UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003458 |
|---|---|
| Receipt number | R000004183 |
| Scientific Title | effect of antihypertensive combination therapy with either CCB or diuretics on irbesartan on hypertensive patient with metabolic syndrome:A randomised controlled trial |
| Date of disclosure of the study information | 2010/04/07 |
| Last modified on | 2014/08/14 16:51:12 |
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Basic information
Public title
effect of antihypertensive combination therapy with either CCB or diuretics on irbesartan on hypertensive patient with metabolic syndrome:A randomised controlled trial
Acronym
effect of antihypertensive combination therapy
Scientific Title
effect of antihypertensive combination therapy with either CCB or diuretics on irbesartan on hypertensive patient with metabolic syndrome:A randomised controlled trial
Scientific Title:Acronym
effect of antihypertensive combination therapy
Region
| Japan |
Condition
Condition
hypertensive patient with metabolic syndorome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effect of antihypertensive combination therapy with either CCB or diuretics on irbesartan on hypertensive patient with metabolic syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
degree and accomplishment of a BP recommended goal
Key secondary outcomes
clinical parameters
fasting glucose levels
HOMA-R
TG
HDL-C
LDL-C
u-albumin:creatinine ratio
e-GFR
ICAM-1
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
irbesartan(50-200mg)+amlodipine(2.5-10mg)/day
Interventions/Control_2
irbesartan(50-200mg)+indapamide(0.5-2mg)/day
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
hypertennsive patients with metabolic syndrome
1)Hypertention
ARB other than irbesartan have been administered for one month or more.
The home blood pressure value is SBP125mmHg or DBP75mmHg and above the value of the blood pressure of the examination room is SBP130mmHg or DBP80mmHg or more.
2)Patient who fill metabolic syndrome criteria standard
Key exclusion criteria
1)Hypersensitivity
2)Pregnant woman or possibility of pregnancy
3)Diuretic and CCB are administered
4)Steroid or the immunosuppressive agent is taken
5)Patient who judged that doctor in charge is improper
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Koya |
Organization
Kanazawa Medical University
Division name
Diabetes & Endocrinology
Zip code
Address
Daigaku1-1 Uchinadamachi Kahokugun Ishikawaken
TEL
076-286-2211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Koya |
Organization
Kanazawa Medical University
Division name
Diabetes & Endocrinology
Zip code
Address
Daigaku1-1 Uchinadamachi Kahokugun Ishikawaken
TEL
076-286-2211
Homepage URL
koya0516@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Diabetes & Endocrinology
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
Diabetes & 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
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
| 2010 | Year | 04 | Month | 07 | 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
| 2009 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 07 | Day |
Last modified on
| 2014 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004183
