UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003238 |
|---|---|
| Receipt number | 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 15:08:58 |
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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
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
hmori@gem.hi-ho.ne.jp
Sponsor or person
Institute
Kanagawa Association of Medical and Dental Practitioners
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003921
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
