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

Tracking Information

First Received Date ^ICMJE

July 22, 2005

Last Updated Date

October 13, 2008

Start Date ^ICMJE

July 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Urine albumin:creatinine ratio

Original Primary Outcome Measures ^ICMJE

Urine albumin:creatinine ratio

Change History

Complete list of historical versions of study NCT00123903 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension
Microalbuminuria

Intervention ^ICMJE

Drug: metoprolol xl
Drug: carvedilol MR
Drug: lisinopril

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1220

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Puerto Rico

Administrative Information

NCT ID ^ICMJE

NCT00123903

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

COR103560

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP