UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004924 |
|---|---|
| Receipt number | 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 17:30:06 |
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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
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
Sponsor or person
Institute
Department of Internal Medicine, School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005854
