Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-25 @ 9:45 PM
Study NCT ID:
NCT02176850
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Efficacy of Micardis® 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': 19870}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2014-06-25', 'studyFirstSubmitQcDate': '2014-06-26', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Indicence of ulcera', 'timeFrame': 'Up to 6 months after start of study'}, {'measure': 'Incidence of gastrointestinal (GI) bleedings', 'timeFrame': 'Up to 6 months after start of study'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (GI-complaints inclusive)', 'timeFrame': 'Up to 6 months after start of study'}, {'measure': 'Change from baseline in office blood pressure', 'timeFrame': 'Up to 6 months after start of study'}, {'measure': 'Response rate', 'timeFrame': 'Up to 6 months after start of study', 'description': 'full response: reduction of diastolic blood pressure (DBP) by \\>= 10 mmHg or final DBP \\<= 90 mmHg overall response: reduction of DBP by \\>= 7mmHg or final DBP \\<= 90 mmHg'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This post-marketing surveillance study was designed to supplement under conditions of normal clinical practice the data on the safety, tolerability and efficacy of Micardis® collected during the clinical studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of general practioners, cardiologists and specialist in internal medicine in non-hospital practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes with essential hypertension and a minimum age of 18 years\n\nExclusion Criteria: (Not applicable)'}, 'identificationModule': {'nctId': 'NCT02176850', 'briefTitle': 'Safety, Tolerability and Efficacy of Micardis® in Patients With Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability and Efficacy of Micardis® (Telmisartan) in Patients With Essential Hypertension', 'orgStudyIdInfo': {'id': '502.314'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Micardis®', 'interventionNames': ['Drug: Micardis®']}], 'interventions': [{'name': 'Micardis®', 'type': 'DRUG', 'armGroupLabels': ['Micardis®']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}