Assessment of Compliance With Antihypertensive Telmisartan Therapy (COAST)

November 14, 2012 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Primary care clinic hypertensive patients for whom physician decided to start the treatment with telmisartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
At all four planned control visits. (Approx. interval between visits 3 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
At all four planned control visits. (Approx. interval between visits 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

May 7, 2007

First Submitted That Met QC Criteria

May 7, 2007

First Posted (Estimate)

May 8, 2007

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

Other Study ID Numbers

  • 12827
  • KL0710PL (Other Identifier: Company)
  • 14237 - KL0710SK (Other Identifier: Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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