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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,220
Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy.
Time frame: Baseline (Randomization Visit) and Month 6
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
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Fullerton, California, United States
GSK Investigational Site
Inglewood, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Mission Viejo, California, United States
GSK Investigational Site
Oakland, California, United States
GSK Investigational Site
Redondo Beach, California, United States
GSK Investigational Site
Colorado Springs, Colorado, United States
...and 84 more locations
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