UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000051501
Receipt number	R000058754
Scientific Title	A Clinical study in patients with dyslipidemia to determine the actual status of the percentage of patients achieving the target values for the management of LDL-Cholesterol specified in the Japan Atherosclerosis Society Guidelines for the Prevention of Atherosclerotic Cardiovascular Diseases (2022 edition)
Date of disclosure of the study information	2023/07/03
Last modified on	2023/07/07 16:29:31

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Basic information

Public title

A Clinical study in patients with dyslipidemia to determine the actual status of the percentage of patients achieving the target values for the management of LDL-Cholesterol specified in the Japan Atherosclerosis Society Guidelines for the Prevention of Atherosclerotic Cardiovascular Diseases (2022 edition)

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Dyslipidemia

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To understand the actual status of the percentage of patients achieving the target values for the management of LDL-Cholesterol specified in the Guidelines for the Prevention of Arteriosclerotic Disease (2022 edition) .

Basic objectives2

Others

Basic objectives -Others

determine the actual status

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Assessment

Primary outcomes

To understand the actual status of the percentage of patients achieving the target values for the management of LDL-Cholesterol

Key secondary outcomes

The impact of communicating their own target values for the management of LDL-Cholesterol to dyslipidemic patients on various lipid parameters(LDL-C,HDLC,Non-HDL-C,TG).

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

18 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Those who have given their free and voluntary written consent to participate in this study.
2)Men and women who are 18 years of age or older at the time consent is obtained.
3)Persons who have lipid abnormalities or have been diagnosed with dyslipidemia
4)Patients whose fasting blood collection measurements in Visit 1 (SCR) meet any of the following.
-LDL cholesterol 70 mg/dL or higher
-HDL cholesterol less than 40mg/dL
-TG 150 mg/dL or more, but less than 400 mg/dL
5)Patients who agree not to change the dosage and administration of the treatment for lipid disorders during the study period (V1 to V3).

Key exclusion criteria

1)Patients with malignant tumors within the past 10 years
2)Persons deemed ineligible by the study physician

Target sample size

180

Research contact person

Name of lead principal investigator

1st name Hirotaka

Middle name

Last name Nagashima

Organization

TOKYO CENTER CLINIC

Division name

Clinical Research Group

Zip code

1030028

Address

Yaesu KT Building 2F, 1-1-8, Yaesu, Chuo-ku, Tokyo

TEL

0332766935

Email

shimizu_satoko@tc-clinic.jp

Public contact

Name of contact person

1st name Hirotaka

Middle name

Last name Nagashima

Organization

TOKYO CENTER CLINIC

Division name

Clinical Research Group

Zip code

1030028

Address

Yaesu KT Building 2F, 1-1-8, Yaesu, Chuo-ku, Tokyo

TEL

0332766935

Homepage URL

Email

shimizu_satoko@tc-clinic.jp

Sponsor or person

Institute

TOKYO CENTER CLINIC

Institute

Department

Personal name

Funding Source

Organization

AstraZeneca K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Non Profit Organization Tokyo Allergy and Respiratory Disease Research Institute

Address

Riverside tower KURAMAE 3F, 1-8-6 Kuramae,Taito-ku,TOKYO

Tel

080-7360-0910

Email

info@inclusion-p.com

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京センタークリニック（東京都）

Other administrative information

Date of disclosure of the study information

2023 Year 07 Month 03 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

Open public recruiting

Date of protocol fixation

2023 Year 05 Month 22 Day

Date of IRB

2023 Year 05 Month 25 Day

Anticipated trial start date

2023 Year 07 Month 04 Day

Last follow-up date

2023 Year 10 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2023 Year 07 Month 02 Day

Last modified on

2023 Year 07 Month 07 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058754

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name