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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003238
Receipt No. R000003921
Scientific Title Evaluation of Olmesartan on the Control of Morning Blood Pressure
Date of disclosure of the study information 2010/02/28
Last modified on 2014/01/29

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Basic information
Public title Evaluation of Olmesartan on the Control of Morning Blood Pressure
Acronym Evaluation of Olmesartan on the Control of Morning Blood Pressure
Scientific Title Evaluation of Olmesartan on the Control of Morning Blood Pressure
Scientific Title:Acronym Evaluation of Olmesartan on the Control of Morning Blood Pressure
Region
Japan

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

Objectives
Narrative objectives1 Olmesartan shows 12 to 18 hours duration of anti-hypertensive action. The long action of olmesartan may show the equivalent effect on blood pressure (BP) control despite of different time of taking the drug. If the control of BP is equivalent regardless of whether taking drug in the morning or evening, administration of drug is possible adapting patient's life style. We conducted this study to clarify the effect of BP control with home blood pressure measurement equipment between the groups taking in the morning and evening. Also we evaluate renin, angiotensin I, II, aldosterone, urinary albumin, and hs-CRP of both patients groups.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Morning home blood pressure
Key secondary outcomes renin, angiotensin, aldosterone,Urinary albumin, hs-CRP

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 considered as a block.
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Take medicine after breakfast
Interventions/Control_2 Take medicine after supper
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient whose systolic blood pressure (BP) is over 140mmHg and/or diastolic BP is 90mmHg and not receives medication.
Key exclusion criteria Exclusion criteria as follows: Patients who are pregnant or possibility of pregnancy, possess hypersensitivity to olmesartan, who are suffering from secondary hypertension, lateral or bilateral stenosis of renal arteries, cerebro-vascular diseases, hyper-potassemia, severe hepatic diseases, or elevated creatinine over 3.0mg/dl. Patient who are taking NSAID or steroids regularly, who are less than 15 years old, who are suffering from malignant neoplasm. Patients who are not selected by attendant physician.
Target sample size 236

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Mori, Yokohama Sotetsu bldg clinic of internal medicine
Organization Kanagawa Association of Medical and Dental Practitioners
Division name Department of Clinical Research
Zip code
Address TS plaza bldg 2 F, 2-23-2, tsuruya-Cho, Kanagawa-Ku, Yokohama, Japan
TEL 045-313-2111
Email hmori@gem.hi-ho.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisao Mori
Organization Kanagawa Association of Medical and Dental Practitioners
Division name Department of Clinical Research
Zip code
Address TS plaza bldg 2 F, 2-23-2, tsuruya-Cho, Kanagawa-Ku, Yokohama, Japan
TEL 045-313-2111
Homepage URL http://www.jinbokyo.com/research/index.html
Email hmori@gem.hi-ho.ne.jp

Sponsor
Institute Kanagawa Association of Medical and Dental Practitioners
Institute
Department

Funding Source
Organization Kanagawa Association of Medical and Dental Practitioners
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

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
2005 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2005 Year 09 Month 01 Day
Last follow-up date
2010 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 23 Day
Last modified on
2014 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003921

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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