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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:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00932867
First received: July 2, 2009
Last updated: April 19, 2010
Last verified: April 2010
History of Changes
  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:

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

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
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 spol.s.r.o.
ClinicalTrials.gov Identifier: NCT00932867     History of Changes
Other Study ID Numbers: 14010, 14010 - KL0711SK, 14327 - KL0711RO
Study First Received: July 2, 2009
Last Updated: April 19, 2010
Health Authority: Slovakia: State Institute for Drug Control

Keywords provided by Bayer:
Arterial Hypertension

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

ClinicalTrials.gov processed this record on May 16, 2013