UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001472 |
|---|---|
| Receipt number | R000001790 |
| Scientific Title | Clinical Trials for Effectiveness of Combination Therapy using Ezetimive and Rosuvastatin/Atorvastatin |
| Date of disclosure of the study information | 2008/11/01 |
| Last modified on | 2009/11/11 17:37:20 |
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Basic information
Public title
Clinical Trials for Effectiveness of Combination Therapy using Ezetimive and Rosuvastatin/Atorvastatin
Acronym
CTE2RA
Scientific Title
Clinical Trials for Effectiveness of Combination Therapy using Ezetimive and Rosuvastatin/Atorvastatin
Scientific Title:Acronym
CTE2RA
Region
| Japan |
Condition
Condition
IHD subjects who are taking rosvastatin 2.5mg or atorvastatin 10mg more than 3 months and whose LDL-C is > 100mg/dl.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparisons between combination therapy (ezetimibe and statins) and statin alone therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, cholesterol absorption marker, cholesterol synthesis marker, glucose metabolic marker, inflammation marker, other laboratory findings.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Combination therapy wiht ezetimibe 10mg
Interventions/Control_2
Increase in dose for both statins.
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
Subjects who has a past history of coronary heart diseases with LDL-C >100mg/dl and who took rosuvastatin 2.5mg or atorvastatin 10mg more than 3 months. Age from 20 to 80. Gender free.
Key exclusion criteria
1)Subjects with hypersentivity for ezetimibe or staitns.
2)triglyceride>500mg/dl
3)liver dysfunction (AST>twice as much as the upperlimit of the facilities.
4)kidney dysfunction (serum Cr>2.0mg/dl)
5)secondary hyperlipidemia or drug induced hyperlipidemia
6)unstabel angina, myocardial infarction, coronary bypass surgery, brain infarction within 3 months.
7)pregnancy, lactation, possible pregnancy
8)According to the attending physician`s judgements
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Iwahashi |
Organization
Yokohama City University Center Hospital
Division name
Department of Cardiology
Zip code
Address
Urafune, Minami, Yokohama
TEL
045-261-5656
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuaki Uchino |
Organization
Department of Medicine and Cardio-renal Medicine
Division name
Department of Medicine and Cardio-renal Medicine
Zip code
Address
TEL
Homepage URL
tommmish@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine, Department of Medicine and Cardio-renal Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Center Hospital
Department of Cardiology
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
| 2008 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | 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
| 2008 | Year | 11 | Month | 01 | Day |
Last modified on
| 2009 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001790
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
