Full Text View
Tabular View
No Study Results Posted
Related Studies
COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria
This study has been completed.
First Received: July 22, 2005   Last Updated: October 13, 2008   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00123903
  Purpose

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.


Condition Intervention Phase
Hypertension
Microalbuminuria
 Drug: metoprolol xl
Drug: carvedilol MR
Drug: lisinopril
 Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Urine and Urination
Drug Information available for: Metoprolol Metoprolol Tartrate Carvedilol Lisinopril Metoprolol succinate Metoprolol fumarate
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Urine albumin:creatinine ratio

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

Estimated Enrollment: 1220
Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123903

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35205
GSK Investigational Site
Mobile, Alabama, United States, 36617
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85023
United States, California
GSK Investigational Site
Mission Viejo, California, United States, 92691
GSK Investigational Site
Los Angeles, California, United States, 90057
GSK Investigational Site
Fullerton, California, United States, 92835
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80919
United States, Florida
GSK Investigational Site
Tampa, Florida, United States, 33614
GSK Investigational Site
Sarasota, Florida, United States, 34239
GSK Investigational Site
Miami, Florida, United States, 33169
GSK Investigational Site
Hollywood, Florida, United States, 33023
GSK Investigational Site
Miami, Florida, United States, 33156
United States, Georgia
GSK Investigational Site
Decatur, Georgia, United States, 30035
United States, Illinois
GSK Investigational Site
Melrose Park, Illinois, United States, 60160
GSK Investigational Site
Chicago, Illinois, United States, 60607
GSK Investigational Site
Chicago, Illinois, United States, 60612
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46250
GSK Investigational Site
Evansville, Indiana, United States, 47714
GSK Investigational Site
Elkhart, Indiana, United States, 46515
GSK Investigational Site
Avon, Indiana, United States, 46123
GSK Investigational Site
Evansville, Indiana, United States, 47713
United States, Louisiana
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
United States, Massachusetts
GSK Investigational Site
Worcester, Massachusetts, United States, 01608
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
United States, New Jersey
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14222
GSK Investigational Site
Kingston, New York, United States, 12401
GSK Investigational Site
Rochester, New York, United States, 14618
GSK Investigational Site
East Syracuse, New York, United States, 13057
GSK Investigational Site
Port Chester, New York, United States, 10573
GSK Investigational Site
Camillus, New York, United States, 13031
United States, North Carolina
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
GSK Investigational Site
Charlotte, North Carolina, United States, 28211
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44130
GSK Investigational Site
Kettering, Ohio, United States, 45429
United States, Pennsylvania
GSK Investigational Site
Beaver, Pennsylvania, United States, 15009
GSK Investigational Site
Havertown, Pennsylvania, United States, 19083
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19152
United States, South Carolina
GSK Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
GSK Investigational Site
Johnson City, Tennessee, United States, 37604
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Dallas, Texas, United States, 75390-9068
GSK Investigational Site
Midland, Texas, United States, 79705
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
Galveston, Texas, United States, 77555-0188
GSK Investigational Site
San Antonio, Texas, United States, 78216
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
GSK Investigational Site
Springfield, Virginia, United States, 22151
GSK Investigational Site
Burke, Virginia, United States, 22015
United States, Washington
GSK Investigational Site
Spokane, Washington, United States, 99206
GSK Investigational Site
Edmonds, Washington, United States, 98026
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T2E 7C5
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V7N 4M2
GSK Investigational Site
New Westminster, British Columbia, Canada, V3L 3W4
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3K 0Y8
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Newfoundland and Labrador
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0G 1G0
Canada, Ontario
GSK Investigational Site
Kitchener, Ontario, Canada, N2G 1N9
GSK Investigational Site
Brampton, Ontario, Canada, L6T 3J1
GSK Investigational Site
London, Ontario, Canada, N5W 6A2
GSK Investigational Site
Stoney Creek, Ontario, Canada, L8G 2V6
GSK Investigational Site
Hamilton, Ontario, Canada, L8L 5G8
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Canada, Prince Edward Island
GSK Investigational Site
Montague, Prince Edward Island, Canada, C0A 1R0
GSK Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 5Y9
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2K 4L5
GSK Investigational Site
Bonaventure, Quebec, Canada, G0C 1E0
GSK Investigational Site
Pointe-Claire, Quebec, Canada, H9R 4S3
GSK Investigational Site
Saint-Romuald, Quebec, Canada, G6W 5M6
GSK Investigational Site
Trois Rivieres, Quebec, Canada, G8T 7A1
GSK Investigational Site
Mirabel, Quebec, Canada, J7J 2K8
Puerto Rico
GSK Investigational Site
Rio Grande, Puerto Rico, 00745
GSK Investigational Site
San Juan, Puerto Rico, 00907
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: COR103560
Study First Received: July 22, 2005
Last Updated: October 13, 2008
ClinicalTrials.gov Identifier: NCT00123903     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
urine albumin:creatinine ratio
microalbuminuria
hypertension

Additional relevant MeSH terms:
Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Signs and Symptoms
Urologic Diseases
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Carvedilol
Sympatholytics
 Albuminuria
Urination Disorders
Lisinopril
Vascular Diseases
Enzyme Inhibitors
Adrenergic alpha-Antagonists
Cardiovascular Agents
Metoprolol
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Urological Manifestations
Proteinuria
Autonomic Agents

ClinicalTrials.gov processed this record on November 27, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services