UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011005 |
|---|---|
| Receipt number | 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 15:08:16 |
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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
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
torimoto@med.uoeh-u.ac.jp
Sponsor or person
Institute
First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012861
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
