UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000807 |
|---|---|
| Receipt number | R000000967 |
| Scientific Title | LIVES Study Extention |
| Date of disclosure of the study information | 2007/09/18 |
| Last modified on | 2011/11/08 15:40:20 |
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Basic information
Public title
LIVES Study Extention
Acronym
LIVES Study Extention
Scientific Title
LIVES Study Extention
Scientific Title:Acronym
LIVES Study Extention
Region
| Japan |
Condition
Condition
hypercholesterolemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preventive measure for incidence of cardiovascular and/or cerebrovascular diseases in Japanese who are taking Livalo (pitavastatin calcium)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Myocardial infarction, intervention due to angina, angina requiring hospitalization
2. Cerebral vascular events(infarction, hemorrhage, subarachnoid hemorrhage)
3. Sudden death
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been included in LIVES study
Key exclusion criteria
No written formed informed consent
Target sample size
7000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamio Teramoto |
Organization
Teikyo University School of Medicine
Division name
Internal Medicine
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Urashima |
Organization
Jikei University School of Medicine
Division name
Division of Molecular Epidemiology
Zip code
Address
TEL
0334331111
Homepage URL
urashima@jikei.ac.jp
Sponsor or person
Institute
LIVES Study Extension advisory committee
Institute
Department
Personal name
Funding Source
Organization
KOWA Co.Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
| 2007 | Year | 09 | Month | 18 | 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
Hypercholesterolemia patients were enrolled in the LIVALO Effectiveness and Safety Study (LIVES Study) and followed for 2 years while they were treated with pitavastatin at doses of 1, 2, or 4 mg/day. Cardiovascular events, cerebrovascular events, and sudden death during the pitavastatin-treatment period in these patients were studied. A total 6582 patients enrolled into the study. Pooled analysis of pitavastatin treatment, demonstrated LDL-C levels significantly decreased by 30.5%. The cumulative incidence of total cardiovascular events in the group achieving the LDL-C control goals was significantly lower than that in the group not achieving the goals. In addition, the cumulative incidence of total events in the group achieving the HDL-C control goal was significantly lower. These results indicate that it is essential to control both LDL-C and HDL-C at levels recommended as treatment goals in the relevant Guidelines for the suppression of the onset of cardiovascular and cerebrovascular events in patients with hypercholesterolemia during treatment with pitavastatin.
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
| 2007 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Prospective cohort study
Targetting patients who have been taking Livalo, we will follow-up these patients for 3 more years.
Management information
Registered date
| 2007 | Year | 08 | Month | 24 | Day |
Last modified on
| 2011 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000967
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
