Compliance With Antihypertensive Telmisartan Therapy - Full Text View

Sponsor:	Bayer
Collaborator:	Bang & Olufsen Medicom
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00470886

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:	Cohort, Prospective
Official Title:	A Non-Interventional, Post-Marketing Surveillance, Phase IV Study to Assess Compliance With Antihypertensive Telmisartan Therapy

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	5000
Study Start Date:	April 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (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

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Poland
	Recruiting
Many locations, Poland
Slovakia
	Recruiting
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

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Sp. z o.o. ( Medical Director )
Study ID Numbers:	12827, KL0710PL, KL0710SK, 14237
Study First Received:	May 7, 2007
Last Updated:	September 23, 2009
ClinicalTrials.gov Identifier:	NCT00470886 History of Changes
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United States: Food and Drug Administration

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

Angiotensin II Type 1 Receptor Blockers
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010