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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014