UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000480 |
|---|---|
| Receipt number | 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 09:48:44 |
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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
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
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000580
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
