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

July 2, 2009
April 19, 2010
December 2007
June 2008   (final data collection date for primary outcome measure)
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 ]
To evaluate efficacy and safety of telmisartan in patients with arterial hypertension, who do not tolerate ACEI treatment [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00932867 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment
Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment

Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension, who do not tolerate ACE inhibitoR treatment

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

n.a.

Non-Probability Sample
  • 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
Hypertension
Drug: Kinzal/Pritor (Telmisartan, BAY68-9291)
Patients under daily life treatment receiving Pritor according to local drug information.
Group 1
Intervention: Drug: Kinzal/Pritor (Telmisartan, BAY68-9291)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3114
August 2009
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania,   Slovakia
 
NCT00932867
14010, 14010 - KL0711SK, 14327 - KL0711RO
No
Medical Affairs Therapeutic Area Head, Bayer spol.s.r.o.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP