Compliance With Antihypertensive Telmisartan Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

May 7, 2007

Last Updated Date

February 23, 2010

Start Date ^ICMJE

April 2007

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy and safety of the treatment with telmisartan reported by the physician with regard to usage the HelpingHand device [ Time Frame: At all four planned control visits. (Approx. interval between visits 3 months) ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00470886 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Compliance with the treatment calculated on the basis of by HelpingHand and patients questionnaires [ Time Frame: At all four planned control visits. (Approx. interval between visits 3 months) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Compliance With Antihypertensive Telmisartan Therapy

Official Title ^ICMJE

A Non-Interventional, Post-Marketing Surveillance, Phase IV Study to Assess Compliance With Antihypertensive Telmisartan Therapy

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

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

Primary care clinic hypertensive patients for whom physician decided to start the treatment with telmisartan

Study Arms / Comparison Groups

Group 1

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3300

Completion Date

January 2010

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland, Slovakia

Administrative Information

NCT ID ^ICMJE

NCT00470886

Responsible Party

Medical Director, Bayer Sp. z o.o.

Study ID Numbers ^ICMJE

12827, KL0710PL, KL0710SK, 14237

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Bang & Olufsen Medicom

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP