check_circleStudy Completed

Hypertension

Bayer Identifier:

12827

ClinicalTrials.gov Identifier:

NCT00470886

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of Compliance With Antihypertensive Telmisartan Therapy

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Age over 18
    - Untreated or ineffectively treated arterial hypertension
  • - 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
3400
Trial Dates
April 2007 - January 2010
Phase
N/A
Could I Receive a placebo
No
Products
Kinzal/Pritor (Telmisartan, BAY68-9291)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Poland
Completed
Many Locations, Slovakia

Primary Outcome

  • Efficacy and safety of the treatment with telmisartan reported by the physician with regard to usage the HelpingHand device
    date_rangeTime Frame:
    At all four planned control visits. (Approx. interval between visits 3 months)
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Compliance with the treatment calculated on the basis of by HelpingHand and patients questionnaires
    date_rangeTime Frame:
    At all four planned control visits. (Approx. interval between visits 3 months)
    enhanced_encryption
    Safety Issue:
    Yes

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
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.