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Assessment of Compliance With Antihypertensive Telmisartan Therapy (COAST)

This study has been completed.
Sponsor:
Collaborator:
Bang & Olufsen Medicom
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00470886
First received: May 7, 2007
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Hypertension
 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:

Drug Information available for: Telmisartan
U.S. FDA Resources

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

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470886

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Regional Medical Affairs, Bayer Sp. z o.o.
ClinicalTrials.gov 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:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Telmisartan
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013