UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005047 |
|---|---|
| Receipt number | R000006002 |
| Scientific Title | Effect of evening regimen on blood pressure control in patients with morning hypertension |
| Date of disclosure of the study information | 2011/02/08 |
| Last modified on | 2011/02/08 14:40:05 |
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Basic information
Public title
Effect of evening regimen on blood pressure control in patients with morning hypertension
Acronym
Effect of evening regimen on blood pressure control in patients with morning hypertension
Scientific Title
Effect of evening regimen on blood pressure control in patients with morning hypertension
Scientific Title:Acronym
Effect of evening regimen on blood pressure control in patients with morning hypertension
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study was conducted to evaluate clinically effective treatment of morning hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood pressure(On visit/Home monitoring)
Key secondary outcomes
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
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
In the combination therapy, either CCB or ARB was chosen. The administration after breakfast was changed into that at bedtime. Three months. Seventy patients.
Interventions/Control_2
In the combination therapy, either CCB or ARB was chosen. The administration after breakfast was changed. The dose was unchanged and given twice a day, i.e., after breakfast and at bedtime.Three months. Seventy patients.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects were patients aged 40 years or older with hypertension. They were treated with CCB or ARB monotherapy or combination therapy with agents including CCB and ARB for at least 4 weeks and in whom the mean morning blood pressure at home for 5 days of one week prior to enrollment was 135/85 mmHg or higher.
Key exclusion criteria
The exclusion criteria were apparently poor control of blood pressure, secondary hypertension, difficulty in walking by oneself, hemodialysis, malignant disorder and pregnancy.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuji Imai |
Organization
Imai Heart Clinic
Division name
Director
Zip code
Address
AminasuKitanoda204-1, 1077,Kitanoda, Higashi-ku, Sakai-shi, Osaka, Japan
TEL
072-235-4401
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuji Imai |
Organization
Imai Heart Clinic
Division name
Director
Zip code
Address
AminasuKitanoda204-1, 1077,Kitanoda, Higashi-ku, Sakai-shi, Osaka, Japan
TEL
072-235-4401
Homepage URL
imai-hc@umin.ac.jp
Sponsor or person
Institute
Sakai Cardiovascular Clinical Conference
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 02 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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 | 02 | Month | 08 | Day |
Last modified on
| 2011 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006002
