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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005916
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Cardiovascular Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006996

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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