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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: May 7, 2007
Last updated: January 19, 2010
Last verified: January 2010
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:

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) ]

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) ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00471003

Many Locations, Croatia
Many Locations, Poland
Many Locations, Slovakia
Many Locations, Slovenia
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

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

Keywords provided by Bayer:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on July 26, 2017