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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002794
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Ogaki Municipal Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003400

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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