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

September 28, 2010
February 11, 2014
May 2009
December 2009   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01211171 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH in Poland
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Primary care clinic hypertensive patients with cough caused by the ACE-i regardless any other factors.

Hypertension
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
Group 1
Intervention: Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2498
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01211171
14881, KL0910PL, 15379 - KL0910SK, GM.2009-04-06.0017
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP