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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00471003
Recruitment Status : Completed
First Posted : May 8, 2007
Last Update Posted : January 20, 2010
Information provided by:

Brief Summary:
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 or disease Intervention/treatment
Hypertension Drug: Pritor (Telmisartan , BAY68-9291)

Study Type : Observational
Actual Enrollment : 5448 participants
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
Study Start Date : September 2006
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan
U.S. FDA Resources

Group/Cohort Intervention/treatment
Arm 1 Drug: Pritor (Telmisartan , BAY68-9291)
Primary care hypertensive patients starting the therapy with Telmisartan

Primary Outcome Measures :
  1. 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 :
  1. Changes in metabolic parameters in telmisartan treated patients [ Time Frame: At the both of planned control visits. (Approx. interval between visits 3 months) ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00471003

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

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
First Posted: May 8, 2007    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: January 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