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

NCT01211171 | Completed

• 4 other identifiers: 14881KL0910PL15379 - KL0910SKGM.2009-04-06.0017
• Study Type: observational
• Target: 2,498
• Locations: 1 country
• Sites: 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.

Conditions

Hypertension

Keywords

Cough; Telmisartan; Bradykinin; Tolerability

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)

• General tolerability and safety of telmisartan treatment among patients, who had to stop their previous ACE-I treatment due to cough

  4 months after initiation

Study Arms (1)

Group 1

Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)

Interventions

Telmisartan (Kinzal/Pritor, BAY68-9291) DRUG

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• age \> 18

You may not qualify if:

• Cholestatic disorders and severe hepatic failure
• Allergy to telmisartan
• Pregnancy and lactation period

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Poland

Location

MeSH Terms

Conditions

Hypertension; Cough

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: May 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

PL (1)