UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006063 |
|---|---|
| Receipt number | R000007147 |
| Scientific Title | The effect of single tablet of fix-dose amlodipine and atorvastatin on blood pressure, lipid profile, and endothelium dependent relaxation of people with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2011/07/28 |
| Last modified on | 2012/08/29 15:02:19 |
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Basic information
Public title
The effect of single tablet of fix-dose amlodipine and atorvastatin on blood pressure, lipid profile, and endothelium dependent relaxation of people with type 2 diabetes mellitus
Acronym
The effect of single tablet of fix-dose amlodipine and atorvastatin on blood pressure, lipid profile, and endothelium dependent relaxation of people with type 2 diabetes mellitus
Scientific Title
The effect of single tablet of fix-dose amlodipine and atorvastatin on blood pressure, lipid profile, and endothelium dependent relaxation of people with type 2 diabetes mellitus
Scientific Title:Acronym
The effect of single tablet of fix-dose amlodipine and atorvastatin on blood pressure, lipid profile, and endothelium dependent relaxation of people with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
hypertension
dyslipidemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of single-pill amlodipin/atrovastatin of endothelium dependent relaxation, blood pressure and lipid profiles in people with type 2 diabetes treatmented by Ca blocker and statin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
the effect of single-pill amlodipin/atrovastatin upon FMD between baseline and after 3 months
Key secondary outcomes
Changes in the following items
blood pressure
lipid profiles (Total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglyceride, Malondialdehyde-modified low-density lipoprotein)
Fasting blood glucose, HbA1c, GA
Intima-Media Thickness (IMT)
eGFR, urinary albumin excretion
Questionnaire about medication adherance
Adverse effect
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 single-pill of fixed dose amlodipin (5mg) and atorvatatin (10mg)
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. people whose written imformed consent was obtained
2. people with type 2 diabetes mellitus complicated with hypertension and dyslipidemia
3. people were treated with amlodipin and any kind of statin except Atrovastatin for 3 months
Key exclusion criteria
1. the onset of ischemic heart disease (IHD) or stroke within 3 months
2. severe renal failure(Cr > 1.5mg/dl) and liver injury (AST and/or ALT > 100IU/dL)
3. pregnancy
4. Severe health problems not suitable for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Bando Hiroyuki |
Organization
FukuiKen Saiseikai Hospital
Division name
internal medicine
Zip code
Address
Funahashi Wadanaka 7-1, Fukui, Fukui, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
FukuiKen Saiseikai Hospital
Division name
internal medicine
Zip code
Address
Funahashi Wadanaka 7-1, Fukui, Fukui, Japan
TEL
0776231111
Homepage URL
shimaccyo@gmial.com
Sponsor or person
Institute
FukuiKen Saiseikai Hospital
Institute
Department
Personal name
Funding Source
Organization
no source of funding
Organization
Division
Category of Funding Organization
Other
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 | 07 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 28 | Day |
Last modified on
| 2012 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007147
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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