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

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.

First Received: July 2, 2009 Last Updated: July 16, 2009 History of Changes

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00932867

Purpose

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

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

Study Type:	Observational
Study Design:	Cohort, 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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Telmisartan

U.S. FDA Resources

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

Biospecimen Description:

Enrollment:	2000
Study Start Date:	December 2007
Study Completion Date:	June 2008
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 prod-uct 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

Slovakia

Many Location, Slovakia

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer spol.s.r.o. ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	14010, KL0711SK
Study First Received:	July 2, 2009
Last Updated:	July 16, 2009
ClinicalTrials.gov Identifier:	NCT00932867 History of Changes
Health Authority:	Slovakia: State Institute for Drug Control

Keywords provided by Bayer:

Arterial Hypertension

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Telmisartan

Angiotensin II
Protease Inhibitors
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors

Cardiovascular Diseases
Telmisartan
Pharmacologic Actions
Protease Inhibitors
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009