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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006063
Receipt No. 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

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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
Email

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
Email shimaccyo@gmial.com

Sponsor
Institute FukuiKen Saiseikai Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007147

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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