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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002673
Receipt No. R000003256
Scientific Title Prospective, randomized, open-label, clinical trial comparing standard and intensive LDL-lowering therapies using rosuvastatin on endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Date of disclosure of the study information 2010/10/28
Last modified on 2015/12/26

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Basic information
Public title Prospective, randomized, open-label, clinical trial comparing standard and intensive LDL-lowering therapies using rosuvastatin on endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Acronym Prospective, randomized, open-label, clinical trial comparing standard and intensive LDL-lowering therapies with rosuvastatin
Scientific Title Prospective, randomized, open-label, clinical trial comparing standard and intensive LDL-lowering therapies using rosuvastatin on endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Scientific Title:Acronym Prospective, randomized, open-label, clinical trial comparing standard and intensive LDL-lowering therapies with rosuvastatin
Region
Japan

Condition
Condition Hypercholesterolemia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of standard and intensive LDL-lowering therapies with rosuvastatin 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 Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6 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 months after randomization

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lowering LDL-cholesterol with rosuvastatin to minus 30%-levels which are recommended by Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases
Interventions/Control_2 Lowering LDL-cholesterol with rosuvastatin to the levels which are recommended by Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases
Interventions/Control_3 Diet therapy based on National Cholesterol Education Program-the third revision of the Adult Treatment Panel
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) Hypercholesterolemic patients recommended for administration of lipid-lowering agents in Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases
2) Outpatients
3) Subjects who gave written informed consent
Key exclusion criteria 1) Allergy against rosuvastatin
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 aminotransaminase 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 90

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Defense Medical College
Division name Department of Internal Medicine I
Zip code
Address
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

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 10 Month 28 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
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 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
2009 Year 10 Month 26 Day
Last modified on
2015 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003256

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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