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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000480
Receipt No. R000000580
Scientific Title The randomized controlled trial about the regression of atherosclerosis by using pioglitazone added to statin treatment
Date of disclosure of the study information 2006/09/26
Last modified on 2008/08/26

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Basic information
Public title The randomized controlled trial about the regression of atherosclerosis by using pioglitazone added to statin treatment
Acronym Research about the regression of atherosclerosis by pioglitazone therapy
Scientific Title The randomized controlled trial about the regression of atherosclerosis by using pioglitazone added to statin treatment
Scientific Title:Acronym Research about the regression of atherosclerosis by pioglitazone therapy
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is examined whether the pioglitazone therapy added to statin treatment in the coronary artery disease patient brings about regression of atherosclerosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes carotid intima-media thickness by carotid artery echo
if possible, coronary angiography and intravascular ultrasound
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is 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 15 to 45mg pioglitazone is administered for the patient for six months once per day added to statin therapy
Interventions/Control_2 statin therapy only
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 The non-diabetic patients who have 50% or more of stenosis in coronary artery, and their serum LDL levels were controlled less than 100mg/dl under the statin treatment.
Key exclusion criteria anamnesis of cardiac insufficiency
LVEF<40%
critical hepatopathy(an increase the twice as many fiducial point of AST,ALT, ALP,etc, and choloplania)
renal dysfunction(more than serum creatine 2.0mg/dl)
anaphylactic anamnesis to piogritazon
critical trauma, preoperative, serious infectious desease, pregnancy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Ogawa
Organization Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Division name cardiovascular medicine
Zip code
Address 1-1-1 Honjo, Kumamoto City, Kumamoto, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kumamoto University hospital
Division name cardiovascular medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization none
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
2006 Year 09 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

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
2005 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2007 Year 04 Month 01 Day
Date of closure to data entry
2008 Year 04 Month 01 Day
Date trial data considered complete
2008 Year 04 Month 01 Day
Date analysis concluded
2008 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 08 Month 31 Day
Last modified on
2008 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000580

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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