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Clinical Test Report for Blood Pressure Meter of CH-658

This study has been completed.
Sponsor:
Information provided by:
Citizen Systems Japan Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01182454
First received: August 12, 2010
Last updated: August 13, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition
Blood Pressure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Further study details as provided by Citizen Systems Japan Co., Ltd.:

Primary Outcome Measures:
  • Measure accuracy of blood pressure meter CH-658 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Measure the accuracy of blood pressure meter model CH-658 against the standard mercury sphygmomanometer according to the protocol of ANSI/AAMI SP-10


Enrollment: 96
Study Start Date: January 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   22 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

community sample

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182454

Locations
Japan
Sone Clinic
Tokyo, Japan
Sone Clinic
Toyko, Japan
Sponsors and Collaborators
Citizen Systems Japan Co., Ltd.
  More Information

No publications provided

Responsible Party: Makoto Okamoto, Citizen Systems Japan Co., Ltd.
ClinicalTrials.gov Identifier: NCT01182454     History of Changes
Other Study ID Numbers: Citizen-658
Study First Received: August 12, 2010
Last Updated: August 13, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Citizen Systems Japan Co., Ltd.:
blood pressure

ClinicalTrials.gov processed this record on May 22, 2013