitinal cholesterol transporter inhibitor) on the changes in plasma incretins in patients with hypercholesterolemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The effects of ezetimibe on the changes in plasma incretins during meal tolerance test
Key secondary outcomes
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 10 mg/day
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
LDL cholesterol >= 140 mg/dl with and without statin use
Key exclusion criteria
1. hypersensitivity to ezetimibe
2. patients with insulin, arufa-glucosidase inhibitor, biguanide or thiazolidinedione
3. patients with severe hepatic disease
4. patients with severe renal dysfunction
5. secondary hypercholesterolemia
6. familiar hypercholesterolemia
7. patients who are judged as inappropriate for this study by physicians
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuma Narita |
Organization
Akita University Graduate School of Medicine
Division name
Department of Endocrinology, Diabetes and Geriatric Medicine
Zip code
Address
Hondo 1-1-1, Akita, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma Narita |
Organization
Akita University Graduate School of Medicine
Division name
Department of Endocrinology, Diabetes and Geriatric Medicine
Zip code
Address
Hodo 1-1-1, Akita, Japan
TEL
Homepage URL
narita@med.akita-u.ac.jp
Sponsor or person
Institute
Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No applicable
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
| 2012 | Year | 02 | Month | 06 | 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
| 2011 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 04 | Day |
Last modified on
| 2013 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008510
