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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003168
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokushima Red Cross Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003842

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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