Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-28 @ 6:33 PM
Study NCT ID:
NCT00932867
Status:
COMPLETED
Last Update Posted:
2010-04-20
First Post:
2009-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-19', 'studyFirstSubmitDate': '2009-07-02', 'studyFirstSubmitQcDate': '2009-07-02', 'lastUpdatePostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate efficacy and safety of telmisartan in patients with arterial hypertension, who do not tolerate ACEI treatment', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arterial Hypertension'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension, who do not tolerate ACE inhibitoR treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Any patient with a diagnosis of arterial hypertension, who do not tolerated ACE inhibitor treatment treated by the drug PRITOR\n* Exclusion criteria for the patients treated by the drug PRITOR must be read in conjunction with the local product information', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age\n* Arterial hypertension (SBP \\< 160 mmHg and DBP \\< 100 mmHg)\n* Patients, who do not tolerate ACE inhibitors (must be documented in the official ambulant documentation)\n\nInclusion criteria for the control arm (treated by ACEi):\n\n* Patients over 18 years of age\n* Arterial hypertension (SBP \\< 160 mmHg and DBP \\< 100 mmHg)\n* Patients, who tolerate ACEi treatment\n\nExclusion Criteria:\n\n* Cholestasis, severe hepatic insufficiency\n* Allergy to telmisartan\n* Gravidity or lactation\n\nExclusion criteria for the arm of patient treated by ACEi:\n\n* Cholestasis, severe hepatic insufficiency\n* Allergy to ACEi\n* Gravidity or lactation'}, 'identificationModule': {'nctId': 'NCT00932867', 'acronym': 'SONAR', 'briefTitle': 'Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment', 'orgStudyIdInfo': {'id': '14010'}, 'secondaryIdInfos': [{'id': '14010 - KL0711SK'}, {'id': '14327 - KL0711RO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Kinzal/Pritor (Telmisartan, BAY68-9291)']}], 'interventions': [{'name': 'Kinzal/Pritor (Telmisartan, BAY68-9291)', 'type': 'DRUG', 'description': 'Patients under daily life treatment receiving Pritor according to local drug information.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Romania'}, {'city': 'Many Location', 'country': 'Slovakia'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Therapeutic Area Head', 'oldOrganization': 'Bayer spol.s.r.o.'}}}}