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

April 19, 2010 updated by: Bayer
Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension, who do not tolerate ACE inhibitoR treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Kinzal/Pritor (Telmisartan, BAY68-9291)
Patients under daily life treatment receiving Pritor according to local drug information.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 2, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Estimate)

April 20, 2010

Last Update Submitted That Met QC Criteria

April 19, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14010
  • 14010 - KL0711SK
  • 14327 - KL0711RO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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