UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002794 |
|---|---|
| Receipt number | R000003400 |
| Scientific Title | Effect of pitavastatin on increasing of high-density lipoprotein cholesterol and regression of carotid artery plaque. |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2010/05/25 13:18:11 |
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Basic information
Public title
Effect of pitavastatin on increasing of high-density lipoprotein cholesterol
and regression of carotid artery plaque.
Acronym
Effect of pitavastatin on increasing of high-density lipoprotein cholesterol
and regression of carotid artery plaque.
Scientific Title
Effect of pitavastatin on increasing of high-density lipoprotein cholesterol
and regression of carotid artery plaque.
Scientific Title:Acronym
Effect of pitavastatin on increasing of high-density lipoprotein cholesterol
and regression of carotid artery plaque.
Region
| Japan |
Condition
Condition
hypercholesterolemia
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Cardiology |
| Endocrinology and Metabolism | Geriatrics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of increasing of high-density lipoprotein cholesterol and the other factor on changing of carotid artery plaque.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between %change of high-density lipoprotein cholesterol and regression of carotid artery plaque.
Key secondary outcomes
1. Correlation between %change of LDL-C/ApoA1/hsCRP and regression of carotid artery plaque.
2. Incidence of major adverse cardiovascular events (MACE; defined as cardiac death, nonfatal myocardial infarction, unstable angina/cardiac failure/stroke / any other cardiac events required hospitalization).
3. Incidence of adverse effects.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
Oral administration of pitavastatin(2 mg/day) for a year. The dosage may be modulated according to the clinical parameters (pitavastatin 1 - 4 mg).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed as hypercholesterolemia based in Japan Atherosclerosis Society guidelines for prevention of atherosclerotic cardiovascular diseases.
Key exclusion criteria
1) HDL-C more than 100mg/dL.
2) Severe hypertensive patients.
3) History of cerebrovascular disease in 3 months before registration.
4) Severe renal dysfunction (creatinine>=2.0mg/dL)
5) Severe hepatic dysfunction.
6) Collagen disease.
7) Pregnant women, women suspected of being pregnant and lactating women or patients aiming to become pregnant during the clinical trial.
8) Without written informed consent.
9) Patients who are ineligible in the opinion of the investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Mukawa |
Organization
Ogaki Municipal Hospital
Division name
Department of Cardiology
Zip code
Address
4-86 minaminokawacho, Ogaki city,Gifu Prefectre
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ogaki Municipal Hospital
Division name
Department of Cardiology
Zip code
Address
4-86 minaminokawacho, Ogaki city,Gifu Prefectre
TEL
Homepage URL
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Chu-NET
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2009 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 24 | Day |
Last modified on
| 2010 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003400
