COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria
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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.
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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy. [ Time Frame: Baseline (Randomization Visit) and Month 6 ]
Secondary Outcome Measures :
Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy. [ Time Frame: Month 6 ]
Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy. [ Time Frame: Month 6 ]
Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP) [ Time Frame: Baseline (Randomization Visit) and Month 6 ]
Change from Pre-screening visit to month 6 LOCF in urine ACR. [ Time Frame: Pre-screening Visit and Month 6 ]
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) [ Time Frame: Baseline (Randomization visit) and Month 6 ]
Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment. [ Time Frame: Baseline (Randomization Visit) and Month 6 ]
Changes from baseline in heart rate at month 6 of treatment. [ Time Frame: Baseline (Randomization visit) and Month 6 ]
Percentage of participants who required add-on therapy to reach target blood pressure at any time during the study. [ Time Frame: Up to 6 months ]
Number of participants with clinical chemistry parameters and hematology parameters of potential clinical concern at any time on-treatment. [ Time Frame: Up to 6 months ]
Number of participants with vital signs of potential clinical concern at any time on-treatment. [ Time Frame: Up to 6 months ]
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Documented history of hypertension.
Must have been taking an ACE (angiotensin converting enzyme) inhibitor either alone or as part of an antihypertensive regimen for at least 8 weeks.
History of heart attack, stroke, congestive heart failure, arrhythmia, type 1 or uncontrolled type 2 diabetes mellitus, liver or renal disease.
Has been taking any non-ocular beta-blockers for any indication within three months prior to Pre-screening.