check_circleStudy Completed

Hypertension

Bayer Identifier:

15379

ClinicalTrials.gov Identifier:

NCT01217879

EudraCT Number:

Not Available

EU CT Number:

Not Available
COugh among hypertensive patients treated with telmisartan, who had to stop previoUs ACE-i treatment due to couGH in Slovakia

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Hypertension
    - Age > 18
    - ACE-I related cough


  • - Current treatment with telmisartan
    - Cholestatic disorders and severe hepatic failure
    - Allergy to telmisartan
    - Pregnancy and lactation period

Trial summary

Enrollment Goal
980
Trial Dates
January 2010 - September 2010
Phase
N/A
Could I Receive a placebo
No
Products
Kinzal/Pritor (Telmisartan, BAY68-9291)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Slovakia

Primary Outcome

  • Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough
    date_rangeTime Frame:
    4 months after initiation
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    Safety Issue:
    Yes

Secondary Outcome

  • Number of Participants with Adverse Events among patients, who had to stop their previous ACE-I treatment due to cough
    date_rangeTime Frame:
    4 months after initiation
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Cough among hypertensive patients treated with telmisartan, who had to stop previous ACE-i treatment due to cough
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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