Blood PressureNCT01029119
Clinical Test for Blood Pressure Meter of CH-101
An observational study of Blood Pressure, run by Citizen Systems Japan Co., Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- How many people
- 85 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2006to Feb 2007
- 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 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 85 subjects with a wide range of blood pressure were selected.
Who cannot join
- Subjects could be taking antihypertension medication, but excluded in atrial fibrillation or with any sustained arrhythmia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Test of Blood Pressure Meter of CH-101
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.
- Conditions
- Blood Pressure
- Keywords
- blood pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted9 Dec 2009 (estimated)
- Study startAug 2006
- Primary completionFeb 2007
- Study completionFeb 2007
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
- 85 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
- NCT01029119
- Sponsor's protocol ID
- Citizen - CH101
- Status last verified
- Dec 2009
- First submitted
- 7 Dec 2009
- Last updated
- 9 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Test of Blood Pressure Meter of CH-101
- ClinicalTrials.gov ID
- NCT01029119
- Acronym / sponsor ID
- Citizen - CH101
- Conditions
- Blood Pressure
- Keywords
- blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Citizen Systems Japan Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 9 Dec 2009 (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-101 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 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- 85 subjects with a wide range of blood pressure were selected.
Key exclusion criteria (1 listed)
- Subjects could be taking antihypertension 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 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.
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 9 Dec 2009.
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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.
1 site 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 1 site in Taiwan.
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 9 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 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.). 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 9 Dec 2009.