HypertensionCOUGHNCT01211171
COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH in Poland
An observational study of Hypertension, run by Bayer at 1 site in Poland.
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
- 2,498 participants
- Where
- 1 sitePoland
- Study dates
- May 2009to Dec 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 hypertensive patients with cough caused by the ACE-i regardless any other factors.
Who may be able to join
- age > 18
- ACE-I related cough Exclusion Criteria: - Current treatment with telmisartan
- Cholestatic disorders and severe hepatic failure
- Allergy to telmisartan
- Pregnancy and lactation period
Who cannot join
None listed.
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)
General tolerability and safety of telmisartan treatment 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 posted29 Sep 2010 (estimated)
- Study startMay 2009
- Primary completionDec 2009
- Study completionDec 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
- 2,498 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
- NCT01211171
- Sponsor's protocol ID
- 14881
- Other IDs
- KL0910PL, 15379 - KL0910SK, GM.2009-04-06.0017
- Acronym
- COUGH
- Status last verified
- Feb 2014
- First submitted
- 28 Sep 2010
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. 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
- NCT01211171
- Acronym / sponsor ID
- COUGH / 14881
- Conditions
- Hypertension
- Keywords
- Cough, Telmisartan, Bradykinin, Tolerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,498 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Sep 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 (5 listed)
- age > 18
- ACE-I related cough Exclusion Criteria: - Current treatment with telmisartan
- Cholestatic disorders and severe hepatic failure
- Allergy to telmisartan
- Pregnancy and lactation period
Key exclusion criteria (0 listed)
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
General tolerability and safety of telmisartan treatment 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 13 Feb 2014.
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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 Poland.
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 5 inclusion and 0 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 13 Feb 2014. 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 Poland. 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 13 Feb 2014.