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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00471003
First Posted: May 8, 2007
Last Update Posted: January 20, 2010
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.
Information provided by:
Bayer
  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:


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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
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 ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: May 7, 2007
First Posted: May 8, 2007
Last Update Posted: January 20, 2010
Last Verified: January 2010

Keywords provided by Bayer:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action