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

Condition(s) targeted: Hypertension; Microalbuminuria

Intervention: metoprolol xl (Drug); carvedilol MR (Drug); lisinopril (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Urine albumin:creatinine ratio

Secondary outcome:

Percentage of subjects who will progress to macroalbuminuria or revert to normoalbuminuria.

Lipid profile, C-reactive protein, blood pressure and heart rate.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

GSK Clinical Trials Call Center, San Juan 00921, Puerto Rico

GSK Clinical Trials Call Center, Rio Grande 00745, Puerto Rico

GSK Clinical Trials Call Center, San Juan 00922, Puerto Rico

GSK Clinical Trials Call Center, San Juan 00907, Puerto Rico

GSK Clinical Trials Call Center, Mobile, Alabama 36617, United States

GSK Clinical Trials Call Center, Birmingham, Alabama 35233, United States

GSK Clinical Trials Call Center, Birmingham, Alabama 35209, United States

GSK Clinical Trials Call Center, Calgary, Alberta T2E 7C5, Canada

GSK Clinical Trials Call Center, Phoenix, Arizona 85023, United States

GSK Clinical Trials Call Center, Phoenix, Arizona 85020, United States

GSK Clinical Trials Call Center, New Westminster, British Columbia V3L 3W4, Canada

GSK Clinical Trials Call Center, Vancouver, British Columbia V7N 4M2, Canada

GSK Clinical Trials Call Center, Fullerton, California 92835, United States

GSK Clinical Trials Call Center, Orange, California 92868, United States

GSK Clinical Trials Call Center, Oakland, California 94609, United States

GSK Clinical Trials Call Center, Mission Viejo, California 92691, United States

GSK Clinical Trials Call Center, Redondo Beach, California 90277, United States

GSK Clinical Trials Call Center, Inglewood, California 90301, United States

GSK Clinical Trials Call Center, Los Angeles, California 90057, United States

GSK Clinical Trials Call Center, Colorado Springs, Colorado 80907, United States

GSK Clinical Trials Call Center, Sarasota, Florida 342339, United States

GSK Clinical Trials Call Center, Miami, Florida 33169, United States

GSK Clinical Trials Call Center, Pembroke Pines, Florida 33024, United States

GSK Clinical Trials Call Center, Tampa, Florida 33614, United States

GSK Clinical Trials Call Center, Hollywood, Florida 33023, United States

GSK Clinical Trials Call Center, Miami, Florida 33156, United States

GSK Clinical Trials Call Center, Miami, Florida 33156, United States

GSK Clinical Trials Call Center, Atlanta, Georgia 30308, United States

GSK Clinical Trials Call Center, Decatur, Georgia 30035, United States

GSK Clinical Trials Call Center, Atlanta, Georgia 30308, United States

GSK Clinical Trials Call Center, Marietta, Georgia 30066, United States

GSK Clinical Trials Call Center, Hayden Lake, Idaho 83835, United States

GSK Clinical Trials Call Center, Chicago, Illinois 60612, United States

GSK Clinical Trials Call Center, Melrose Park, Illinois 60160, United States

GSK Clinical Trials Call Center, Chicago, Illinois 60607, United States

GSK Clinical Trials Call Center, Evansville, Indiana 47714, United States

GSK Clinical Trials Call Center, Avon, Indiana 46123, United States

GSK Clinical Trials Call Center, Newburgh, Indiana 47630, United States

GSK Clinical Trials Call Center, Indianapolis, Indiana 46250, United States

GSK Clinical Trials Call Center, Elkhart, Indiana 46514, United States

GSK Clinical Trials Call Center, Evansville, Indiana 47713, United States

GSK Clinical Trials Call Center, Indianapolis, Indiana 46524, United States

GSK Clinical Trials Call Center, Iowa City, Iowa 52242, United States

GSK Clinical Trials Call Center, Lafayette, Louisiana 70503, United States

GSK Clinical Trials Call Center, New Orleans, Louisiana 70117, United States

GSK Clinical Trials Call Center, Auburn, Maine 04210, United States

GSK Clinical Trials Call Center, Rockland, Maine 04841, United States

GSK Clinical Trials Call Center, Winnipeg, Manitoba R3K 0Y8, Canada

GSK Clinical Trials Call Center, Winnipeg, Manitoba R3E 3P4, Canada

GSK Clinical Trials Call Center, Ayer, Massachusetts 01432, United States

GSK Clinical Trials Call Center, Worcester, Massachusetts 01608, United States

GSK Clinical Trials Call Center, Detroit, Michigan 48201, United States

GSK Clinical Trials Call Center, Olive Branch, Mississippi 38654, United States

GSK Clinical Trials Call Center, St. Louis, Missouri 63110, United States

GSK Clinical Trials Call Center, Columbia, Montana 65212, United States

GSK Clinical Trials Call Center, Las Vegas, Nevada 89119, United States

GSK Clinical Trials Call Center, Princeton, New Jersey 08540, United States

GSK Clinical Trials Call Center, Voorhees, New Jersey 08043, United States

GSK Clinical Trials Call Center, Albuquerque, New Mexico 87131, United States

GSK Clinical Trials Call Center, West Seneca, New York 14224, United States

GSK Clinical Trials Call Center, Tonawanda, New York 14150, United States

GSK Clinical Trials Call Center, East Syracuse, New York 13057, United States

GSK Clinical Trials Call Center, New York, New York 10032, United States

GSK Clinical Trials Call Center, Johnson City, New York 13790, United States

GSK Clinical Trials Call Center, Kingston, New York 12401, United States

GSK Clinical Trials Call Center, Camillus, New York 13031, United States

GSK Clinical Trials Call Center, Rochester, New York 14618, United States

GSK Clinical Trials Call Center, Endwell, New York 13760, United States

GSK Clinical Trials Call Center, Bay Roberts, Newfoundland and Labrador A0G 1G0, Canada

GSK Clinical Trials Call Center, Charlotte, North Carolina 28211, United States

GSK Clinical Trials Call Center, Greensboro, North Carolina 27401, United States

GSK Clinical Trials Call Center, Greenville, North Carolina 27834, United States

GSK Clinical Trials Call Center, Raleigh, North Carolina 27609, United States

GSK Clinical Trials Call Center, Winston-Salem, North Carolina 27103, United States

GSK Clinical Trials Call Center, Dayton, Ohio 45402, United States

GSK Clinical Trials Call Center, Cleveland, Ohio 44195, United States

GSK Clinical Trials Call Center, Columbus, Ohio 43210, United States

GSK Clinical Trials Call Center, Middleburg Heights, Ohio 44130, United States

GSK Clinical Trials Call Center, Kettering, Ohio 45429, United States

GSK Clinical Trials Call Center, Canton, Ohio 44716, United States

GSK Clinical Trials Call Center, Oklahoma City, Oklahoma 73112, United States

GSK Clinical Trials Call Center, Stoney Creek, Ontario L8G 2V6, Canada

GSK Clinical Trials Call Center, Hamilton, Ontario L8L 5G8, Canada

GSK Clinical Trials Call Center, Toronto, Ontario M9W 4L6, Canada

GSK Clinical Trials Call Center, Brampton, Ontario L6T 3T1, Canada

GSK Clinical Trials Call Center, London, Ontario N5W 6A2, Canada

GSK Clinical Trials Call Center, Kitchener, Ontario N2G 1G5, Canada

GSK Clinical Trials Call Center, Oregon City, Oregon 97045, United States

GSK Clinical Trials Call Center, Beaver, Pennsylvania 15009, United States

GSK Clinical Trials Call Center, Havertown, Pennsylvania 19083, United States

GSK Clinical Trials Call Center, Reading, Pennsylvania 19601, United States

GSK Clinical Trials Call Center, Allentown, Pennsylvania 18102, United States

GSK Clinical Trials Call Center, West Grove, Pennsylvania 19390, United States

GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19152, United States

GSK Clinical Trials Call Center, Montague, Prince Edward Island C0A 1R0, Canada

GSK Clinical Trials Call Center, Charlottetown, Prince Edward Island C1A 5Y9, Canada

GSK Clinical Trials Call Center, Sainte Romuald, Quebec G6W 5M6, Canada

GSK Clinical Trials Call Center, Trois Rivieres, Quebec G8T 7A1, Canada

GSK Clinical Trials Call Center, St-Jerome, Quebec J7Z 5T3, Canada

GSK Clinical Trials Call Center, Bonaventure, Quebec G0C 1E0, Canada

GSK Clinical Trials Call Center, Montreal, Quebec H2K 4L5, Canada

GSK Clinical Trials Call Center, Pointe Claire, Quebec H9R 4S3, Canada

GSK Clinical Trials Call Center, East Providence, Rhode Island 02914, United States

GSK Clinical Trials Call Center, Greer, South Carolina 29651, United States

GSK Clinical Trials Call Center, Orangeburg, South Carolina 29118, United States

GSK Clinical Trials Call Center, Moncks Corner, South Carolina 29461, United States

GSK Clinical Trials Call Center, Charleston, South Carolina 29425, United States

GSK Clinical Trials Call Center, Johnson City, Tennessee 37604, United States

GSK Clinical Trials Call Center, Dallas, Texas 75390, United States

GSK Clinical Trials Call Center, Midland, Texas 79705, United States

GSK Clinical Trials Call Center, Galveston, Texas 77555, United States

GSK Clinical Trials Call Center, Houston, Texas 77024, United States

GSK Clinical Trials Call Center, Fort Worth, Texas 76104, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States

GSK Clinical Trials Call Center, Dallas, Texas 75390, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78216, United States

GSK Clinical Trials Call Center, Dallas, Texas 75231, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States

GSK Clinical Trials Call Center, Beaumont, Texas 77701, United States

GSK Clinical Trials Call Center, Amarillo, Texas 79106, United States

GSK Clinical Trials Call Center, Houston, Texas 77030, United States

GSK Clinical Trials Call Center, Salt Lake City, Utah 84121, United States

GSK Clinical Trials Call Center, Salt Lake City, Utah 84109, United States

GSK Clinical Trials Call Center, Springfield, Virginia 22151, United States

GSK Clinical Trials Call Center, Burke, Virginia 22015, United States

GSK Clinical Trials Call Center, Burke, Virginia 22015, United States

GSK Clinical Trials Call Center, Edmonds, Washington 98026, United States

GSK Clinical Trials Call Center, Spokane, Washington 99208, United States

GSK Clinical Trials Call Center, Olympia, Washington 98502, United States

GSK Clinical Trials Call Center, Spokane, Washington 99207, United States

GSK Clinical Trials Call Center, Monroe, Washington 98272, United States

GSK Clinical Trials Call Center, Wenatchee, Washington 98801, United States

GSK Clinical Trials Call Center, Spokane, Washington 99206, United States

Starting date: July 2005
Last updated: September 6, 2006