High Blood PressureNCT01274494
COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication
An observational study of High Blood Pressure, run by AstraZeneca.
Trial summary
The aim of this multi-centre survey is to assess treatment adherence and quality of life in a Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled essential hypertension being on antihypertensive treatment for at least 6 months. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- High Blood Pressure
- How many people
- 1,501 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Sep 2012
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: multi-centre survey of patients
Who may be able to join
- Patients older than 21 years of age
- Patients newly diagnosis with essential hypertension or with hypertension that is uncontrolled after being under the same antihypertensive treatment for at least 6 months (based on the criteria established by the Joint National Committee VII)
- Patients capable of providing an informed consent
Who cannot join
- Patients with secondary hypertension
- Pregnant women or nursing mothers
- Patients with acute illnesses or psychiatric diagnosis
About this study
The aim of this multi-centre survey is to assess treatment adherence and quality of life in a Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled essential hypertension being on antihypertensive treatment for at least 6 months.
- Conditions
- High Blood Pressure
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate
Identify the percentage of subjects compliant to their antihypertensive treatment.
Measured: 6 months
Secondary outcomes (5)
Health Related Quality of Life (MINICHAL Score)
To compare and identify changes in the quality of life before and after anti-hypertensive treatment.
Measured: 6 months
Type of pharmacological treatments
To identify the pharmacological treatments used by physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension.
Measured: 6 months
Factors affecting adherence to treatment
To identify associated factors that may alter adherence to anti-hypertensive treatment.
Measured: 6 months
Compliance rate by antihypertensive regimen used
To compare treatment rate for different antihypertensive regimen used
Measured: 6 months
Percentage of controlled patients
To identify the percentage of patients reaching their target blood pressure according to the JNCVII criteria.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 1,501 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274494
- Sponsor's protocol ID
- NIS-CME-ATA-2010/1
- Status last verified
- Sep 2013
- First submitted
- 10 Jan 2011
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication
- ClinicalTrials.gov ID
- NCT01274494
- Acronym / sponsor ID
- NIS-CME-ATA-2010/1
- Conditions
- High Blood Pressure
- Keywords
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,501 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Jan 2011 (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.
The aim of this multi-centre survey is to assess treatment adherence and quality of life in a Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled essential hypertension being on antihypertensive treatment for at least 6 months.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- multi-centre survey of patients
Key inclusion criteria (3 listed)
- Patients older than 21 years of age
- Patients newly diagnosis with essential hypertension or with hypertension that is uncontrolled after being under the same antihypertensive treatment for at least 6 months (based on the criteria established by the Joint National Committee VII)
- Patients capable of providing an informed consent
Key exclusion criteria (3 listed)
- Patients with secondary hypertension
- Pregnant women or nursing mothers
- Patients with acute illnesses or psychiatric diagnosis
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
Compliance rate
Time frame: 6 months
Identify the percentage of subjects compliant to their antihypertensive treatment.
5 secondary outcomes
Health Related Quality of Life (MINICHAL Score)
Time frame: 6 months
Type of pharmacological treatments
Time frame: 6 months
Factors affecting adherence to treatment
Time frame: 6 months
Compliance rate by antihypertensive regimen used
Time frame: 6 months
Percentage of controlled patients
Time frame: 6 months
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 11 Sep 2013.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of High Blood Pressure, run by AstraZeneca.
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 3 inclusion and 3 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 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Compliance rate (time frame: 6 months). 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 11 Sep 2013.