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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006605
Receipt No. R000007813
Scientific Title Randomized study to compare olmesartan + azelnidipine versus valsartan + amlodipine to maximize blood pressure control and organ protection
Date of disclosure of the study information 2011/10/24
Last modified on 2014/10/24

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Basic information
Public title Randomized study to compare olmesartan + azelnidipine versus valsartan + amlodipine to maximize blood pressure control and organ protection
Acronym The combination of olmesartan and azelnidipine in high-risk hypertensive patients
Scientific Title Randomized study to compare olmesartan + azelnidipine versus valsartan + amlodipine to maximize blood pressure control and organ protection
Scientific Title:Acronym The combination of olmesartan and azelnidipine in high-risk hypertensive patients
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of blood pressure control and organ protection between olmesartan/azelnidipine and valsartan/amlodipine combination therapy in hypertensive patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The efficacy of clinic and home blood pressure control
Key secondary outcomes CAVI(Cardio-Ankle Vascular Index)

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 YES
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 olmesartan + azelnidipine
Interventions/Control_2 valsartan + amlodipine
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 Essential hypertensive patients without receiving ARB administration and baseline BP is over 140/90 mmHg at least two BP measurements within 8 weeks.
Key exclusion criteria Patients were excluded from the study if there was any evidence of secondary hypertension, renal failure (serum creatinine&#8805;2.0mg/dl), severe liver dysfunction, symptomatic heart failure, and past history of cerebral infarction.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Matsubara Hiroaki
Organization Kyoto Prefectural University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL 075-251-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yamada Hiroyuki
Organization Kyoto Prefectural University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL 075-251-5511
Homepage URL
Email hiyamada@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University School of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University School of Medicine
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 10 Month 24 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 Terminated
Date of protocol fixation
2011 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 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
2011 Year 10 Month 24 Day
Last modified on
2014 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007813

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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