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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001107
Receipt No. 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

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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
Email

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
Email ueda@oph.gr.jp

Sponsor
Institute KOWA company, ltd.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001280

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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