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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005078
Receipt No. R000006031
Scientific Title The effects of ezetimibe on malondialdehyde-modified low-density lipoprotein in abnormal glucose tolerance patients with coronary artery disease
Date of disclosure of the study information 2011/02/15
Last modified on 2011/02/14

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Basic information
Public title The effects of ezetimibe on malondialdehyde-modified low-density lipoprotein in abnormal glucose tolerance patients with coronary artery disease
Acronym The effects of ezetimibe on MDA-LDL in abnormal glucose tolerance patients with coronary artery disease
Scientific Title The effects of ezetimibe on malondialdehyde-modified low-density lipoprotein in abnormal glucose tolerance patients with coronary artery disease
Scientific Title:Acronym The effects of ezetimibe on MDA-LDL in abnormal glucose tolerance patients with coronary artery disease
Region
Japan

Condition
Condition Coronaty artery disease with diabetes, including impaired glucose torelance
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Oxidised low-density lipoprotein cholesterol (ox-LDL) is a new marker that was shown to better predict cardiovascular risk than standard lipid parameters.
Ezetimibe and statins were shown in few studies to reduce atherogenic ox-LDL cholesterol beyond LDL cholesterol lowering, and no clinical trial has been performed to investigate the differential effects among the drugs.
The aim of this study is to examine the differential effects on blood sugar and plasma lipid, including malondialdehyde-modified LDL, among ezetimibe and atorvastatin in abnormal glucose tolerance patients with coronary artery disease utilizing cross-over design.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change and percent change in MDA-LDL
Key secondary outcomes Change and percent change in TC, LDL-C, TG, and HDL-C.
Change and percent change in HbA1c

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of atorvastatin 20mg in the first 3 months, followed by the administration of atorvastatin 10mg and ezetimibe 10mg
Interventions/Control_2 Administration of atorvastatin 10mg and ezetimibe 10mg in the first 3 months, followed by the administration of atorvastatin 20mg
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) Patients who have a history of following coronary heart diseases;
CABG or PCI was performed more than 6 months before
>= 50% coronary artery stenosis according to the ACC/AHA classification was found by CAG
2) Diabetic patients under treatment or patients who diagnosed with diabetic (inclucing IGT; 2-hour plasma/serum glucose level: 140mg/dL to 199mg/dL) at 75g oral glucose tolerance test
3) Patients who take atorvastatin 10mg more than 3 months
4) Patients who are judged to require the more lipid-lowering therapy
Key exclusion criteria 1) Patients with history of acute coronary syndrome within 6 months
2) Patients with inflammatory disease, infectious disease, and malignancy
3) Patients with history of hypersensitivity against ezetimibe and atorvastatin
4) Pregnant women, women who may be pregnant, and breast-feeding women.
5) Patients with severe liver dysfunction or renal dysfunction
6) Insulin-treated diabetic patients
7) Patients judged by the investigator/ sub investigator to be ineligible for some other reason
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Watarai
Organization Cardiovascular Center, Anjo Kosei Hospital
Division name Division of Cardiology
Zip code
Address 28 Higashi-hirokute, Anjo-cho, Anjo-city, Aichi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Cardiovascular Center, Anjo Kosei Hospital
Division name Division of Cardiology
Zip code
Address 28 Higashi-hirokute, Anjo-cho, Anjo-city, Aichi
TEL
Homepage URL
Email

Sponsor
Institute Cardiovascular Center, Anjo Kosei Hospital
Institute
Department

Funding Source
Organization self funding
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
2011 Year 02 Month 15 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
2008 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 01 Month 01 Day
Date analysis concluded
2011 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 14 Day
Last modified on
2011 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006031

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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