UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002202 |
|---|---|
| Receipt number | R000002706 |
| Scientific Title | Effect of Ezetimibe on Serum Remnant-Like Particle (RLP) Cholesterol in dyslipidemic patients with Diabetes Mellitus or the Metabolic Syndrome (EZREC Study) |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2009/07/15 00:30:45 |
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Basic information
Public title
Effect of Ezetimibe on Serum Remnant-Like Particle (RLP) Cholesterol in dyslipidemic patients with Diabetes Mellitus or the Metabolic Syndrome (EZREC Study)
Acronym
Effect of Ezetimibe on RLP- Cholesterol in dyslipidemic patients with DM or MetS (EZREC Study)
Scientific Title
Effect of Ezetimibe on Serum Remnant-Like Particle (RLP) Cholesterol in dyslipidemic patients with Diabetes Mellitus or the Metabolic Syndrome (EZREC Study)
Scientific Title:Acronym
Effect of Ezetimibe on RLP- Cholesterol in dyslipidemic patients with DM or MetS (EZREC Study)
Region
| Japan |
Condition
Condition
Hypercholesterolemia, Dyslipidemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of ezetimibe in dyslipidemic patients with DM or MetS on the serum levels of RLP- cholesterol, one of the distinct risk factors for cardiovascular complications
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Percent change of the serum levels of RLP- Cholesterol
Key secondary outcomes
Percent change of the serum levels of following parameters: total cholesterol (T-C), triglyceride, HDL-C, LDL-C, non-HDL-C, Apolipoproteins (A-I, A-II, B, C-II, C-III, E), ApoB/ApoA-I, small dense LDL, total adiponectin, high-sensitivity CRP, oxidized LDL, soluble LOX-1, Lp-PLA2, homocystein
2) Adverse Events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ezetimibe (10mg) daily, for 12 weeks
Interventions/Control_2
Diet therapy, for 12 weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria:
1. Patients with DM or MetS
2. Patients with not reaching target LDL-cholesterol (Japan Atherosclerosis Society Guideline 2007).
3. Over 20 years
4. Patients who provided written informed consent
Key exclusion criteria
1. Patients who had ischemic heart diseases
2. Patients who had stroke within the past 12 weeks
3. TG => 400 mg/dL
4. Familial Hypercholesterolemia
5. Patients with insulin treatment
6. Serious liver or renal diseases
7. Serious pulmonary disorder, and uncontrollable heart failure or arrhythmia
8. Patients who had taken probcol within the past 8 weeks
9. Patients who had been prescribed any other anti-hypercholesterol drugs within the past 4 weeks
10. Secondary dyslipidemia and drug induced dyslipidemia
11. Alcoholism, drug abuse or severe mental disorders
12. Patients who had severe anaphylactic reaction to ezetimibe or any other drug
13. During pregnancy or lactation
14. Other conditions precluding participation as judged by the investigator
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki YOKODE, MD, PhD |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Clinical Innovative Medicine
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku Kyoto 606-8507, Japan
TEL
075-751-4743
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu MINAMI, MD, PhD |
Organization
Kyoto University Hospital
Division name
Translational Research Center
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku Kyoto 606-8507, Japan
TEL
075-751-4739
Homepage URL
mminami@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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 | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | 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 | 07 | Month | 15 | Day |
Last modified on
| 2009 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002706
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