Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT00471003
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2007-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension
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': 5448}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-19', 'studyFirstSubmitDate': '2007-05-07', 'studyFirstSubmitQcDate': '2007-05-07', 'lastUpdatePostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy and safety of the treatment with telmisartan reported by the physician', 'timeFrame': 'At the both of planned control visits. (Approx. interval between visits 3 months)'}], 'secondaryOutcomes': [{'measure': 'Changes in metabolic parameters in telmisartan treated patients', 'timeFrame': 'At the both of planned control visits. (Approx. interval between visits 3 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18\n* Untreated or ineffectively treated arterial hypertension\n\nExclusion Criteria:\n\n* Cholestatic disorders and severe hepatic failure\n* Allergy to telmisartan\n* Pregnancy and lactation period'}, 'identificationModule': {'nctId': 'NCT00471003', 'acronym': 'METABOLIC', 'briefTitle': 'The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension', 'nctIdAliases': ['NCT00459095'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Asses the Efficacy and Safety of Telmisartan, With the Special Attention on the Influence of Telmisartan on Selected Metabolic Parameters of Patients', 'orgStudyIdInfo': {'id': '12729'}, 'secondaryIdInfos': [{'id': 'KL0601PL'}, {'id': '13929 - KL0601SI'}, {'id': '12804 - KL0601SK'}, {'id': '14326 - KL0601HR'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1', 'interventionNames': ['Drug: Pritor (Telmisartan , BAY68-9291)']}], 'interventions': [{'name': 'Pritor (Telmisartan , BAY68-9291)', 'type': 'DRUG', 'description': 'Primary care hypertensive patients starting the therapy with Telmisartan', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Croatia'}, {'city': 'Many Locations', 'country': 'Poland'}, {'city': 'Many Locations', 'country': 'Slovakia'}, {'city': 'Many Locations', 'country': 'Slovenia'}], '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 Sp. z o.o'}}}}