UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004091 |
|---|---|
| Receipt number | R000004759 |
| Scientific Title | Effect of ezetimibe in hypercholesterolemic patient with glucose tolerance |
| Date of disclosure of the study information | 2010/08/24 |
| Last modified on | 2014/06/06 15:48:32 |
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Basic information
Public title
Effect of ezetimibe in hypercholesterolemic patient with glucose tolerance
Acronym
Effect of ezetimibe in hypercholesterolemic patient with glucose tolerance
Scientific Title
Effect of ezetimibe in hypercholesterolemic patient with glucose tolerance
Scientific Title:Acronym
Effect of ezetimibe in hypercholesterolemic patient with glucose tolerance
Region
| Japan |
Condition
Condition
Dyslipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of ezetimibe in hypercholesterolemic patient with glucose tolerance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of liipd levels(TC,TG,HDL-C,LDL-C,RLP-C)
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
After diet and exercise therapy for 12 weeks, ezetimibe(10mg) monotherapy,for 12 weeks
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
1)LDL-C>120mg/dL
Patients under drug therapy for dyslipidemia within 4 weeks.
2)glucose tolerance or type2 Diabetes(fasting plasma glucose>=110mg/dL or casual plasma glucos>=140mg/dL )
Key exclusion criteria
1)HbA1c>=9%
2)Patients with a history of hypersensitivity to any ingredient of ezetimibe tablets
3)Severe renal or hepatic disease
4)Having prior myocardial infarction or stroke
5)Patients with secondary hyperlipidemia or drug-associated hyperlipidemia
6)Patients who are pregnant or nursing mothers, patients who may be pregnant, or patients who want to become pregnant during participation in the study.
7)Familial hypercholesterolemia
8)Other patients deemed not appropriate for study entry by the investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinobu Satoh |
Organization
Chigasaki Municipal Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
5-15-1 Honson Chigasaki-shi Kanagawa, Japan
TEL
0467(52)1111
bleu-ciel@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Joe Nagakura |
Organization
Chigasaki Municipal Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
5-15-1 Honson Chigasaki-shi Kanagawa, Japan
TEL
0467(52)1111
Homepage URL
jo0806nagakura@hotmail.com
Sponsor or person
Institute
Chigasaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Chigasaki Municipal Hospital
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
茅ヶ崎市立病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 24 | 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
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 24 | Day |
Last modified on
| 2014 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004759
