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NCT00932867 Clinical Trial

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

Hypertension Clinical Trial

— SONAR  

Official title:
Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00932867
Other study ID # 14010
Secondary ID 14010 - KL0711SK
Status Completed
Phase N/A
First received July 2, 2009
Last updated April 19, 2010
Start date December 2007
Est. completion date August 2009

Study information
Verified date April 2010
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Slovakia: State Institute for Drug Control
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 3114
Est. completion date August 2009
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Romania,  Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate efficacy and safety of telmisartan in patients with arterial hypertension, who do not tolerate ACEI treatment 1 year Yes
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