Essential HypertensionNCT00802542
In-practice Evaluation of Atacand 16mg Antihypertensive Effect
An observational study of Essential Hypertension, run by AstraZeneca at 4 sites in Latvia.
Trial summary
The purpose of this study is to prove in practice the effectiveness of Atacand 16 mg in reducing blood pressure after 4 weeks of administration and the importance of administration of adequate doses Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension
- How many people
- 400 participants
- Where
- 4 sitesLatvia
- Study dates
- Nov 2008to Jan 2009
- 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: out-patient departments
Who may be able to join
- Adult patients with mild (140-159/90-99 mgHg) to moderate (160-179/100-109 mmHg) essential hypertension, already treated with Atacand 8mg for 2-4 weeks, who have not reached the blood pressure treatment goal at least <140/90 mgHg and the doctor has decided
- Signed and dated Patient Informed Consent (ICF)
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients of Atacand.
Trial locations and contacts
4 sites in 1 country.
Latvia4 sites
Research site
Daugavpils
Research site
Jelgava
Research site
Liepāja
Research Site
Riga
About this study
The purpose of this study is to prove in practice the effectiveness of Atacand 16 mg in reducing blood pressure after 4 weeks of administration and the importance of administration of adequate doses
- Conditions
- Essential Hypertension
- Keywords
- Hypertension, blood pressure, Atacand
- Medical subject headings
- Essential Hypertension, Hypertension
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 | Adult patients with mild or moderate essential hypertension who do not tolerate ACE inhibitors because of cough, already treated with Atacand 8mg for 2-4 weeks, who have not reached the blood pressure treatment goal and the doctor has decided to increase the Atacand dose to 16mg as per SmPC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in blood pressure
Measured: once after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2009
- Study completionJan 2009
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Agrita Hartmane, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802542
- Sponsor's protocol ID
- NIS-CLV-ATA-2008/1
- Status last verified
- Dec 2010
- First submitted
- 4 Dec 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-practice Evaluation of Atacand 16mg Antihypertensive Effect
- ClinicalTrials.gov ID
- NCT00802542
- Acronym / sponsor ID
- NIS-CLV-ATA-2008/1
- Conditions
- Essential Hypertension
- Keywords
- Hypertension, blood pressure, Atacand
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 Dec 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 purpose of this study is to prove in practice the effectiveness of Atacand 16 mg in reducing blood pressure after 4 weeks of administration and the importance of administration of adequate doses
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Adult patients with mild or moderate essential hypertension who do not tolerate ACE inhibitors because of cough, already treated with Atacand 8mg for 2-4 weeks, who have not reached the blood pressure treatment goal and the doctor has decided to increase the Atacand dose to 16mg as per SmPC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- out-patient departments
Key inclusion criteria (2 listed)
- Adult patients with mild (140-159/90-99 mgHg) to moderate (160-179/100-109 mmHg) essential hypertension, already treated with Atacand 8mg for 2-4 weeks, who have not reached the blood pressure treatment goal at least <140/90 mgHg and the doctor has decided
- Signed and dated Patient Informed Consent (ICF)
Key exclusion criteria (1 listed)
- Hypersensitivity to the active substance or to any of the excipients of Atacand.
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
Decrease in blood pressure
Time frame: once after 4 weeks
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 3 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.
Agrita Hartmane study director
AstraZeneca
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension, run by AstraZeneca at 4 sites in Latvia.
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 3 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 4 sites in Latvia. 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?
Decrease in blood pressure (time frame: once after 4 weeks). 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 3 Dec 2010.