Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-03-01 @ 10:11 AM
Study NCT ID:
NCT00982735
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2009-09-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Telmisartan 40mg or Telmisartan 80 mg Once a Day', 'description': 'Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day', 'otherNumAtRisk': 757, 'otherNumAffected': 0, 'seriousNumAtRisk': 757, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '757', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 40mg or Telmisartan 80 mg Once a Day', 'description': 'Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day'}], 'classes': [{'categories': [{'measurements': [{'value': '711', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '757', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 40mg or Telmisartan 80 mg Once a Day', 'description': 'Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day'}], 'classes': [{'title': 'Marginal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Not satisfactory', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Outstanding', 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}]}]}, {'title': 'Very satisfactory', 'categories': [{'measurements': [{'value': '363', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'A 5-point scale was used by the attending physicians to assess the effectiveness of Telmisartan according to their opinion. The scale was rated from 0 (not satisfactory), 1 (marginal), 2 (satisfactory), 3 (very satisfactory) to 4 (outstanding).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Microalbuminuria at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '757', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 40mg or Telmisartan 80 mg Once a Day', 'description': 'Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day'}], 'classes': [{'title': 'No microalbuminuria at baseline (BL) and at week24', 'categories': [{'measurements': [{'value': '433', 'groupId': 'OG000'}]}]}, {'title': 'No microalbuminuria BL and 30 mg/g Crea at week24', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'No microalbuminuria BL and 100 mg/g Crea at week24', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No microalbuminuria BL and 500 mg/g Crea at week24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '30 mg/g Crea BL and no microalbuminuria at week24', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': '30mg/g Crea at BL and at week24', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': '30mg/g Crea at BL and 100mg/g Crea at week24', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '30mg/g Crea at BL and 500mg/g Crea at week24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '100 mg/g Crea BL and no microalbum.uria at week24', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': '100mg/g Crea at BL and 30mg/g Crea at week24', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': '100mg/g Crea at BL and at week24', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '100mg/g Crea at BL and 500mg/g Crea at week24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '500mg/g Crea at BL + no microalbuminuria at week24', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '500mg/g Crea at BL + 30mg/g Crea at week24', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '500mg/g Crea at BL and 100mg/g Crea at week24', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '500mg/g Crea at BL and at week24', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telmisartan 40mg or Telmisartan 80 mg Once a Day', 'description': 'Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '987'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '757'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Patient ineligible for trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '224'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Telmisartan 40mg or Telmisartan 80 mg Once a Day', 'description': 'Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.12', 'spread': '8.54', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '313', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '647', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Data with regards to gender is not available for 27 out of the total number of 987 participants.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 987}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-03-26', 'studyFirstSubmitDate': '2009-09-22', 'resultsFirstSubmitDate': '2010-02-09', 'studyFirstSubmitQcDate': '2009-09-22', 'lastUpdatePostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-11', 'studyFirstPostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion', 'timeFrame': '24 weeks', 'description': 'A 5-point scale was used by the attending physicians to assess the effectiveness of Telmisartan according to their opinion. The scale was rated from 0 (not satisfactory), 1 (marginal), 2 (satisfactory), 3 (very satisfactory) to 4 (outstanding).'}, {'measure': 'Change From Baseline in Microalbuminuria at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The "CONTROL" study is an out patient based prospective observational cohort study. The main aim of the study is to survey the safety and efficacy of Micardis 40 mg/day and 80 mg/day under real life conditions in usual clinical practice in essential hypertensive patients in the Kingdom of Saudi Arabia. The patients participating in the study will be surveyed for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Essential hypertensive patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female.\n* Aged 20 to 80 years old.\n* Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic BP \\> 140 mmHg but \\< 180 mmHg, and/or diastolic BP \\> 90 mmHg but \\< 110 mmHg).\n* Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication.\n\nExclusion Criteria:\n\n* Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert).\n* Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets.\n* Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.\n* Patients participating in any other protocol'}, 'identificationModule': {'nctId': 'NCT00982735', 'briefTitle': 'An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice.', 'orgStudyIdInfo': {'id': '502.540'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Boehringer Ingelheim, Study Chair', 'oldOrganization': 'Boehringer Ingelheim'}}}}