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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00932867
• Collaborator: (none)
• Enrollment: 3,114
• Locations: 2
• Duration (Months): 20
• Patients Per Site: 1557
• Patients Per Site Per Month: 77.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Kinzal/Pritor (Telmisartan, BAY68-9291)

Study Design

• Study Type: Observational
• Actual Enrollment: 3114 participants
• 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
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To evaluate efficacy and safety of telmisartan in patients with arterial hypertension, who do not tolerate ACEI treatment [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Romania
2		Many Location		Slovakia

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00932867
• Other Study ID Numbers: 14010; 14010 - KL0711SK; 14327 - KL0711RO
• First Posted: Jul 3, 2009
• Last Update Posted: Apr 20, 2010
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Arterial Hypertension
• Additional relevant MeSH terms: Hypertension; Telmisartan

Study Results

No Results Posted as of Apr 20, 2010