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:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01211171
First received: September 28, 2010
Last updated: February 11, 2014
Last verified: February 2014
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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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01211171
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:
| 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:
|
Cough Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Telmisartan Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 28, 2016