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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011005
Receipt No. R000012861
Scientific Title Ezetimibe 10 mg + rosuvastatin 2.5 mg versus rosuvastatin 5 mg for hypercholesterolemia in patients with type 2 diabetes
Date of disclosure of the study information 2013/06/20
Last modified on 2013/06/19

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Basic information
Public title Ezetimibe 10 mg + rosuvastatin 2.5 mg versus rosuvastatin 5 mg for hypercholesterolemia in patients with type 2 diabetes
Acronym Ezetimibe 10 mg + rosuvastatin 2.5 mg versus rosuvastatin 5 mg for hypercholesterolemia in patients with type 2 diabetes
Scientific Title Ezetimibe 10 mg + rosuvastatin 2.5 mg versus rosuvastatin 5 mg for hypercholesterolemia in patients with type 2 diabetes
Scientific Title:Acronym Ezetimibe 10 mg + rosuvastatin 2.5 mg versus rosuvastatin 5 mg for hypercholesterolemia in patients with type 2 diabetes
Region
Japan

Condition
Condition Hypercholesterolemic patients with type 2 diabetes.
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In patients with type 2 diabetes who are already being treated with statins, it remains unclear whether it is more effective to add ezetimibe or to increase the statin dose. Therefore, this study is performed to examine the effects of these two regimens on LDL-C and lipoproteins.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint is set as the percent change of LDL-C after 12 weeks compared with baseline.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The add-on ezetimibe group (combined group) that received 2.5 mg/day of rosuvastatin and 10 mg/day of ezetimibe.
Interventions/Control_2 The rosuvastatin dose escalation group that received 5 mg/day of rosuvastatin.
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
80 years-old >
Gender Male and Female
Key inclusion criteria The subjects of this study are hypercholesterolemic patients with type 2 diabetes aged from 20 years to less than 80 years, who have been receiving rosuvastatin (2.5 mg/day) for more than 12 weeks but have LDL-C levels higher than 80 mg/dL, whose therapeutic regimen has not been changed for the past three months, and who have an HbA1c (NGSP) of less than 8.4%.
Key exclusion criteria Patients with a history of familial hypercholesterolemia, patients who have developed stroke or ischemic heart disease within the past six months, patients with liver failure (ALT and/or AST >80 IU/L) or kidney failure (serum creatinine >1.3 mg/dL), patients using insulin, patients who are pregnant or could possibly become pregnant, and patients who are breast feeding are excluded from the study.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiya Tanaka
Organization School of Medicine, University of Occupational and Environmental Health
Division name First Department of Internal Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushyu-shi, 807-8555, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization School of Medicine, University of Occupational and Environmental Health
Division name First Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email torimoto@med.uoeh-u.ac.jp

Sponsor
Institute First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
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
2013 Year 06 Month 20 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 Completed
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 19 Day
Last modified on
2013 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012861

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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