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Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment (SONAR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00932867
First Posted: July 3, 2009
Last Update Posted: April 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
Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension, who do not tolerate ACE inhibitoR treatment

Condition Intervention
Hypertension Drug: Kinzal/Pritor (Telmisartan, BAY68-9291)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • To evaluate efficacy and safety of telmisartan in patients with arterial hypertension, who do not tolerate ACEI treatment [ Time Frame: 1 year ]

Biospecimen Retention:   None Retained
n.a.

Enrollment: 3114
Study Start Date: December 2007
Study Completion Date: August 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Kinzal/Pritor (Telmisartan, BAY68-9291)
Patients under daily life treatment receiving Pritor according to local drug information.

  Eligibility

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
  • Any patient with a diagnosis of arterial hypertension, who do not tolerated ACE inhibitor treatment treated by the drug PRITOR
  • Exclusion criteria for the patients treated by the drug PRITOR must be read in conjunction with the local product information
Criteria

Inclusion Criteria:

  • Patients over 18 years of age
  • Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg)
  • Patients, who do not tolerate ACE inhibitors (must be documented in the official ambulant documentation)

Inclusion criteria for the control arm (treated by ACEi):

  • Patients over 18 years of age
  • Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg)
  • Patients, who tolerate ACEi treatment

Exclusion Criteria:

  • Cholestasis, severe hepatic insufficiency
  • Allergy to telmisartan
  • Gravidity or lactation

Exclusion criteria for the arm of patient treated by ACEi:

  • Cholestasis, severe hepatic insufficiency
  • Allergy to ACEi
  • Gravidity or lactation
  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): NCT00932867


Locations
Romania
Many Locations, Romania
Slovakia
Many Location, Slovakia
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer spol.s.r.o.
ClinicalTrials.gov Identifier: NCT00932867     History of Changes
Other Study ID Numbers: 14010
14010 - KL0711SK
14327 - KL0711RO
First Submitted: July 2, 2009
First Posted: July 3, 2009
Last Update Posted: April 20, 2010
Last Verified: April 2010

Keywords provided by Bayer:
Arterial Hypertension

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