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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00471003
First received: May 7, 2007
Last updated: January 19, 2010
Last verified: January 2010
History of Changes
  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
Hypertension
 Drug: Pritor (Telmisartan , BAY68-9291)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:

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 [ 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 ]

Enrollment: 5448
Study Start Date: September 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm 1 Drug: Pritor (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

Locations
Croatia
Many Locations, Croatia
Poland
Many Locations, Poland
Slovakia
Many Locations, Slovakia
Slovenia
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

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Sp. z o.o
ClinicalTrials.gov Identifier: NCT00471003     History of Changes
Obsolete Identifiers: NCT00459095
Other Study ID Numbers: 12729, KL0601PL, 13929 - KL0601SI, 12804 - KL0601SK, 14326 - KL0601HR
Study First Received: May 7, 2007
Last Updated: January 19, 2010
Health Authority: 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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Benzoates
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013