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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002593
Receipt No. R000003155
Scientific Title Recognized Effect of Statin and Ezetimibe therapy for achievement LDL-C Goal
Date of disclosure of the study information 2009/10/07
Last modified on 2015/03/30

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Basic information
Public title Recognized Effect of Statin and Ezetimibe therapy for achievement LDL-C Goal
Acronym RESEARCH
Scientific Title Recognized Effect of Statin and Ezetimibe therapy for achievement LDL-C Goal
Scientific Title:Acronym RESEARCH
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the eficacy of ezetimibe 10mg administered with statin in Japanese patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Percent reduction in LDL-C from baseline to study endpoint.
Key secondary outcomes Percentage of patients who reached the treatment goals (LDL-C 120mg/dl or 100mg/dl).
Percent change of serum lipids, serum markers of glucose metabolism and serum markers of inflammation.

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 Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 atorvastatin 10mg and ezetimibe 10mg/
atorvastatin 20mg
Interventions/Control_2 pitavastatin 1mg and ezetimibe 10mg/
pitavastatin 2mg
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 (1) Type 2 diabetes.
(2) Serum LDL-C over 120mg/dL after administration of atorvastatin 10mg or pitavastatin 1mg for one month or more.
Key exclusion criteria (1) History of hypersensitivity to atorvastatin, pitavastatin or ezetimibe
(2) Serum triglyceride level more than 400mg/dl
(3) Hepatic dysfunction (an alanine aminotransferase level that is more than twice the upper limit of the normal range)
(4) Uncontrolled diabetes (HbA1c more than 9.0%)
(5) Renal dysfunction (a creatinine level that is higher than 2.0 mg per deciliter)
(6) Secondary or drug-induced hypercholesterolemia
(7) Homozygous familial hypercholesterolemia
(8) Pregnant or nursing women or women suspect of pregnancy
(9) Judged as inappropriate for study by doctor
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruo Shiba
Organization Mitsui Memorial Hospital
Division name Department of internal medicine/Division of diabetes and metabolism
Zip code
Address 1 Kandaizumicho, Chiyoda-ku, Tokyo 101-8643, JAPAN
TEL +81-3-3862-9111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Mitsui Memorial Hospital
Division name Department of internal medicine/Division of diabetes and metabolism
Zip code
Address
TEL
Homepage URL
Email isogawa-tky@umin.ac.jp

Sponsor
Institute Clinical study group for diabetes and dyslipidemia
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

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 07 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 Main results already published
Date of protocol fixation
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 06 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 10 Month 07 Day
Last modified on
2015 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003155

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2015/04/01 RESEARCH_dataset.xlsx


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