Blood PressureNCT01182454
Clinical Test Report for Blood Pressure Meter of CH-658
An observational study of Blood Pressure, run by Citizen Systems Japan Co., Ltd. at 2 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- How many people
- 96 participants
- Where
- 2 sitesJapan
- Study dates
- Jan 2010to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: community sample
Who may be able to join
- 96 subjects with a wide range of blood pressure were selected.
Who cannot join
- Subjects could be taking antihypertensive medication, but excluded in atrial fibrillation or with any sustained arrhythmia.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
- Conditions
- Blood Pressure
- Keywords
- blood pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure accuracy of blood pressure meter CH-658
Measure the accuracy of blood pressure meter model CH-658 against the standard mercury sphygmomanometer according to the protocol of ANSI/AAMI SP-10
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Citizen Systems Japan Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182454
- Sponsor's protocol ID
- Citizen-658
- Status last verified
- Aug 2010
- First submitted
- 12 Aug 2010
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Test Report for Blood Pressure Meter of CH-658
- ClinicalTrials.gov ID
- NCT01182454
- Acronym / sponsor ID
- Citizen-658
- Conditions
- Blood Pressure
- Keywords
- blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Citizen Systems Japan Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 22 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- 96 subjects with a wide range of blood pressure were selected.
Key exclusion criteria (1 listed)
- Subjects could be taking antihypertensive medication, but excluded in atrial fibrillation or with any sustained arrhythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Citizen Systems Japan Co., Ltd. at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure accuracy of blood pressure meter CH-658 (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2010.