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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01217879
First Posted: October 8, 2010
Last Update Posted: November 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  Purpose
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 Intervention
Hypertension Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 980
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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): NCT01217879


Locations
Slovakia
Many Locations, Slovakia
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Director, Bayer s. r. o, Obchodna 2, 811 06 Bratislava
ClinicalTrials.gov Identifier: NCT01217879     History of Changes
Other Study ID Numbers: 15379
KL0910SK ( Other Identifier: Company internal )
14881 - KL0910PL ( Other Identifier: Company internal )
GM.2009-04-06.0017 ( Other Identifier: Company internal )
First Submitted: October 6, 2010
First Posted: October 8, 2010
Last Update Posted: November 16, 2012
Last Verified: November 2012

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