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

NCT ID: NCT00123903

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-05-31

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.

Detailed Description

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Conditions

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Heart Failure, Congestive and Microalbuminuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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metoprolol xl

Intervention Type DRUG

carvedilol MR

Intervention Type DRUG

lisinopril

Intervention Type DRUG

Other Intervention Names

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carvedilol MR metoprolol xl

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Fullerton, California, United States

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Inglewood, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Oakland, California, United States

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Redondo Beach, California, United States

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Colorado Springs, Colorado, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Melrose Park, Illinois, United States

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Avon, Indiana, United States

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Elkhart, Indiana, United States

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Evansville, Indiana, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Lafayette, Louisiana, United States

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Ayer, Massachusetts, United States

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Worcester, Massachusetts, United States

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Las Vegas, Nevada, United States

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Voorhees Township, New Jersey, United States

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Buffalo, New York, United States

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Camillus, New York, United States

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East Syracuse, New York, United States

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Kingston, New York, United States

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Port Chester, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Kettering, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oregon City, Oregon, United States

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Beaver, Pennsylvania, United States

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Havertown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Reading, Pennsylvania, United States

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West Grove, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Greer, South Carolina, United States

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Orangeburg, South Carolina, United States

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Johnson City, Tennessee, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Burke, Virginia, United States

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Springfield, Virginia, United States

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Edmonds, Washington, United States

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Olympia, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Wenatchee, Washington, United States

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Calgary, Alberta, Canada

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New Westminster, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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Brampton, Ontario, Canada

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Hamilton, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Stoney Creek, Ontario, Canada

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Toronto, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Montague, Prince Edward Island, Canada

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Bonaventure, Quebec, Canada

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Mirabel, Quebec, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Saint Romuald, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Río Grande, Puerto Rico, Puerto Rico

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San Juan, Puerto Rico, Puerto Rico

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Countries

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United States Canada Puerto Rico

Study Documents

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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COR103560

Identifier Type: -

Identifier Source: org_study_id

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