- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00470886
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
Intervention / Treatment
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.
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
Additional Relevant MeSH Terms
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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