COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Heart Failure, Congestive and Microalbuminuria

Intervention / Treatment
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* Drug: metoprolol xl
* Drug: carvedilol MR
* Drug: lisinopril


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: metoprolol xl|nan|
|Drug: carvedilol MR|nan|
|Drug: lisinopril|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy. |  | Baseline (Randomization Visit) and Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, urine albumin:creatinine ratio, microalbuminuria