COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria
Phase 3
Terminated
- Conditions
- Heart Failure, Congestive and Microalbuminuria
- Registration Number
- NCT00123903
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1220
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy. Baseline (Randomization Visit) and Month 6
- Secondary Outcome Measures
Name Time Method Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy. Month 6 Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy. Month 6 Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP) Baseline (Randomization Visit) and Month 6 Change from Pre-screening visit to month 6 LOCF in urine ACR. 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) Baseline (Randomization visit) and Month 6 Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment. Baseline (Randomization Visit) and Month 6 Changes from baseline in heart rate at month 6 of treatment. 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. Up to 6 months Number of participants with clinical chemistry parameters and hematology parameters of potential clinical concern at any time on-treatment. Up to 6 months Number of participants with vital signs of potential clinical concern at any time on-treatment. Up to 6 months
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇷San Juan, Puerto Rico