The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension - Full Text View

The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension (METABOLIC)

This study is currently recruiting participants.

Verified by Bayer, April 2009

First Received: May 7, 2007 Last Updated: April 2, 2009 History of Changes

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00471003

Purpose

The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.

Condition	Intervention	Phase
Hypertension	Drug: Micardis (Telmisartan, BAY68-9291)	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Telmisartan

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Asses the Efficacy and Safety of Telmisartan, With the Special Attention on the Influence of Telmisartan on Selected Metabolic Parameters of Patients

Further study details as provided by Bayer:

Primary Outcome Measures:

Efficacy and safety of the treatment with telmisartan reported by the physician [ Time Frame: At the both of planned control visits. (Approx. interval between visits 3 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in metabolic parameters in telmisartan treated patients [ Time Frame: At the both of planned control visits. (Approx. interval between visits 3 months) ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	6250
Study Start Date:	September 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Arm 1	Drug: Micardis (Telmisartan, BAY68-9291) Primary care hypertensive patients starting the therapy 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471003

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Croatia
	Recruiting
Many Locations, Croatia
Poland
	Completed
Many Locations, Poland
Slovakia
	Completed
Many Locations, Slovakia
Slovenia
	Recruiting
Many Locations, Slovenia

Sponsors and Collaborators

Bayer

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 Affairs Therapeutic Area Head )
Study ID Numbers:	12729, KL0601PL, 13929 - KL0601SI, 12804 - KL0601SK, 14326 - KL0601HR
Study First Received:	May 7, 2007
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00471003 History of Changes
Health Authority:	Poland: Medical Devices and Biocidal Products; Slovakia: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Slovakia: State Institute for Drug Control; Croatia: Agency for Medicinal Product and Medical Devices; Croatia: Ethics Committee; Slovenia: Ethics Committee

Keywords provided by Bayer:

Hypertension

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Telmisartan

Angiotensin II
Protease Inhibitors
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors

Cardiovascular Diseases
Telmisartan
Pharmacologic Actions
Protease Inhibitors
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009