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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00932867 |
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Date of registration:
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02/07/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment
SONAR |
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Scientific title:
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Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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3114 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00932867 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Romania
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Slovakia
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: Kinzal/Pritor (Telmisartan, BAY68-9291)
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Primary Outcome(s)
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To evaluate efficacy and safety of telmisartan in patients with arterial hypertension, who do not tolerate ACEI treatment
[Time Frame: 1 year]
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Secondary ID(s)
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14010
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14010 - KL0711SK
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14327 - KL0711RO
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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