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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01211171
First received: September 28, 2010
Last updated: February 11, 2014
Last verified: February 2014
  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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 2498
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211171

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01211171     History of Changes
Other Study ID Numbers: 14881, KL0910PL, 15379 - KL0910SK, GM.2009-04-06.0017
Study First Received: September 28, 2010
Last Updated: February 11, 2014
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Bayer:
Cough
Telmisartan
Bradykinin
Tolerability

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014