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

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...

Date First Received: July 22, 2005

Last Updated: October 13, 2008

Verified by: GlaxoSmithKline, October 2008

Clinical Trial Phase: Phase 3 | Start Date: July 2005

Overall Status: Completed

Estimated Enrollment: 1220

Brief Summary

Official Title: “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”

Condition Keyword(s):

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

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: metoprolol xl
  • Drug: carvedilol MR
  • Drug: lisinopril

Outcome Measures for this Clinical Trial

Primary Measures

  • Urine albumin:creatinine ratio

Secondary Measures

  • Percentage of subjects who will progress to macroalbuminuria or revert to normoalbuminuria.
  • Lipid profile, C-reactive protein, blood pressure and heart rate.

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Additional Information

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00123903

Study ID Number: COR103560

ClinicalTrials.gov Identifier: NCT00123903

Health Authority: United States: Food and Drug Administration

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