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
  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 ] [ 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:
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 April 23, 2014