HypertensionCOUGHNCT01217879
COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-i Treatment Due to couGH in Slovakia
An observational study of Hypertension, run by Bayer at 1 site in Slovakia.
Trial summary
In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the… 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)
- Type of treatment
- Pill or oral medicine
- How many people
- 980 participants
- Where
- 1 siteSlovakia
- Study dates
- Jan 2010to Sep 2010
- 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 hypertensive patients with cough caused by the ACE-I regardless any other factors.
Who may be able to join
- Hypertension
- Age > 18
- ACE-I related cough
Who cannot join
- Current treatment with telmisartan
- Cholestatic disorders and severe hepatic failure
- Allergy to telmisartan
- Pregnancy and lactation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cough Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop Previous ACE-i Treatment Due to Cough
In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. Because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.
- Conditions
- Hypertension
- Being tested
- Telmisartan (Kinzal/Pritor, BAY68-9291)
- Keywords
- Cough, Telmisartan, Bradykinin, Tolerability
- Medical subject headings
- Hypertension, Cough
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 treated with telmisartan tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough
Measured: 4 months after initiation
Secondary outcomes (1)
Number of Participants with Adverse Events among patients, who had to stop their previous ACE-I treatment due to cough
Measured: 4 months after initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
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
- 980 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
- NCT01217879
- Sponsor's protocol ID
- 15379
- Other IDs
- KL0910SK, 14881 - KL0910PL, GM.2009-04-06.0017
- Acronym
- COUGH
- Status last verified
- Nov 2012
- First submitted
- 6 Oct 2010
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cough Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop Previous ACE-i Treatment Due to Cough
- ClinicalTrials.gov ID
- NCT01217879
- Acronym / sponsor ID
- COUGH / 15379
- Conditions
- Hypertension
- Keywords
- Cough, Telmisartan, Bradykinin, Tolerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 980 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 8 Oct 2010 (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.
In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. Because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Telmisartan (Kinzal/Pritor, 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 hypertensive patients with cough caused by the ACE-I regardless any other factors.
Key inclusion criteria (3 listed)
- Hypertension
- Age > 18
- ACE-I related cough
Key exclusion criteria (4 listed)
- Current treatment with telmisartan
- 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 |
|---|---|---|
| Telmisartan (Kinzal/Pritor, BAY68-9291)Patients treated with telmisartan tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment | Drug | Group 1 |
Primary outcome
Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough
Time frame: 4 months after initiation
1 secondary outcome
Number of Participants with Adverse Events among patients, who had to stop their previous ACE-I treatment due to cough
Time frame: 4 months after initiation
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 16 Nov 2012.
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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 Slovakia.
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 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 16 Nov 2012. 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 Slovakia. 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?
Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough (time frame: 4 months after initiation). 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 16 Nov 2012.