HypertensionNCT00927537
Therapy of Essential Hypertension With Kinzal®/ Kinzalplus®
An observational study of Hypertension, run by Bayer at 1 site in Switzerland.
Trial summary
The efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed over 3-4 months Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan (Kinzal/Pritor, BAY68-9291) and Telmisartan (Kinzal/Pritor, BAY68-9291) + Hydrochlorothiazide
- How many people
- 2,052 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2008to Oct 2011
- 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: Community
Who may be able to join
- Hypertensive patients seen by the physician requiring antihypertensive treatment
Who cannot join
- According to the local drug information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Data Collection on Hypertension and Its Treatment With Kinzal®/ Kinzalplus®
The efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed over 3-4 months
- Conditions
- Hypertension
- Being tested
- Telmisartan (Kinzal/Pritor, BAY68-9291), Telmisartan (Kinzal/Pritor, BAY68-9291) + Hydrochlorothiazide
- 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.
Telmisartan (Kinzal/Pritor, BAY68-9291)Drug
Patients under daily life treatment receiving Kinzal according to local drug information.
Telmisartan (Kinzal/Pritor, BAY68-9291) + HydrochlorothiazideDrug
Patients under daily life treatment receiving Kinzalplus according to local drug information.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) | |
| Group 2 | Not described Receives: Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) + Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: After 1-2 weeks, 1month, 3-4 months
Secondary outcomes (5)
Change in Mean heart rate (bpm)
Measured: Baseline and 3-4 month
Change in Mean Weight (kg)
Measured: Baseline and 3-4 month
Change in Mean laboratory parameters (total cholesterol, LDL, HDL, triglyceride, fasting blood glucose)
Measured: Baseline and 3-4 month
Patient Medical History: Duration of hypertension, Pre-treatment of hypertension, Comorbidities and Concomitant treatment
Measured: Baseline
Final evaluation of efficacy (very good, good, sufficient, insufficient) and tolerability (very good, good, sufficient, insufficient) of treatment by the physician.
Measured: After 3-4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startApr 2008
- Primary completionOct 2011
- Study completionOct 2011
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
- 2,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927537
- Sponsor's protocol ID
- 13599
- Other IDs
- KL0810CH
- Status last verified
- Sep 2013
- First submitted
- 24 Jun 2009
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection on Hypertension and Its Treatment With Kinzal®/ Kinzalplus®
- ClinicalTrials.gov ID
- NCT00927537
- Acronym / sponsor ID
- 13599
- Conditions
- Hypertension
- Keywords
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,052 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Jun 2009 (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 efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed over 3-4 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) |
| Group 2 | – | Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) + Hydrochlorothiazide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community
Key inclusion criteria (1 listed)
- Hypertensive patients seen by the physician requiring antihypertensive treatment
Key exclusion criteria (1 listed)
- According to the local drug information
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 |
|---|---|---|
| Telmisartan (Kinzal/Pritor, BAY68-9291)Patients under daily life treatment receiving Kinzal according to local drug information. | Drug | Group 1 |
| Telmisartan (Kinzal/Pritor, BAY68-9291) + HydrochlorothiazidePatients under daily life treatment receiving Kinzalplus according to local drug information. | Drug | Group 2 |
Primary outcome
Blood pressure
Time frame: After 1-2 weeks, 1month, 3-4 months
5 secondary outcomes
Change in Mean heart rate (bpm)
Time frame: Baseline and 3-4 month
Change in Mean Weight (kg)
Time frame: Baseline and 3-4 month
Change in Mean laboratory parameters (total cholesterol, LDL, HDL, triglyceride, fasting blood glucose)
Time frame: Baseline and 3-4 month
Patient Medical History: Duration of hypertension, Pre-treatment of hypertension, Comorbidities and Concomitant treatment
Time frame: Baseline
Final evaluation of efficacy (very good, good, sufficient, insufficient) and tolerability (very good, good, sufficient, insufficient) of treatment by the physician.
Time frame: After 3-4 month
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 4 Sep 2013.
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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
1 site 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 Bayer at 1 site in Switzerland.
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 1 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 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Blood pressure (time frame: After 1-2 weeks, 1month, 3-4 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 4 Sep 2013.