Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-26 @ 8:03 PM
Study NCT ID:
NCT00123903
Status:
TERMINATED
Last Update Posted:
2017-01-18
First Post:
2005-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria
Sponsor:
Organization:
Raw JSON
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'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1220}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-16', 'studyFirstSubmitDate': '2005-07-22', 'studyFirstSubmitQcDate': '2005-07-25', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy.', 'timeFrame': 'Baseline (Randomization Visit) and Month 6'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy.', 'timeFrame': 'Month 6'}, {'measure': 'Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy.', 'timeFrame': 'Month 6'}, {'measure': 'Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP)', 'timeFrame': 'Baseline (Randomization Visit) and Month 6'}, {'measure': 'Change from Pre-screening visit to month 6 LOCF in urine ACR.', 'timeFrame': 'Pre-screening Visit and Month 6'}, {'measure': 'Change from baseline to visit to month 6 LOCF in lipids including total cholesterol, low density lipid (LDL), high density lipid (HDL) and Triglycerides (TG)', 'timeFrame': 'Baseline (Randomization visit) and Month 6'}, {'measure': 'Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment.', 'timeFrame': 'Baseline (Randomization Visit) and Month 6'}, {'measure': 'Changes from baseline in heart rate at month 6 of treatment.', 'timeFrame': 'Baseline (Randomization visit) and Month 6'}, {'measure': 'Percentage of participants who required add-on therapy to reach target blood pressure at any time during the study.', 'timeFrame': 'Up to 6 months'}, {'measure': 'Number of participants with clinical chemistry parameters and hematology parameters of potential clinical concern at any time on-treatment.', 'timeFrame': 'Up to 6 months'}, {'measure': 'Number of participants with vital signs of potential clinical concern at any time on-treatment.', 'timeFrame': 'Up to 6 months'}]}, 'conditionsModule': {'keywords': ['hypertension', 'urine albumin:creatinine ratio', 'microalbuminuria'], 'conditions': ['Heart Failure, Congestive and Microalbuminuria']}, 'referencesModule': {'availIpds': [{'id': 'COR103560', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'COR103560', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'COR103560', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'COR103560', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'COR103560', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'COR103560', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'COR103560', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to determine whether COREG MR is more effective than TOPROL-XL in reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood pressure and microalbuminuria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Documented history of hypertension.\n* Must have been taking an ACE (angiotensin converting enzyme) inhibitor either alone or as part of an antihypertensive regimen for at least 8 weeks.\n* Persistent microalbuminuria.\n\nExclusion criteria:\n\n* History of heart attack, stroke, congestive heart failure, arrhythmia, type 1 or uncontrolled type 2 diabetes mellitus, liver or renal disease.\n* Has been taking any non-ocular beta-blockers for any indication within three months prior to Pre-screening.'}, 'identificationModule': {'nctId': 'NCT00123903', 'briefTitle': 'COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Double-blind, Positive-Controlled, Multicenter Study Comparing the Efficacy of Carvedilol Phosphate Modified Release Formulation (COREG MR) and Metoprolol Succinate Extended Release (TOPROL-XL) on the Reduction of Microalbuminuria in Patients With Hypertension and Microalbuminuria', 'orgStudyIdInfo': {'id': 'COR103560'}}, 'armsInterventionsModule': {'interventions': [{'name': 'metoprolol xl', 'type': 'DRUG'}, {'name': 'carvedilol MR', 'type': 'DRUG'}, {'name': 'lisinopril', 'type': 'DRUG', 'otherNames': ['carvedilol MR', 'metoprolol xl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35213', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': 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