UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003168 |
|---|---|
| Receipt number | R000003842 |
| Scientific Title | Clinical research on concurrent therapy of Ezetimibe and Statin |
| Date of disclosure of the study information | 2010/02/12 |
| Last modified on | 2010/02/11 13:35:58 |
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Basic information
Public title
Clinical research on concurrent therapy of Ezetimibe and Statin
Acronym
Absorption control Concurrent Therapy study(ACT study)
Scientific Title
Clinical research on concurrent therapy of Ezetimibe and Statin
Scientific Title:Acronym
Absorption control Concurrent Therapy study(ACT study)
Region
| Japan |
Condition
Condition
Coronary artery disease or diabetic
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness and the safety of the concurrent therapy of Ezetimibe and Statin in coronary artery disease and the diabetic.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Change of LDL-C
Key secondary outcomes
1)Accomplishment rate of less than LDL-C100mg/dL and accomplishment rate of less than LDL-C70mg/dL in patient with coronary artery disease.
Or, the accomplishment rate of less than LDL-C value 120mg/dL in the diabetic.
2)Decreasing of hs-CRP.
3)Accomplishment rate of less than LDL-C70mg and less than hs-CRP0.2mg/dL in coronary artery disease person.
4)Change of HDL-C, LDL-C/HDL-C, nonHDL-C.
5)Electrocardiogram(improvement level of ST-T, ventricular rate, left ventricular hypertrophy (SV1+RV5)).
6)Change of kidney function(s-Cr, eGFR).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Coronary artery disease patients who have more than 100mg/dL of LDL-C in spite of taking statin will be additionally administered ezetimib 10mg/day for 6~9 months.
Interventions/Control_2
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
Coronary artery disease patients who have more than 100mg/dL of LDL-C in spite of taking statin for at least 3 month.
Or, diabetic patients who have more than 120mg/dL of LDL-C in spite of taking statin for at least 3 month.
Key exclusion criteria
(1)Patient that there is previous history of hypersensitivity in experimental drug or Statin
(2)TG 400mg/dL or more
(When the measurement of LDL-C is only a calculation method)
(3)Patients with hepatic dysfunction (ALT>3 x upper limit of normal range)
(4)Patients with renal dysfunction (Serum creatinine >2 x upper limit of normal range)
(5)Patient of 9% or more in HbA1c
(6)Patient of 1% or more in change of HbA1c
(7)Patients with secondary hyperlipidemia or medicinal hyperlipemia
(8)Patients with a history of CABG operation or stroke within recent 3 months
(9)Pregnant or possibly pregnant women
(10)Patients who are judged to be inappropriate as a subject by a doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Hiasa |
Organization
Tokushima Red Cross Hospital
Division name
Division of cardiology
Zip code
Address
103 Azairinokuchi,komatsushimacho,Komatsushima,Tokushima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKAFUMI NAKAGAWA |
Organization
Tokushima Red Cross Hospital
Division name
Division of cardiology
Zip code
Address
103 Azairinokuchi,komatsushimacho,Komatsushima,Tokushima
TEL
Homepage URL
Sponsor or person
Institute
Tokushima Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation,Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2010 | Year | 02 | Month | 12 | 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
| 2009 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | 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
| 2010 | Year | 02 | Month | 11 | Day |
Last modified on
| 2010 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003842
| Research Plan | |
|---|---|
| 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 |
