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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002207
Receipt No. R000002713
Scientific Title Blood pressure lowering effect of combination therapy of angiotensin receptor blocker (ARB) and Ca antagonist in patients with high risk hypertension
Date of disclosure of the study information 2009/07/22
Last modified on 2009/07/15

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Basic information
Public title Blood pressure lowering effect of combination therapy of angiotensin receptor blocker (ARB) and Ca antagonist in patients with high risk hypertension
Acronym Therapeutic efficacy of combination therapy of angiotensin receptor blocker (ARB) and Ca antagonist to patients with high risk hypertension
Scientific Title Blood pressure lowering effect of combination therapy of angiotensin receptor blocker (ARB) and Ca antagonist in patients with high risk hypertension
Scientific Title:Acronym Therapeutic efficacy of combination therapy of angiotensin receptor blocker (ARB) and Ca antagonist to patients with high risk hypertension
Region
Japan

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

Objectives
Narrative objectives1 To compare the blood lowering efficacy between olmesartan medoxomil plus azelnidipine administration and valsartan plus amlodipine besilate administration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Blood lowering effect and percentage of the attainment of therapeutic goal three and six months after treatment
Key secondary outcomes Chenges of various biomarker six months after treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Combination of olmesartan medoxomil 20mg/day and azelnidipine 16mg/day
Interventions/Control_2 Combination of valsartan 80mg/day and amlodipine besilate 5mg/day
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
85 years-old >
Gender Male and Female
Key inclusion criteria Hypertensive patients categolized into
high risk group
Key exclusion criteria 1. Patients with hypersensitive history to olmesartan medoxomil, azelnidipine, valsartan and amlodipine besilate
2. Pregnant women or women who have possibility of pregnancy
3. Patients administrated with azole antifungal drug or protease inhibitor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka Sata
Organization Institute of Health Biosciences, The University of Tokushima Graduate School
Division name Department of Cardiovascular Medicine
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-7851
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Iwase
Organization Institute of Health Biosciences, The University of Tokushima Graduate School
Division name Department of Cardiovascular Medicine
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-7851
Homepage URL
Email tiwase@clin.med.tokushima-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Institute of Health Biosciences, The University of Tokushima Graduate School
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Institute of Health Biosciences, The University of Tokushima Graduate School
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
2009 Year 07 Month 22 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 Preinitiation
Date of protocol fixation
2009 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 02 Month 01 Day
Date trial data considered complete
2013 Year 02 Month 01 Day
Date analysis concluded
2013 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 15 Day
Last modified on
2009 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002713

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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