Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-22 @ 10:19 PM
Study NCT ID:
NCT02242851
Status:
COMPLETED
Last Update Posted:
2014-09-17
First Post:
2014-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Describing the Hypertensive Population Treated With Telmisartan and Conditions of Use by Medical Practitioners and Patients
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': 5018}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-16', 'studyFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2014-09-16', 'lastUpdatePostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristics of hypertensive patients', 'timeFrame': 'Baseline, after 1 month of treatment', 'description': 'Questionnaire to determine the beneficiary population'}], 'secondaryOutcomes': [{'measure': 'Changes in blood pressure', 'timeFrame': 'Up to 1 month', 'description': 'Self-monitored by patient'}, {'measure': 'Evaluation of patients satisfaction with treatment', 'timeFrame': 'Up to 1 month', 'description': 'Based on a patient 6-point self-questionnaire'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': "Primary objective: to characterize hypertensive patients treated for at least 1 month with Telmisartan (alone or in combination with other drugs) in order to define the beneficiary population (those actually receiving the treatment).\n\nSecondary objectives:\n\n* to describe the patients' blood pressure values (when self-monitored) and satisfaction with the treatment (ease of use, efficacy, safety) on the basis of a patient self-questionnaire, filled out 4 weeks after consultation.\n* to compare the characteristics of the beneficiary population to those of the initial target population defined in the SPC (summary of product characteristics) for Telmisartan"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '94 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hypertensive patients treated with Telmisartan for at least one month recruited by ceneral practitioners and cardiologists', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertensive patients treated with Telmisartan for at least one month, consulting a medical practitioner (for whatever reason)\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT02242851', 'briefTitle': 'Study Describing the Hypertensive Population Treated With Telmisartan and Conditions of Use by Medical Practitioners and Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Pharmaco-epidemiological Study Describing the Hypertensive Population Treated With Telmisartan and Conditions of Use by Medical Practitioners and Patients', 'orgStudyIdInfo': {'id': '502.450'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypertensive patients', 'interventionNames': ['Drug: Telmisartan']}], 'interventions': [{'name': 'Telmisartan', 'type': 'DRUG', 'armGroupLabels': ['Hypertensive patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}