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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002242
Receipt No. 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

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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
Email

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
Email harai@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002745

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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