Assessment of Compliance With Antihypertensive Telmisartan Therapy

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)

• Registration Number: NCT00470886
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to asses the efficacy and safety of Telmisartan depending on the use of an electronic therapy monitoring device (HelpingHand) in a real life setting and to asses patients compliance to the therapy with Telmisartan in relation to use of electronic therapy monitoring device.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-07
• Study First Submitted QC: 2007-05-07
• Study First Posted: 2007-05-08
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-14
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3400

Inclusion Criteria

• Age over 18
• Untreated or ineffectively treated arterial hypertension

Exclusion Criteria

• Cholestatic disorders and severe hepatic failure
• Allergy to Telmisartan
• Pregnancy and lactation period
• Unwillingness to participate in the study
• Inability to use the drug reminder device
• Unwillingness to use the drug reminder device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Telmisartan (Kinzal/Pritor, BAY68-9291)	-

Primary Outcome Measures

Name	Time	Method
Efficacy and safety of the treatment with telmisartan reported by the physician with regard to usage the HelpingHand device	At all four planned control visits. (Approx. interval between visits 3 months)

Secondary Outcome Measures

Name	Time	Method
Compliance with the treatment calculated on the basis of by HelpingHand and patients questionnaires	At all four planned control visits. (Approx. interval between visits 3 months)