Clinical Test for Blood Pressure Meter of CH-101

This study has been completed.

Sponsor:

Information provided by:

Citizen Systems Japan Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01029119

First received: December 7, 2009

Last updated: December 8, 2009

Last verified: December 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	December 7, 2009
Last Updated Date	December 8, 2009
Start Date ^ICMJE	August 2006
Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 8, 2009)	Measure the accuracy of blood pressure meter model CH-101 assessed against the standard mercury sphygmomanometer according to the protocol of ANSI/AAMi SP-10. [ Time Frame: 30 minutes. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01029119 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Test for Blood Pressure Meter of CH-101
Official Title ^ICMJE	Clinical Test of Blood Pressure Meter of CH-101
Brief Summary	Blood pressure meter model CH-101 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Community sample
Condition ^ICMJE	Blood Pressure
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	85
Completion Date	February 2007
Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 85 subjects with a wide range of blood pressure were selected. Exclusion Criteria: Subjects could be taking antihypertension medication, but excluded in atrial fibrillation or with any sustained arrhythmia.
Gender	Both
Ages	22 Years to 84 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Taiwan

Administrative Information
NCT Number ^ICMJE	NCT01029119
Other Study ID Numbers ^ICMJE	Citizen - CH101
Has Data Monitoring Committee	No
Responsible Party	Makoto Okamoto, Citizen Systems Japan, Co. Ltd.
Study Sponsor ^ICMJE	Citizen Systems Japan Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Citizen Systems Japan Co., Ltd.
Verification Date	December 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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