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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014372
Receipt No. R000016726
Scientific Title The difference of combination therapy in uncontrolled hypertension
Date of disclosure of the study information 2014/07/01
Last modified on 2017/05/30

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Basic information
Public title The difference of combination therapy in uncontrolled hypertension
Acronym The difference of combination therapy in uncontrolled hypertension
Scientific Title The difference of combination therapy in uncontrolled hypertension
Scientific Title:Acronym The difference of combination therapy in uncontrolled hypertension
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the difference in blood pressure control and some indices between the combination angiotensin receptor blocker (ARB) with calcium blocker and the combination ARB with diuretics in uncontrolled hypertension
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes -change in blood pressure at home blood pressure measurement
-change in augmentation index
Key secondary outcomes -change in blood pressure (BP) at 24hr BP monitoring and clinic BP
-change in NTproBNP, hsCRP, hsTnT, cystatin C, VEGF-C, LDL cholesterol, triglyceride, HDL cholesterol, BUN, creatinine, potassium, sodium, glucose, urine-sodium, and urinary albumin creatinine ratio

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
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 One group taken the combination ARB with diuretics (Ecard HD(R))
Interventions/Control_2 One group taken the combination ARB with diuretics (Unisia HD(R))
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 Patients with diagnosed hypertension in our hospital and collaborate research institutes.
(Inclusion criteria)
1)Patients taken each calcium blocker or ARB, or patients with alfa blocker or beta blocker adding in each calcium blocker or ARB.
2)In spite of performing life modification (diet and exercise) and the above medication, their clinic BP is above 140/90mmHg.
Key exclusion criteria (Exclusion criteria)
1)Allergy of these drugs in this study
2)Anuria or hemodialysis
3)Acute renal failure
4)Significant low sodium and potassium
5)Pregnancy or possibility of pregnancy
6)Not given informed consent (adolescents, dementia)
7)In case the physicians decide to be inappropriate in this study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL 0285-58-7538
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Hoshide
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL 0285-58-7344
Homepage URL
Email hoshide@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization Jichi Medical University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 鷲谷病院(栃木県)(Washiya hospital)
国際医療福祉大学病院(栃木県)(International university of health and welfare hospital)
古河赤十字病院(茨城県)(Koga red cross hospital)

Other administrative information
Date of disclosure of the study information
2014 Year 07 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
2011 Year 03 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 25 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
2014 Year 06 Month 25 Day
Last modified on
2017 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016726

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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