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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002698
Receipt No. 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

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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
Institute National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Institute
Department

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
URL(English) https://upload.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


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