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

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-22
• Study First Submitted QC: 2005-07-25
• Study First Posted: 2005-07-26
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

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