UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001107 |
|---|---|
| Receipt number | R000001280 |
| Scientific Title | A Post-Marketing Clinical Study of Livalo Tablets: Evaluation of Effects on Yellow Plaques in the Coronary Arteries of Patients with Hypercholesterolemia |
| Date of disclosure of the study information | 2008/04/03 |
| Last modified on | 2011/11/16 16:41:08 |
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Basic information
Public title
A Post-Marketing Clinical Study of Livalo Tablets: Evaluation of Effects on Yellow Plaques in the Coronary Arteries of Patients with Hypercholesterolemia
Acronym
Stabilization and regression of coronary plaque treated with pitavastain proved by angioscopy and intravascular ultrasound (TOGETHAR)
Scientific Title
A Post-Marketing Clinical Study of Livalo Tablets: Evaluation of Effects on Yellow Plaques in the Coronary Arteries of Patients with Hypercholesterolemia
Scientific Title:Acronym
Stabilization and regression of coronary plaque treated with pitavastain proved by angioscopy and intravascular ultrasound (TOGETHAR)
Region
| Japan |
Condition
Condition
Hypercholesterolemia
Familial Hypercholesterolemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study is designed to identify factors determining the changes in yellow plaques in the coronary artery (as evaluated by angioscopy and intravascular ultrasonography) in patients with hypercholesterolemia accompanied by yellow coronary artery plaques following 52-week treatment with Livalo Tablets (2 mg/day).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Effects of the drug on changes in plaque color (assessed by angioscopy) and plaque volume and echo density (evaluated by intravascular ultrasonography)
Key secondary outcomes
Effects of the drug on changes in plaque color (assessed by angioscopy) and plaque volume and echo density (evaluated by intravascular ultrasonography)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A Livalo 2 mg tablet is orally administered once daily (after dinner).
Interventions/Control_2
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 study enrolls patients with hypercholesterolemia or familial hypercholesterolemia who satisfy all of the following requirements, are rated as indicated for Livalo Tablets and give their own consent to the study:
1) Age over 20 and less than 80 at the time of consent;
2) LDL-cholesterol level over 120 mg/dL within 4 weeks before the start of treatment with the test drug;
3) Individuals suspected of having coronary artery disease based on subjective symptoms (chest pain, etc.) and findings from various tests of the cardiovascular system or individuals rated as requiring coronary arteriography, angioscopy and intravascular ultrasonography for the purpose of follow-up of the previous interventions, etc.;
4) Individuals possessing at least one plaque in the coronary artery branches detectable by coronary arteriography* after acquisition of consent and rated at Grade 2-4 (excluding Grade 5) by angioscopy**;
*: Lesions having undergone or planned to undergo intervention are excluded from angioscopy.
**:Grade 0;not yellow, Grade 1; yellowish, Grade 2;yellow, Grade 3;deep yellow, Grade 4;brilliant yellow, Grade 5;thrombus
Key exclusion criteria
1) Patients currently receiving Livalo Tablets or having discontinued Livalo therapy before;
2) Patients absolutely or relatively contraindicated against Livalo Tablets;
3) Patients with hepatopathy or having ALT (GPT) or AST (GOT) level exceeding 2.5 times the upper limit of the criterion range;
4) Patients with compromised renal function (serum creatinine over 2.0 mg/dL);
5) Patients with a history of severe myopathy or CK (CPK) exceeding 2.5 times the upper limit of the criterion range;
6) Patients within 24 hours after onset of acute myocardial infarction;
7) Patients within 1 month after onset of cerebrovascular disease;
8) Patients with a history of malignant tumor or complicated by malignant tumors within 5 years before the start of treatment with the test drug;
9) Poorly controlled diabetic patients (HbA1C over 8.0%);
10) Patients receiving LDL apheresis;
11) Patients with the homozygote type of familial hypercholesterolemia;
12) Patients requiring treatment with the drugs whose concomitant use during this study is prohibited;
- Cyclosporine preparations
- Fibrates
- Nicotinic acid preparations
- HMG-CoA reductase inhibitors other than the test drug
- Cholestyramine
13)Drug addicts
14) Patients participating in some other clinical trials at present or having participated in other clinical trials completed within 4 months before;
15) Individuals judged as inappropriate for this post-marketing clinical study by the investigator or sub-investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Kodama |
Organization
Osaka Police Hospital
Division name
Cardiovascular Division
Zip code
Address
10-31, Kitayama-cho, Tennoji-ku Osaka, 543-0035, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Ueda |
Organization
Osaka Police Hospital
Division name
Cardiovascular Division
Zip code
Address
10-31, Kitayama-cho, Tennoji-ku Osaka, 543-0035, JAPAN
TEL
06-6771-6051
Homepage URL
ueda@oph.gr.jp
Sponsor or person
Institute
KOWA company, ltd.
Institute
Department
Personal name
Funding Source
Organization
KOWA company, ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 04 | Month | 03 | 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
Fixed dose pitavastatin treatment stabilized vulnerable coronary plaques as shown by the reduction of angioscopically-determined yellow grade, but it did not significantly reduce plaque volume measured by IVUS. These results suggest that the mechanisms underlying the stabilization and regression of atherosclerotic plaques by statin may differ from each other, but both nonetheless contribute to the reduction of cardiovascular events.
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
| 2004 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 02 | Day |
Last modified on
| 2011 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001280
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| Registered date | File name |
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| Registered date | File name |
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