Heart Failure, Congestive and Microalbuminuria
Conditions
Keywords
hypertension, urine albumin:creatinine ratio, microalbuminuria
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.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Persistent microalbuminuria.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy. | Baseline (Randomization Visit) and Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy. | 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 |
| Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment. | Baseline (Randomization Visit) and Month 6 |
Countries
Canada, Puerto Rico, United States
Outcome results
None listed