HypertensionCOMBATNCT00526279
COmpliance and Efficacy in Mono and Combination Tablet Study ATacand/Atacand Plus
An observational study of Hypertension, run by AstraZeneca at 3 sites in South Korea.
Trial summary
To evaluate compliance and patients' satisfaction in mono and combination treatment of Candesartan cilexetil (Atacand)/ Candesartan cilexetil 16mg, hydrochlorothiazide 12.5mg (Atacand plus) in hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 9,000 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jun 2007to Aug 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care
Who may be able to join
- Patients who have consented to participation/data release in this study
- Patients diagnosed with hypertension and prescribed with atacand/atacand plus by the physician based on clinical decision
Who cannot join
- Secondary hypertension requiring therapy other than antihypertensive medication
- Patients not prescribed with atacand/atacand plus based on safety reasons or any other reason as determined by the physician
- Women in pregnancy or lactation
- Patients enrolled in any other studies
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Research Site
Seoul, Jongro-gu
Research Site
Seoul, Kangnam-gu
Research Site
Seoul, Songpa-gu
About this study
Official title: A Prospective, Non-interventional, Observational, Multi-center Trial to Evaluate Compliance and Efficacy in Mono and Combination Treatment of Candesartan Cilexetil(Atacand)/ Candesartan Cilexetil 16mg, Hydrochlorothiazide 12.5mg(Atacand Plus) in Hypertension
To evaluate compliance and patients' satisfaction in mono and combination treatment of Candesartan cilexetil (Atacand)/ Candesartan cilexetil 16mg, hydrochlorothiazide 12.5mg (Atacand plus) in hypertension.
- Conditions
- Hypertension
- Keywords
- Hypertension, Atacand/Atacand plus, COMBAT, Compliance, Naturalistic, Observational
- Medical subject headings
- Hypertension, Patient Compliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hyunah Caroline Choi, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526279
- Sponsor's protocol ID
- NIS-CKR-ATA-2007/2
- Acronym
- COMBAT
- Status last verified
- Nov 2010
- First submitted
- 6 Sep 2007
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Observational, Multi-center Trial to Evaluate Compliance and Efficacy in Mono and Combination Treatment of Candesartan Cilexetil(Atacand)/ Candesartan Cilexetil 16mg, Hydrochlorothiazide 12.5mg(Atacand Plus) in Hypertension
- ClinicalTrials.gov ID
- NCT00526279
- Acronym / sponsor ID
- COMBAT / NIS-CKR-ATA-2007/2
- Conditions
- Hypertension
- Keywords
- Hypertension, Atacand/Atacand plus, COMBAT, Compliance, Naturalistic, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 10 Sep 2007 (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.
To evaluate compliance and patients' satisfaction in mono and combination treatment of Candesartan cilexetil (Atacand)/ Candesartan cilexetil 16mg, hydrochlorothiazide 12.5mg (Atacand plus) in hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care
Key inclusion criteria (2 listed)
- Patients who have consented to participation/data release in this study
- Patients diagnosed with hypertension and prescribed with atacand/atacand plus by the physician based on clinical decision
Key exclusion criteria (4 listed)
- Secondary hypertension requiring therapy other than antihypertensive medication
- Patients not prescribed with atacand/atacand plus based on safety reasons or any other reason as determined by the physician
- Women in pregnancy or lactation
- Patients enrolled in any other studies
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
Not reported in the source record.
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 1 Dec 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.
Hyunah Caroline Choi study director
AstraZeneca Korea
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by AstraZeneca at 3 sites in South Korea.
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 4 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 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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.
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 1 Dec 2010.