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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001479
Receipt No. R000001795
Scientific Title The Hakodate multi-center pilot study of pitavastatin treatment on morphological changes of carotid atherosclerosis in patients with dyslipidemia
Date of disclosure of the study information 2008/11/10
Last modified on 2008/11/03

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Basic information
Public title The Hakodate multi-center pilot study of pitavastatin treatment on morphological changes of carotid atherosclerosis in patients with dyslipidemia
Acronym The Hakodate multi-center pilot study of pitavastatin treatment on carotid atherosclerosis in patients with dyslipidemia (HARMONY)
Scientific Title The Hakodate multi-center pilot study of pitavastatin treatment on morphological changes of carotid atherosclerosis in patients with dyslipidemia
Scientific Title:Acronym The Hakodate multi-center pilot study of pitavastatin treatment on carotid atherosclerosis in patients with dyslipidemia (HARMONY)
Region
Japan

Condition
Condition Patients with hypercholesterolemia
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the relations between morphology of carotid atherosclerosis and risks of the cardio- and cerebro- vascular events and effects of pitavastatin treatment on it.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of IMT and LINE obtained by carotid ultrasonography at the 12 to 24 months from the baseline.
Changes of PWV at the 12 to 24 months from the baseline.
Key secondary outcomes Co-relation between morphological change of carotid artery and change serum lipids or inflammatory markers.
Co-relation between Pulse Wave Velocity (PWV) and biomarkers.

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 pitavastatin treatment
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 satisfy all the inclusion criteria below.
1)Patients with hypercholesterolemia as defined by any of the following criteria.
1.LDL-C>=140 mg/dL
2.Cholesterol-lowering treatment is necessary in a accordance with the investigator's judgment when patient's LDL-C is between 100 to 140 mg/dL.
2)Patients 20 years or older
3)Male or Female
4)Outpatients
5)Patients giving written consent by their own volition after being provided sufficient explanation for participation in this trial.

Patients who satisfy all the inclusion criteria below.
1)Patients with hypercholesterolemia as defined by any of the following criteria.
1.LDL-C>=140 mg/dL
2.Cholesterol-lowering treatment is necessary in a accordance with the investigator's judgment when patient's LDL-C is between 100 to 140 mg/dL.
2) Patients 20 years or older
3) Male or Female
4) Outpatients
5) Patients giving written consent by their own volition after being provided sufficient explanation for participation in this trial.

Patients who satisfy all the inclusion criteria below.
Key exclusion criteria 1) Patients who meet contraindication or warning of LIVALO below(1-5).
1.Patients who have hypersensitivity to any component of this medicine.
2. Patients who have severe liver dysfunction or biliary atresia.
3. Patients receiving cyclosporine
4. Patients who are or might be pregnant or are in lactation period.
5. Patients taking fibrates with any abnormalities in clinical data about kidney function.
2) Patients already taking LIVALO.
3) 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 Jun Niwa
Organization Hakodate Municipal Hospital
Division name Department of Neurosurgery
Zip code
Address 1-10-1 Minato-cho, Hakodate, Hokkaido, 041-0821
TEL 0138-43-2000
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigeo Nakajima
Organization Nakajima Internal medicine, circulatory system and mental Clini
Division name Internal medicine and circulatory system
Zip code
Address 19-13 Omori-cho, Hakodate, Hokkaido, 040-0034
TEL 0138-22-4347
Homepage URL
Email shigshig@gmail.com

Sponsor
Institute Hakodate social gathering for atherosclerosis
Institute
Department

Funding Source
Organization Japan Heart Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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 11 Month 10 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 Preinitiation
Date of protocol fixation
2008 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2013 Year 10 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
2008 Year 11 Month 03 Day
Last modified on
2008 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001795

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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