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

Hypertension Clinical Trial

— COUGH  

Official title:

Cough Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop Previous ACE-i Treatment Due to Cough

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217879
• Other study ID #: 15379
• Secondary ID: KL0910SK14881 -
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: November 14, 2012
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: November 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 980
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough		4 months after initiation	Yes
Secondary	Number of Participants with Adverse Events among patients, who had to stop their previous ACE-I treatment due to cough		4 months after initiation	Yes

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