UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005916 |
|---|---|
| Receipt number | R000006996 |
| Scientific Title | Investigation on the effect of sodium intake and anti-hypertensive therapy in the treatment Hypertension |
| Date of disclosure of the study information | 2011/07/04 |
| Last modified on | 2012/10/11 17:09:35 |
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Basic information
Public title
Investigation on the effect of sodium intake and anti-hypertensive therapy in the treatment Hypertension
Acronym
Valsartan-Tochigi Hypertension study UNDER monitoring of salt intake(Val-THUNDER)
Scientific Title
Investigation on the effect of sodium intake and anti-hypertensive therapy in the treatment Hypertension
Scientific Title:Acronym
Valsartan-Tochigi Hypertension study UNDER monitoring of salt intake(Val-THUNDER)
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate an additional hypotensive effect and safety profile of either ARB/CCB or ARB/Diuretics combination in the uncontrolled hypertensive patients treated with normal dose of ARB.
The study is also going to evaluate if the therapy could better respond to the Patients with low or high sodium intake to suggest better application of combined drug to the specific patient type.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Office BP
2)Change before and after treatment of the following items:Cr,K,Na,HbA1c,serum uric acid,Lipid
3)Adverse
Events:hyperuricemia,Hyponatremia,Edema
4)responder rate
Key secondary outcomes
1)Comparison of hypotensive effect by the level of sodium intake before drug administration
2)Comparison of responder rate by the level of sodium intake before drug administration
3)Change in urine albumin(before and after the treatment)
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
ARB/Diuretics combination
(Co-DIO combination tablets)
Interventions/Control_2
ARB/CCB
(DIOVAN 80 mg/amlodipine 5mg once a day or EXFORGE Combination tablets)
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)Hypertensive patients, who have been previously treated with monotherapy of an ARB for more than 4 weeks, however, whose blood pressure has not been reached the target defined by the JSH2009 criteria.
2)Patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to participate in the study
Key exclusion criteria
1)The age <20 years
2)Patients with secondary hypertension
3)-7)Contraindication of Valsartan and Hydrochlorothiazide
8)Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruo Inoue |
Organization
Dokkyo Medical University
Division name
Department of Cardiovascular Medicine
Zip code
Address
880 kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-86-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruo Inoue |
Organization
Dokkyo Medical University
Division name
Department of Cardiovascular Medicine
Zip code
Address
880 kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-86-1111
Homepage URL
Sponsor or person
Institute
Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2011 | Year | 07 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 04 | Day |
Last modified on
| 2012 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006996
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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