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COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH in Poland (COUGH)

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ClinicalTrials.gov Identifier: NCT01211171
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 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.

Condition or disease Intervention/treatment
Hypertension Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)

Study Design
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Study Type : Observational
Actual Enrollment : 2498 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH
Study Start Date : May 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
Drug Information available for: Telmisartan
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1 Drug: 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


Outcome Measures
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Primary Outcome Measures :
  1. Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough [ Time Frame: 4 months after initiation ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic hypertensive patients with cough caused by the ACE-i regardless any other factors.
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211171


Locations
Poland
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01211171     History of Changes
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 )
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by Bayer:
Cough
Telmisartan
Bradykinin
Tolerability

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action