Assessment of Compliance With Antihypertensive Telmisartan Therapy (COAST)

This study has been completed.
Bang & Olufsen Medicom
Information provided by:
Bayer Identifier:
First received: May 7, 2007
Last updated: November 14, 2012
Last verified: November 2012
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Interventional, Post-Marketing Surveillance, Phase IV Study to Assess Compliance With Antihypertensive Telmisartan Therapy

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3400
Study Start Date: April 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)
Primary care clinic hypertensive patients for whom physician decided to start the treatment with telmisartan


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic hypertensive patients for whom physician decided to start the treatment with telmisartan

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00470886

Many Locations, Poland
Many Locations, Slovakia
Sponsors and Collaborators
Bang & Olufsen Medicom
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Regional Medical Affairs, Bayer Sp. z o.o. Identifier: NCT00470886     History of Changes
Obsolete Identifiers: NCT00458692
Other Study ID Numbers: 12827  KL0710PL  14237 - KL0710SK 
Study First Received: May 7, 2007
Last Updated: November 14, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on February 09, 2016