UMIN-CTR Clinical Trial

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

Patients with hypercholesterolemia

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Hakodate social gathering for atherosclerosis

Institute

Department

Personal name

Organization

Japan Heart Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2008

Year

11

Month

03

Day

Last modified on

2008

Year

11

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001795