- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01211171
COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH in Poland (COUGH)
February 11, 2014 updated by: Bayer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2498
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Many Locations, Poland
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Primary care clinic hypertensive patients with cough caused by the ACE-i regardless any other factors.
Description
Inclusion Criteria: - hypertension
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough
Time Frame: 4 months after initiation
|
4 months after initiation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
4 months after initiation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 28, 2010
First Submitted That Met QC Criteria
September 28, 2010
First Posted (Estimate)
September 29, 2010
Study Record Updates
Last Update Posted (Estimate)
February 13, 2014
Last Update Submitted That Met QC Criteria
February 11, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14881
- KL0910PL (Other Identifier: Company internal)
- 15379 - KL0910SK (Other Identifier: Company internal)
- GM.2009-04-06.0017 (Other Identifier: Company internal)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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