Trial Condition(s):
Hypertension
Assessment of Compliance With Antihypertensive Telmisartan Therapy (COAST)
Bayer Identifier:
12827
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Poland | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovakia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Non-Interventional, Post-Marketing Surveillance, Phase IV Study to Assess Compliance With Antihypertensive Telmisartan Therapy
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Efficacy and safety of the treatment with telmisartan reported by the physician with regard to usage the HelpingHand deviceTimeframe: At all four planned control visits. (Approx. interval between visits 3 months)
Secondary Outcome
- Compliance with the treatment calculated on the basis of by HelpingHand and patients questionnairesTimeframe: At all four planned control visits. (Approx. interval between visits 3 months)
Additional Information
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