COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-i Treatment Due to couGH in Slovakia
COUGH
Cough Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop Previous ACE-i Treatment Due to Cough
4 other identifiers
observational
980
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 6, 2010
CompletedFirst Posted
Study publicly available on registry
October 8, 2010
CompletedNovember 16, 2012
November 1, 2012
8 months
October 6, 2010
November 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough
4 months after initiation
Secondary Outcomes (1)
Number of Participants with Adverse Events among patients, who had to stop their previous ACE-I treatment due to cough
4 months after initiation
Study Arms (1)
Group 1
Interventions
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 Criteria
Primary care clinic hypertensive patients with cough caused by the ACE-I regardless any other factors.
You may qualify if:
- Hypertension
- Age \> 18
- ACE-I related cough
You may not qualify if:
- Current treatment with telmisartan
- Cholestatic disorders and severe hepatic failure
- Allergy to telmisartan
- Pregnancy and lactation period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Many Locations, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 6, 2010
First Posted
October 8, 2010
Study Start
January 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
November 16, 2012
Record last verified: 2012-11