UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002698
Receipt number R000003290
Scientific Title Open-labeled randomized parallel trial to compare the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of standard atorvastatin administration.
Date of disclosure of the study information 2009/11/02
Last modified on 2017/10/22 17:15:29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Open-labeled randomized parallel trial to compare the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of standard atorvastatin administration.

Acronym

Comparison of the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of atorvastatin administration.

Scientific Title

Open-labeled randomized parallel trial to compare the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of standard atorvastatin administration.

Scientific Title:Acronym

Comparison of the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of atorvastatin administration.

Region

Japan


Condition

Condition

coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of atorvastatin administration.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of LDL-C

Key secondary outcomes

1) Changes of RLP-C, hs-CRP, lipid peroxidation, Non HDL-C, Non HDL-C/HDL-C, LDL-C/HDL-C, TC, TG, HDL-C.
2) Change of insulin resistance.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients who have more than 100mg/dL of LDL-C in spite of taking atorvastatin 10mg/day will be additionally administered another 10mg/day of atorvastatin for 6 months.

Interventions/Control_2

Patients who have more than 100mg/dL of LDL-C in spite of taking atorvastatin 10mg/day will be additionally administered ezetimib 10mg/day for 6 months.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who have a history of myocardial infarction or angina pectoris diagnosed by coronary angiography, or have more than 25% stenosis in coronary artery assessed by MDCT.
2) Patients who meet a criteria for metabolic syndrome (NCEP-ATP3 2004 with some modifications)
3) Patients who have more than 100mg/dL of LDL-C in spite of taking atorvastatin 10mg/day for at least 3 month.

Key exclusion criteria

1) Patients with more than 500mg/dL of triglyceride.
2) Patients with hepatic dysfunction [ALT>3 x upper limit of normal range.]
3) Patients with renal dysfunction [Serum creatinine >2 x upper limit of normal range]
4) Patients with a history of myocardial infarction, unstable angina, CABG operation or stroke within recent 3 months.
5) Patients with uncontrolled diabetes mellitus (HbA1c>9%).
6) Patients with a history of drug-allergy (shock, anaphylaxis, vascular edema).
7) Patients taking immune-suppressor.
8) Patients with familial hypercholesterolemia.
9) Patients with secondary hyperlipidemia.
10) Alcohol abusers.
11) Patients with drug-induced hyperlipidemia (steroid, or other medicine)
12) Pregnant or possibly pregnant women. Those who want or are wanted by the partner to be pregnant.
13) Patients hypersensitive with this medicine and /or contaminants of this medicine.
14) Patients who are judged to be inappropriate as a subject by a doctor.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Morihiro Matsuda

Organization

National Hospital Organization, Kure Medical Center and Chugoku Cancer Center

Division name

Department of Cardiology

Zip code


Address

3-1 Aoyamacho, Kure, Hiroshima

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Morihiro Matsuda

Organization

National Hospital Organization, Kure Medical Center and Chugoku Cancer Center

Division name

Department of Cardiology

Zip code


Address


TEL


Homepage URL


Email

morihiro-m@kure-nh.go.jp


Sponsor or person

Institute

National Hospital Organization, Kure Medical Center and Chugoku Cancer Center

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

独立行政法人国立病院機構呉医療センター・中国がんセンター(広島県)


Other administrative information

Date of disclosure of the study information

2009 Year 11 Month 02 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

Terminated

Date of protocol fixation

2009 Year 06 Month 12 Day

Date of IRB


Anticipated trial start date

2009 Year 11 Month 01 Day

Last follow-up date

2010 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 01 Day

Last modified on

2017 Year 10 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003290


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name