UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001276 |
|---|---|
| Receipt number | R000001550 |
| Scientific Title | Japan Home versus Office Measurement Evaluation for Heart Rate study |
| Date of disclosure of the study information | 2008/08/01 |
| Last modified on | 2010/02/01 12:39:54 |
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Basic information
Public title
Japan Home versus Office Measurement Evaluation for Heart Rate study
Acronym
J-HOME-HR study
Scientific Title
Japan Home versus Office Measurement Evaluation for Heart Rate study
Scientific Title:Acronym
J-HOME-HR study
Region
| Japan |
Condition
Condition
Essential Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness of beta blockers on home heart rate and home blood pressure among essential hypertension with high home heart rate
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Home heart rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of beta blockers
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Essential hypertensive patient receiving antihypertensive drug, 2.Patient who have been measured home blood pressure using upper-arm cuff device, 3.Patient with averaged morning home systolic BP >=135 mmHg and/or diastolic BP >=85 mmHg and averaged morning home heart rate >= 65bpm, 4.Patient who can measure electrocardiogram at home or in the office, 5.Patient aged 20-79 years
Key exclusion criteria
1.Taking beta blockers, anti arrhythmic drug, cardio tonic, or bradycardiac drug within a month, 2.Contraindications or hypersensitivity to beta blockers use, 3.Pulmonary disease, severe diabetes mellitus, or hyperthyroidism, 4.Malignant hypertension, 5.Secondary hypertension, 6.Not available for informed consent, 7.Participating other intervention trials, 8.Severe complications leading to stop this study, 9.Other inappropriate conditions judged by each physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Imai Yutaka |
Organization
Tohoku University Graduate School of Pharmaceutical Sciences and Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, 980-8574, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tohoku University Graduate School of Pharmaceutical Sciences and Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
TEL
Homepage URL
iyaku-kifu@mail.tains.tohoku.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology and Therapeutics, Tohoku University Graduate School of Pharmaceutical Sciences and Medicine
Institute
Department
Personal name
Funding Source
Organization
21st COE program 'Comprehensive Research and Education Center for Planning of Drug Development and Clinical Evaluation', Tohoku University Graduate School of Pharmaceutical Sciences
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
| 2008 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2008 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 07 | Month | 30 | Day |
Last modified on
| 2010 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001550
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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