HypertensionNCT00709787
Epidemiological Study In Hypertensive Patients: Assessment Of Risk Factors Prevalence And Of Patients' Management
An observational study of Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 2 sites in 2 countries.
Trial summary
To assess the pattern of hypertension in the population in terms of presence of additional risk factors (ARF) and cardiovascular risk stratification. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- How many people
- 899 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2008to Feb 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Hypertensive Patients managed in primary care
Who may be able to join
- Age 18 to 80 years old
- Patients with hypertension: newly diagnosed and /or already diagnosed and treated , whether at goal or not for the blood pressure level;
- Patients with no history of CHD/CVD
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
To assess the pattern of hypertension in the population in terms of presence of additional risk factors (ARF) and cardiovascular risk stratification.
Read the detailed description
routine physician visits
- Conditions
- Hypertension
- Being tested
- Usual Care
- Keywords
- Epidemiology, hypertension, risk factors, coronary heart disease, patient management, compliance with medication
- Medical subject headings
- Hypertension, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Normal care for hypertensive patients with risk factors for CHD
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive Subjects undergoing primary prevention | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of hypertensive patients in terms of presence of associated cardiovascular (CV) risk factors (number of additional CV risk factors and frequency)
Secondary outcomes (3)
Description of pattern of management of HT and CVD prevention, through lifestyle and use of drug therapies,
Estimate adherence to treatment using the Morisky Adherence Scale (MAS)
Estimation of hypertensive patients CV risk stratification based on ESH/ESC Hypertension Guidelines 2007 and to compare it with physicians' estimation of CV risk.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
- Study completionFeb 2009
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.
- 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
- 899 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709787
- Sponsor's protocol ID
- A3841059
- Status last verified
- Jan 2021
- First submitted
- 1 Jul 2008
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study In Hypertensive Patients: Assessment Of Risk Factors Prevalence And Of Patients' Management
- ClinicalTrials.gov ID
- NCT00709787
- Acronym / sponsor ID
- A3841059
- Conditions
- Hypertension
- Keywords
- Epidemiology, hypertension, risk factors, coronary heart disease, patient management, compliance with medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 899 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 3 Jul 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.
To assess the pattern of hypertension in the population in terms of presence of additional risk factors (ARF) and cardiovascular risk stratification.
Detailed description
routine physician visits
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive Subjects undergoing primary prevention | – | Other: Usual Care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Hypertensive Patients managed in primary care
Key inclusion criteria (3 listed)
- Age 18 to 80 years old
- Patients with hypertension: newly diagnosed and /or already diagnosed and treated , whether at goal or not for the blood pressure level;
- Patients with no history of CHD/CVD
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareNormal care for hypertensive patients with risk factors for CHD | Other | Hypertensive Subjects undergoing primary prevention |
Primary outcome
Description of hypertensive patients in terms of presence of associated cardiovascular (CV) risk factors (number of additional CV risk factors and frequency)
3 secondary outcomes
Description of pattern of management of HT and CVD prevention, through lifestyle and use of drug therapies,
Estimate adherence to treatment using the Morisky Adherence Scale (MAS)
Estimation of hypertensive patients CV risk stratification based on ESH/ESC Hypertension Guidelines 2007 and to compare it with physicians' estimation of CV risk.
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 27 Jan 2021.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 2 sites in 2 countries.
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 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia, Czechia. 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?
Description of hypertensive patients in terms of presence of associated cardiovascular (CV) risk factors (number of additional CV risk factors and frequency). 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 27 Jan 2021.