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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010895
Receipt No. R000012749
Scientific Title The study for the efficacy of amlodipine/atorvastatin combination drug in patients with type 2 diabetes complicated with hypertention and hypercholestrolemia.
Date of disclosure of the study information 2013/06/08
Last modified on 2016/03/08

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Basic information
Public title The study for the efficacy of amlodipine/atorvastatin combination drug in patients with type 2 diabetes complicated with hypertention and hypercholestrolemia.
Acronym Caduet clinical research
Scientific Title The study for the efficacy of amlodipine/atorvastatin combination drug in patients with type 2 diabetes complicated with hypertention and hypercholestrolemia.
Scientific Title:Acronym Caduet clinical research
Region
Japan

Condition
Condition Type 2 diabetes complicated with hypertention and hypercholestrolemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigatethe efficasy of amlodipine/atorvastatin combination drug in patients eith type 2 diabetes complicated with hypertentions and hypercholesterolemia,and which patients receive the treatment for hypertension with amolodipine besilate and do not achieve the lipid management goals,regardless with or without medication for hypercholesterolemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)The amount of change in serum LDL-C levels between at baseline and after 6 months.
2)The amount of change in systolic blood pressure between at baseline and after 6 months.
Key secondary outcomes 1)The amount of change in serum LDL-C levels between at baseline and after 12 months.
2)The amount of change in systolic blood pressure between at baseline and after 12 months.
3)Achievement rate of lipid management goal of after 6 and 12 months.
4)The amount of change in the follwing items between at the baseline and 6 months or 12 months.
Diastolic blood pressure.
8-iso-PGF2 concentration in blood
The amount of change in oxidized LDL
Fasting blood glucose level
The amount of change in HbA1c
Cystatin-C concentration
Urinary albumin / creatinine ratio
eGFR
Blood adiponectin concentration
5)The amount of change in carotid IMT between at baseline and 6 or 12 months.
6)Adverse events.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Switching to amlodipine / atorvastatin combination drug.
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 1) Outpatient
2) Patients receiving the treatment with amlodipine besilate for more than 3 months,at the time of registration.
3) Patients whose serum LDL-C levels are more than 120mg/dl,regardless with or without medication for hypercholesterolemia,at the time of registration.
4) Patients who can obtain voluntary conset documents for participation in this study,after a sufficient informed consent.
Key exclusion criteria 1) Patients whose systolic blood pressure is more than 180mmHg and diastolic blood pressure is more than 110mmHg and whose blood pressure are not well-controlled and considered to add or increase the dose of hypertensive drugs druing this study.
2) Secondry hypertention patiebs.
3) Familial hypercholesterolemia patients.
4) Patients with secondary prevention who developed cardiovascular events,such as acute myocardial infarction and cerebral infarction in the past.
5) Patients with severe heart failure patients.
6) Patients with severe arrhythmias.
7) eGFR is less than 40ml/min/1.73 square meters.
8) Patients with advanced liver failure.
9) Patients with active malignancy.
10)Patients during administration of immunosuppressants or steroid.
11) Women who are pregnant or possibly pregnant or wish to pregnant or lactating.
12)Patients with allergy or contraindication to test drug.
13) Intellectually or mentally disabled patients who are impossible to agree or with suspected ability to agree.
14) Patients judged not suitable by the attending physician.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Koya
Organization Kanazawa Medical University
Division name Diabetes and Endocrinology
Zip code
Address Daigaku1-1 Uchinadamachi Kahokugun Ishikawaken
TEL 076-286-2211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Munehiro Kitada
Organization Kanazawa Medical University
Division name Diabetes and Endocrinology
Zip code
Address Daigaku1-1 Uchinadamachi Kahokugun Ishikawaken
TEL 076-286-2211
Homepage URL
Email

Sponsor
Institute Kanazawa Medical University
Diabetes and Endocrinology
Institute
Department

Funding Source
Organization Kanazawa Medical University
Diabetes and Endocrinology
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 08 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
2013 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 08 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 07 Day
Last modified on
2016 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012749

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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