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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004924
Receipt No. R000005854
Scientific Title The effect of single tablet of fixed-dose amlodipine and atorvastatin on blood pressure, lipid profile, and oxidative stress of the patients with type 2 diabetes mellitus
Date of disclosure of the study information 2011/01/24
Last modified on 2013/01/21

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Basic information
Public title The effect of single tablet of fixed-dose amlodipine and atorvastatin on blood pressure, lipid profile, and oxidative stress of the patients with type 2 diabetes mellitus
Acronym The effect of single tablet of fixed-dose amlodipine and atorvastatin on blood pressure, lipid profile, and oxidative stress of the patients with type 2 diabetes mellitus
Scientific Title The effect of single tablet of fixed-dose amlodipine and atorvastatin on blood pressure, lipid profile, and oxidative stress of the patients with type 2 diabetes mellitus
Scientific Title:Acronym The effect of single tablet of fixed-dose amlodipine and atorvastatin on blood pressure, lipid profile, and oxidative stress of the patients with type 2 diabetes mellitus
Region
Japan

Condition
Condition type 2 diabetes mellitus
hypertension
dyslipidemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Both amlodipine and atorvastatin have been reported to reduce oxidative stress. Evidnce that both drugs are effective for preventing cardiovascular and cerebrovascular events has been accumulated. Therefore, we perform a clinical investigation using single tablet of fixed dose of amlodipine (5 mg) and atorvastatin (10 mg). This trial evaluates the effect of this medicine on the MDA-LDL cholesterol, which is an indicator of oxidative stress, prospectively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The blood pressure-lowering effect, the lipid profile-improving effect, and the effect to the MDA-LDL cholestreol of single tablet of fixed dose of amlodipine (5 mg) and atorvastatin (10 mg)
Key secondary outcomes eGFR, urinary albumin excretion
Intima-Media Thickness
Pulse Wave Velocity
Questionnaire about medication adherance

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 administration of sigle tablet of fixed dose amlodipin (5 mg) and atorvatatin (10 mg)
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
80 years-old >
Gender Male and Female
Key inclusion criteria (1)patients whose written imformed consent was obtained
(2)patients with type 2 diabetes mellitus complicated with hypertension and hyper LDL-cholesterolemia
(3)patients who do not achieve the target designated in the Japanese Atherosclerosis society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007.
Key exclusion criteria (1)mild to severe renal dysfunction(CKD stage 3 or more advanced, diabetic nephropathy 3B or more advanced)
(2)allergy to amlodipine or atorvastatin
(3)liver dysfunciton (acute hepatitis, acute deterioration of chronic hepatitis, liver cirhosis, hepatic cell carcinoma, jaundice)
(4)(possible) pregnant woman, breast- feeding woman
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tanaka Masami
Organization School of Medicine, Keio University
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization School of Medicine, Keio University
Division name 35 Shinanomachi, Shinjuku-ku, Tokyo
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Internal Medicine, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Self funding
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
2011 Year 01 Month 24 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 11 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2012 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 21 Day
Last modified on
2013 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005854

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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