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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)

• Study Type: Observational
• Enrollment (Actual): 980

Contacts and Locations

Study Locations

• Slovakia
  • Many Locations, Slovakia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough	4 months after initiation

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events among patients, who had to stop their previous ACE-I treatment due to cough	4 months after initiation

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: October 6, 2010
• First Submitted That Met QC Criteria: October 7, 2010
• First Posted (Estimate): October 8, 2010

Study Record Updates

• Last Update Posted (Estimate): November 16, 2012
• Last Update Submitted That Met QC Criteria: November 14, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Cough; Telmisartan; Bradykinin; Tolerability
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan
• Other Study ID Numbers: 15379; GM.2009-04-06.0017 (Other Identifier: Company internal); KL0910SK (Other Identifier: Company internal); 14881 - KL0910PL (Other Identifier: Company internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No