Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-04 @ 8:14 PM
Study NCT ID:
NCT02200094
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2014-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Micardis®. Observational Study in Patients With Essential 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': 4532}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-24', 'studyFirstSubmitDate': '2014-07-24', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in systolic and diastolic blood pressure', 'timeFrame': 'Baseline, 4 weeks and 3 months after start of treatment'}, {'measure': 'Percentage of patients with dose titration to 80 mg', 'timeFrame': '4 weeks and 3 months after start of treatment'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'Up to 3 months after start of treatment'}, {'measure': 'Global evaluation of treatment compliance by investigator, a 6-point rating scale', 'timeFrame': '4 weeks and 3 months after start of treatment'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study is designed to supplement, under conditions of usual clinical practice, the data on the efficacy and safety of Micardis® collected during the clinical studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients over 18 years of age suffering essential hypertension, treated by general practitioners and/or specialists', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of either sex over the age of 18 years suffering from essential hypertension requiring treatment according to the physician\n\nExclusion Criteria:\n\n* Hypersensitivity to the active component or to any of the excipients\n* Pregnancy and lactation\n* Biliary obstructive disorders\n* Severe hepatic impairment\n* Severe renal impairment'}, 'identificationModule': {'nctId': 'NCT02200094', 'briefTitle': 'Micardis®. Observational Study in Patients With Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Micardis®. Observational Study', 'orgStudyIdInfo': {'id': '502.361'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Outpatients with essential hypertension', 'interventionNames': ['Drug: Low dose of Telmisartan, once daily', 'Drug: High dose of Telmisartan, once daily']}], 'interventions': [{'name': 'Low dose of Telmisartan, once daily', 'type': 'DRUG', 'otherNames': ['Micardis®'], 'armGroupLabels': ['Outpatients with essential hypertension']}, {'name': 'High dose of Telmisartan, once daily', 'type': 'DRUG', 'otherNames': ['Micardis®'], 'armGroupLabels': ['Outpatients with essential hypertension']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}