- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01182454
Clinical Test Report for Blood Pressure Meter of CH-658
August 13, 2010 updated by: Citizen Systems Japan Co., Ltd.
Blood pressure meter model CH-658 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
96
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tokyo, Japan
- Sone Clinic
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Toyko, Japan
- Sone Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 62 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
community sample
Description
Inclusion Criteria:
- 96 subjects with a wide range of blood pressure were selected.
Exclusion Criteria:
- Subjects could be taking antihypertensive medication, but excluded in atrial fibrillation or with any sustained arrhythmia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure accuracy of blood pressure meter CH-658
Time Frame: 30 minutes
|
Measure the accuracy of blood pressure meter model CH-658 against the standard mercury sphygmomanometer according to the protocol of ANSI/AAMI SP-10
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
August 12, 2010
First Submitted That Met QC Criteria
August 13, 2010
First Posted (Estimate)
August 16, 2010
Study Record Updates
Last Update Posted (Estimate)
August 16, 2010
Last Update Submitted That Met QC Criteria
August 13, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Citizen-658
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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