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Assessment of Compliance With Antihypertensive Telmisartan Therapy (COAST)

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ClinicalTrials.gov Identifier: NCT00470886
Recruitment Status : Completed
First Posted : May 8, 2007
Last Update Posted : November 16, 2012
Sponsor:
Collaborator:
Bang & Olufsen Medicom
Information provided by:
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.

Condition or disease Intervention/treatment
Hypertension Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)

Study Type : Observational
Actual Enrollment : 3400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Interventional, Post-Marketing Surveillance, Phase IV Study to Assess Compliance With Antihypertensive Telmisartan Therapy
Study Start Date : April 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
Group 1 Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)
Primary care clinic hypertensive patients for whom physician decided to start the treatment with telmisartan



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470886


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

Additional Information:
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 ( Other Identifier: Company )
14237 - KL0710SK ( Other Identifier: Company )
First Posted: May 8, 2007    Key Record Dates
Last Update Posted: November 16, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action