Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-30 @ 6:04 PM
Study NCT ID:
NCT00123604
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2005-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}, {'id': 'D008790', 'term': 'Metoprolol'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kelly105@umn.edu', 'phone': '612-626-3492', 'title': 'Aaron S. Kelly, Ph.D.', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The sample size was relatively small'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Metoprolol', 'description': 'Metoprolol, orally, 200mg, once daily', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Carvedilol', 'description': 'Carvedilol, orally, 25 mg, once daily', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Flow Mediated Dilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carvedilol', 'description': 'Carvedilol, orally, 25mg, once daily'}, {'id': 'OG001', 'title': 'Metoprolol', 'description': 'Metoprolol, orally, 200mg, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change from baseline to 5 months', 'description': 'Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.', 'unitOfMeasure': 'percentage of change in dilation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metoprolol', 'description': 'Metoprolol, orally, 200 mg, once daily'}, {'id': 'FG001', 'title': 'Carvedilol', 'description': 'Carvedilol, orally, 25 mg, once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment occured at medical clinics.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Metoprolol', 'description': 'Metoprolol, orally, 200mg, twice daily for five months'}, {'id': 'BG001', 'title': 'Carvedilol', 'description': 'Carvedilol, orally, 25mg, twice daily for five months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-17', 'studyFirstSubmitDate': '2005-07-21', 'resultsFirstSubmitDate': '2012-06-29', 'studyFirstSubmitQcDate': '2005-07-21', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-17', 'studyFirstPostDateStruct': {'date': '2005-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow Mediated Dilation', 'timeFrame': 'change from baseline to 5 months', 'description': 'Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['beta-blockers', 'endothelial function'], 'conditions': ['Hypertension', 'Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '17586413', 'type': 'DERIVED', 'citation': 'Bank AJ, Kelly AS, Thelen AM, Kaiser DR, Gonzalez-Campoy JM. Effects of carvedilol versus metoprolol on endothelial function and oxidative stress in patients with type 2 diabetes mellitus. Am J Hypertens. 2007 Jul;20(7):777-83. doi: 10.1016/j.amjhyper.2007.01.019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.', 'detailedDescription': 'Carvedilol and metoprolol are two commonly used blood pressure medications that have both been shown to be effective in controlling hypertension. Although in the same drug class, preliminary data have shown that these medications may have different vascular effects. This study will assess which medication is better at improving artery health independent of their blood pressure lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30-80 years old\n* Documented history of type 2 diabetes\n* Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30 days before and throughout the study period\n* Stable anti-diabetic regimen throughout the study period\n* Body mass index (BMI) between 22-45 kg/m2\n* HbA1c between 6-9% for patients on anti-diabetic treatment regimen and HbA1c between 6-8% for patients who are being controlled by diet alone\n* Screening blood pressure (BP) \\> 130/80 (average of 3 sitting measurements), with current medications\n\nExclusion Criteria:\n\n* Uncontrollable or symptomatic arrhythmias\n* Unstable angina\n* Sick sinus syndrome or second or third degree heart block\n* Decompensated heart failure\n* Myocardial infarction (MI) or stroke within 3 months of screening\n* Bradycardia\n* Chronic obstructive pulmonary disease (COPD) with required inhaled or oral bronchodilators or corticosteroids\n* Bronchial asthma or related bronchospastic conditions\n* New onset/diagnosed type 2 diabetes (\\<3 months)\n* Clinically significant renal or liver disease (creatinine \\>2.5 mg/dL)\n* Endocrine disorders\n* Use of anorectic or other diet drugs inconsistent with recommendations for type 2 diabetics\n* Use of beta-blockers within 3 months of screening\n* Use of corticosteroids\n* Systemic disease, including cancer, with reduced life expectancy (\\<12 months)\n* Psychological illness/condition that interferes with comprehension of study requirements\n* Use of an investigational drug within 30 days of entry into study'}, 'identificationModule': {'nctId': 'NCT00123604', 'briefTitle': 'Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'St. Paul Heart Clinic'}, 'officialTitle': 'Effects of Carvedilol and Metoprolol on Endothelial Function in Hypertensive Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'GSK101598'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carvedilol', 'description': 'Carvedilol, orally, 25 mg, twice daily for five months', 'interventionNames': ['Drug: Carvedilol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metoprolol', 'description': 'Metoprolol, orally, 200 mg, twice daily for five months.', 'interventionNames': ['Drug: Metoprolol']}], 'interventions': [{'name': 'Carvedilol', 'type': 'DRUG', 'otherNames': ['Coreg'], 'description': '25 mg twice daily for five months.', 'armGroupLabels': ['Carvedilol']}, {'name': 'Metoprolol', 'type': 'DRUG', 'otherNames': ['Lopressor'], 'description': '200 mg twice daily for five months.', 'armGroupLabels': ['Metoprolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'St. Paul Heart Clinic', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Alan J Bank, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Paul Heart Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Paul Heart Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Scientist', 'investigatorFullName': 'Aaron S. Kelly, Ph.D.', 'investigatorAffiliation': 'St. Paul Heart Clinic'}}}}