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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002960
Receipt No. R000003352
Scientific Title Prospective, randomized, open-label, clinical trial comparing the effects of statin monotherapy and statin-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Date of disclosure of the study information 2010/01/03
Last modified on 2016/02/08

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Basic information
Public title Prospective, randomized, open-label, clinical trial comparing the effects of statin monotherapy and statin-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Acronym Prospective, randomized, open-label, clinical trial comparing statin monotherapy and statin-ezetimibe combination therapy
Scientific Title Prospective, randomized, open-label, clinical trial comparing the effects of statin monotherapy and statin-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Scientific Title:Acronym Prospective, randomized, open-label, clinical trial comparing statin monotherapy and statin-ezetimibe combination therapy
Region
Japan

Condition
Condition Coronary artery diseases
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of statin monotherapy (high dose) and statin (standard dose)-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization
Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization
Flow-mediated vasodilation in forearm, 6 months after randomization
Heparin-releasable EC-SOD levels, 6 months after randomization
Key secondary outcomes Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 statins alone
(high dose)
Interventions/Control_2 Administration of statins (standard dose)-ezetimibe as a combination
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 1) Patients with coronary artery diseases under administration of standard doses of statins, whose LDL-C are greater than 100 mg/dl
2) Patients who have aortic atherosclerotic plaques detected by MRI
3) Outpatients
4) Subjects who gave written informed consent
Key exclusion criteria 1) Allergy against statins and ezetimibe
2) Poor-controlled hypertension (DBP>110 mmHg)
3) Poor-controlled diabetes (HbA1c>10.0 %)
4) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
5) Either level of aspartate aminotransferase or alanine aminotransferase exceeds three-fold of the normal limits.
6) Chronic renal failure (serum creatinine>2.0 mg/dl)
7) Malignancies or other diseases with poor prognosis
8) Pregnant
9) Subjects whose doctor in charge do not agree to join the trial
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsunori Ikewaki
Organization National Defense Medical College
Division name Department of Internal Medicine I
Zip code
Address 3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL 04-2995-1597
Email katsunorike@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ayaori
Organization National Defense Medical College
Division name Department of Internal Medicine I
Zip code
Address 3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL 04-2995-1597
Homepage URL
Email ayaori@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Funding Source
Organization Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2010 Year 01 Month 03 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 No longer recruiting
Date of protocol fixation
2009 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2013 Year 10 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
2010 Year 01 Month 02 Day
Last modified on
2016 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003352

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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