UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007297 |
|---|---|
| Receipt number | R000008180 |
| Scientific Title | Combination therapy with amlodipine or trichlormetiazide added irbesartan in hypertensive patients with diabetes |
| Date of disclosure of the study information | 2012/02/15 |
| Last modified on | 2012/02/15 11:37:43 |
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Basic information
Public title
Combination therapy with amlodipine or trichlormetiazide added irbesartan in hypertensive patients with diabetes
Acronym
Combination therapy with amlodipine or trichlormetiazide added irbesartan in hypertensive patients with diabetes
Scientific Title
Combination therapy with amlodipine or trichlormetiazide added irbesartan in hypertensive patients with diabetes
Scientific Title:Acronym
Combination therapy with amlodipine or trichlormetiazide added irbesartan in hypertensive patients with diabetes
Region
| Japan |
Condition
Condition
Hypertension with diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to analyze the effect of therapy with amlogipine or trichlormetiazide adeded irbesartan in hypertensive patients with diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
1.blood pressure
2.Renal function(urinaru albumin eGFR)
Key secondary outcomes
1.to evaluate the therapy if it could better responded to the patients with low or high sodium
2.PAC
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
combination with trichlormethiazide added irbesartan
Interventions/Control_2
combination with amlogdipine added irbesartan
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
1)20 years old
2)Hypertensive patients with diabetes
3)patient whose blood pressure did not reach the lebels reccomended by Hypertension Guidelines 2009 of Japanese Association,even when administered standard dose of irbesartan.
Key exclusion criteria
1)Hypersensitivity to or contraindication of irbesartan,trichlometiazide and amlodipine
2)within 3 months after onset of acute myocardial infarction
3)Symptomatic (NYHA3or4)congestive heart failure
4)Severe renal dysfunction or severe liver dysfunction
5)Pregnancy or its possibility
6) subjects whose doctor in charge do not agree to join the trial patients judged as inappropriate for the sutudy
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyu Takeda |
Organization
Kanazawa University Hospital
Division name
Internal Medicine
Zip code
Address
13-1 Takaramachi, Kanazawa city, Ishikawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Yoneda |
Organization
Kanazawa University Hospital
Division name
Internal Medicine
Zip code
Address
13-1 Takaramachi, Kanazawa city, Ishikawa, Japan
TEL
Homepage URL
Sponsor or person
Institute
Control of organ function, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
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
| 2012 | Year | 02 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 15 | Day |
Last modified on
| 2012 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008180
