Essential HypertensionCoCaNCT00608153
Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide
An observational study of Essential Hypertension, run by AstraZeneca.
Trial summary
The CoCa study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the subject compliance as well as the efficacy and tolerability of candesartan or candesartan/HCT in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Essential Hypertension
- How many people
- 1,773 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Sep 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care ambulant patient
Who may be able to join
- essential hypertension
- under candesartan treatment
Who cannot join
- -
About this study
The CoCa study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the subject compliance as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension.
- Conditions
- Essential Hypertension
- Keywords
- essential hypertension, ARB, compliance, candesartan
- Medical subject headings
- Essential Hypertension, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patient with essential hypertension under treatment with candesartan or candesartan HCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate under naturalistic conditions the compliance rate, defined as the number of subjects with regular intake of the prescribed dose of candesartan or candesartan/HCT as judged by the physician at the end of the observational period.
Measured: app. 3 monthly
Secondary outcomes (3)
To assess under naturalistic conditions the subject's reason(s) for being compliant or non-compliant with the intake of the pre-scribed dose of candesartan or candesartan/HCT
Measured: app. 3 monthly
To assess under naturalistic conditions the subject's reason(s) for withdrawal of the pre-scribed dose of candesartan or candesartan/HCT
Measured: app. 3 monthly
To assess under naturalistic conditions whether physicians are using procedures to improve the subject's compliance regarding the intake of candesartan or candesartan/HCT and to get insight in the type and effects of these procedures
Measured: app. 3 monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- R. E. Schmieder, MD, Principal investigator, University hospital Erlangen-NurnbergAndrea Pahor, MD, Study chair, MED Dep., AstraZeneca Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608153
- Sponsor's protocol ID
- NIS-CGE-ATA-2007/1
- Acronym
- CoCa
- Status last verified
- Jan 2008
- First submitted
- 23 Jan 2008
- Last updated
- 6 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide
- ClinicalTrials.gov ID
- NCT00608153
- Acronym / sponsor ID
- CoCa / NIS-CGE-ATA-2007/1
- Conditions
- Essential Hypertension
- Keywords
- essential hypertension, ARB, compliance, candesartan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,773 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 6 Feb 2008 (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 CoCa study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the subject compliance as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patient with essential hypertension under treatment with candesartan or candesartan HCT |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care ambulant patient
Key inclusion criteria (2 listed)
- essential hypertension
- under candesartan treatment
Key exclusion criteria (1 listed)
- -
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
To estimate under naturalistic conditions the compliance rate, defined as the number of subjects with regular intake of the prescribed dose of candesartan or candesartan/HCT as judged by the physician at the end of the observational period.
Time frame: app. 3 monthly
3 secondary outcomes
To assess under naturalistic conditions the subject's reason(s) for being compliant or non-compliant with the intake of the pre-scribed dose of candesartan or candesartan/HCT
Time frame: app. 3 monthly
To assess under naturalistic conditions the subject's reason(s) for withdrawal of the pre-scribed dose of candesartan or candesartan/HCT
Time frame: app. 3 monthly
To assess under naturalistic conditions whether physicians are using procedures to improve the subject's compliance regarding the intake of candesartan or candesartan/HCT and to get insight in the type and effects of these procedures
Time frame: app. 3 monthly
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 6 Feb 2008.
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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.
R. E. Schmieder, MD principal investigator
University hospital Erlangen-Nurnberg
Andrea Pahor, MD study chair
MED Dep., AstraZeneca Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension, 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 2 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 6 Feb 2008. 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?
To estimate under naturalistic conditions the compliance rate, defined as the number of subjects with regular intake of the prescribed dose of candesartan or candesartan/HCT as judged by the physician at the end of the observational period. (time frame: app. 3 monthly). 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 6 Feb 2008.