UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002242 |
|---|---|
| Receipt number | R000002745 |
| Scientific Title | Comparison of Efonidipine/Irbesartan combination and Irbesartan monotherapy for uncontrolled hypertension |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2011/07/29 14:27:33 |
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Basic information
Public title
Comparison of Efonidipine/Irbesartan combination and Irbesartan monotherapy for uncontrolled hypertension
Acronym
Efonidipine and Irbesartan Therapy for Hypertension in Kyoto
Scientific Title
Comparison of Efonidipine/Irbesartan combination and Irbesartan monotherapy for uncontrolled hypertension
Scientific Title:Acronym
Efonidipine and Irbesartan Therapy for Hypertension in Kyoto
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of hypertension treatment is to prevent cardiovascular disease. However, not only blood pressure lowering but also organs protection effect is important for hypertension treatment. Because Irbesartan's effect on renal protection is established, it is possible to compare the effect of blood pressure lowering and organ protection using this drug. Although the guideline for the treatment of hypertension was released in 2009, it is still unclear whether we should use maximum dose of angiotensin 2 receptor antagonist (ARB) or ARB plus calcium antagonist to obtain better outcome.
In this study we compare the effect of usual dose of irbesartan/efonidipine combination and maximum dose of irbesartan treatment on blood pressure and albuminuria in uncontrolled hypertensive patients in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
blood pressure lowering after 1 month
Key secondary outcomes
1. blood pressure lowering after 6 months
2. Change in albuminuria after 6 months
3. adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
200mg Irbesartan od
Interventions/Control_2
100mg irbesartan + 40mg efonidipine od
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
uncontrolled hypertensive patients treated with anti-hypertensive drugs based on the guideline released from Japanese Society of Hypertension in 2009
Key exclusion criteria
1. pregnant patients
2. patients with severe liver dysfunction
3. patients with severe renal dysfunction
4. allergic to irbesartan or efonidipine
5. patients judged to be inappropriate for this study by attending physicians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Fujita |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Sciences
Zip code
Address
53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3932
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Arai |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Sciences
Zip code
Address
53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3861
Homepage URL
harai@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Coronary circulation funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kyoto University Hospital, Shiga University, Toyama University, Hiroshima University, Kobe City Medical Center General Hospital
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
| 2009 | Year | 09 | Month | 01 | 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 | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 23 | Day |
Last modified on
| 2011 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002745
