HypertensionMETABOLICNCT00471003
The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension
An observational study of Hypertension, run by Bayer at 4 sites in 4 countries.
Trial summary
The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Pritor (Telmisartan , BAY68-9291)
- How many people
- 5,448 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2006to Nov 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: Primary care clinic
Who may be able to join
- Age over 18
- Untreated or ineffectively treated arterial hypertension
Who cannot join
- Cholestatic disorders and severe hepatic failure
- Allergy to telmisartan
- Pregnancy and lactation period
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Asses the Efficacy and Safety of Telmisartan, With the Special Attention on the Influence of Telmisartan on Selected Metabolic Parameters of Patients
The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.
- Conditions
- Hypertension
- Being tested
- Pritor (Telmisartan , BAY68-9291)
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pritor (Telmisartan , BAY68-9291)Drug
Primary care hypertensive patients starting the therapy with Telmisartan
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Not described Receives: Drug: Pritor (Telmisartan , BAY68-9291) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of the treatment with telmisartan reported by the physician
Measured: At the both of planned control visits. (Approx. interval between visits 3 months)
Secondary outcomes (1)
Changes in metabolic parameters in telmisartan treated patients
Measured: At the both of planned control visits. (Approx. interval between visits 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2007 (estimated)
- Study startSep 2006
- Primary completionNov 2009
- Study completionNov 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.
- More trials run by BayerThe 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
- 5,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471003
- Sponsor's protocol ID
- 12729
- Other IDs
- KL0601PL, 13929 - KL0601SI, 12804 - KL0601SK, 14326 - KL0601HR
- Acronym
- METABOLIC
- Status last verified
- Jan 2010
- First submitted
- 7 May 2007
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Asses the Efficacy and Safety of Telmisartan, With the Special Attention on the Influence of Telmisartan on Selected Metabolic Parameters of Patients
- ClinicalTrials.gov ID
- NCT00471003
- Acronym / sponsor ID
- METABOLIC / 12729
- Conditions
- Hypertension
- Keywords
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,448 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 May 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.
The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Drug: Pritor (Telmisartan , BAY68-9291) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Age over 18
- Untreated or ineffectively treated arterial hypertension
Key exclusion criteria (3 listed)
- Cholestatic disorders and severe hepatic failure
- Allergy to telmisartan
- Pregnancy and lactation period
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 |
|---|---|---|
| Pritor (Telmisartan , BAY68-9291)Primary care hypertensive patients starting the therapy with Telmisartan | Drug | Arm 1 |
Primary outcome
Efficacy and safety of the treatment with telmisartan reported by the physician
Time frame: At the both of planned control visits. (Approx. interval between visits 3 months)
1 secondary outcome
Changes in metabolic parameters in telmisartan treated patients
Time frame: At the both of planned control visits. (Approx. interval between visits 3 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 20 Jan 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.
Bayer Study Director study director
Bayer
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Bayer at 4 sites in 4 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 2 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 20 Jan 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 Croatia, Poland, Slovakia, Slovenia. 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?
Efficacy and safety of the treatment with telmisartan reported by the physician (time frame: At the both of planned control visits. (Approx. interval between visits 3 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 20 Jan 2010.