The purpose of this study is 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 Albuminuria	Drug: metoprolol XL  Drug: Carvedilol MR  Drug: lisinopril	Phase III

Further Study Details: 

Primary Outcomes: Urine albumin:creatinine ratio
Secondary Outcomes: Percentage of subjects who will progress to macroalbuminuria or revert to normoalbuminuria. Lipid profile, C-reactive protein, blood pressure and heart rate.
Expected Total Enrollment:  1220

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00123903

Alabama
      Raymond Bell, Mobile,  Alabama,  36617,  United States
      Rafael Coplin, Birmingham,  Alabama,  35233,  United States
Arizona
      Martin Mollen, Phoenix,  Arizona,  85023,  United States
California
      John Gilbert, Fullerton,  California,  92835,  United States
      Andrew Lewin, Los Angeles,  California,  90057,  United States
      Samuel Mayeda, Orange,  California,  92868,  United States
      Robert Scott, Oakland,  California,  94609,  United States
      Cranford Scott, Inglewood,  California,  90301,  United States
      Joseph Barrera, Mission Viejo,  California,  92691,  United States
      Bruce Jackson, Redondo Beach,  California,  90277,  United States
Colorado
      John Speer, Colorado Springs,  Colorado,  80907,  United States
Florida
      Mahfouz El Shahawy, Sarasota,  Florida,  342339,  United States
      Ernesto Fuentes, Miami,  Florida,  33169,  United States
      Pamela Stearns, Pembroke Pines,  Florida,  33024,  United States
      Edward Braun, Tampa,  Florida,  33614,  United States
      Gregory Serfer, Hollywood,  Florida,  33023,  United States
      Peter Weissman, Miami,  Florida,  33156,  United States
      Cristian Breton, Miami,  Florida,  33156,  United States
Georgia
      Joseph Martin, Atlanta,  Georgia,  30308,  United States
      William McGarity, Decatur,  Georgia,  30035,  United States
Idaho
      Terrance Riske, Hayden Lake,  Idaho,  83835,  United States
Illinois
      George Bakris, Chicago,  Illinois,  60612,  United States
      Jeffrey Shanes, Melrose Park,  Illinois,  60160,  United States
      Danny Sugimoto, Chicago,  Illinois,  60607,  United States
Indiana
      Mohammed Allaw, Evansville,  Indiana,  47714,  United States
      Ronald Stegemoller, Avon,  Indiana,  46123,  United States
      Gary Erdy, Newburgh,  Indiana,  47630,  United States
      Rashid Khairi, Indianapolis,  Indiana,  46250,  United States
      George Mark, Elkhart,  Indiana,  46514,  United States
      Andrew Thieneman, Evansville,  Indiana,  47713,  United States
      Thomas Wade, Indianapolis,  Indiana,  46524,  United States
Iowa
      Jenniifer Robinson, Iowa City,  Iowa,  52242,  United States
Louisiana
      Ruth Smothers, Lafayette,  Louisiana,  70503,  United States
      Keith Ferdinand, New Orleans,  Louisiana,  70117,  United States
Maine
      Beth Kester, Rockland,  Maine,  04841,  United States
      Robert Weiss, Auburn,  Maine,  04210,  United States
Massachusetts
      Terrance Hack, Ayer,  Massachusetts,  01432,  United States
      Gary Noroian, Worcester,  Massachusetts,  01608,  United States
Missouri
      Janet McGill, St. Louis,  Missouri,  63110,  United States
Montana
      David Gardner, Columbia,  Montana,  65212,  United States
Nevada
      V. Jerome Mirkil, Las Vegas,  Nevada,  89119,  United States
New Jersey
      Ryan McCormick, Voorhees,  New Jersey,  08043,  United States
      Rupa Mongia, Princeton,  New Jersey,  08540,  United States
New Mexico
      Mark Burge, Albuquerque,  New Mexico,  87131,  United States
New York
      Brian Snyder, West Seneca,  New York,  14224,  United States
      Richard Castaldo, Tonawanda,  New York,  14150,  United States
      Peter Christiano, East Syracuse,  New York,  13057,  United States
      Daniel Donovan, New York,  New York,  10032,  United States
      Frank Eder, Johnson City,  New York,  13790,  United States
      Amin Elashker, Kingston,  New York,  12401,  United States
      James Lawless, Camillus,  New York,  13031,  United States
      William Stein, Rochester,  New York,  14618,  United States
      James Holler, Endwell,  New York,  13760,  United States
North Carolina
      Matthew Acampora, Charlotte,  North Carolina,  28211,  United States
      Amy Stevenson, Greensboro,  North Carolina,  27401,  United States
      Robert Tanenberg, Greenville,  North Carolina,  27834,  United States
      James Coxe, Raleigh,  North Carolina,  27609,  United States
      John Card, Winston Salem,  North Carolina,  27103,  United States
Ohio
      Morris Brown, Dayton,  Ohio,  45402,  United States
      Byron Hoogwerf, Cleveland,  Ohio,  44195,  United States
      Kwame Osei, Columbus,  Ohio,  43210,  United States
      Robert Blankfield, Middleburg Heights,  Ohio,  44130,  United States
      Naynesh Patel, Kettering,  Ohio,  45429,  United States
      Frederick Whittier, Canton,  Ohio,  44716,  United States
Oklahoma
      Donald Denmark, Oklahoma City,  Oklahoma,  73112,  United States
Oregon
      J. Thomas Forsythe, Oregon City,  Oregon,  97045,  United States
Pennsylvania
      Angel Flores, Beaver,  Pennsylvania,  15009,  United States
      Ronald Fuchs, Havertown,  Pennsylvania,  19083,  United States
      Joseph Kang, Reading,  Pennsylvania,  19601,  United States
      Ata Motamedi, Allentown,  Pennsylvania,  18102,  United States
      Deepak Santram, West Grove,  Pennsylvania,  19390,  United States
      Gary Yeoman, Philadelphia,  Pennsylvania,  19152,  United States
Rhode Island
      Ronald Gilman, East Providence,  Rhode Island,  02914,  United States
South Carolina
      Phillip Snell, Greer,  South Carolina,  29651,  United States
      Charles Raine, Orangeburg,  South Carolina,  29118,  United States
      Rose Gibbs, Moncks Corner,  South Carolina,  29461,  United States
Tennessee
      Richard McDavid, Johnson City,  Tennessee,  37604,  United States
Texas
      Kathleen Wyne, Dallas,  Texas,  75390,  United States
      GM Gollapudi, Midland,  Texas,  79705,  United States
      Jamal Islam, Galveston,  Texas,  77555,  United States
      Clark McKeever, Houston,  Texas,  77024,  United States
      Carlos Mijares, Fort Worth,  Texas,  76104,  United States
      Geri Poss, San Antonio,  Texas,  78229,  United States
      Philip Raskin, Dallas,  Texas,  75390,  United States
      Tamyra Rogers, San Antonio,  Texas,  78216,  United States
      Richard Sachson, Dallas,  Texas,  75231,  United States
      Sherwyn Schwartz, San Antonio,  Texas,  78229,  United States
      Eric Marks, Beaumont,  Texas,  77701,  United States
      Ernesto Rivera, Amarillo,  Texas,  79106,  United States
Utah
      Shane Christensen, Salt Lake City,  Utah,  84121,  United States
      Dan Henry, Salt Lake City,  Utah,  84109,  United States
Virginia
      Mrinal Sharma, Springfield,  Virginia,  22151,  United States
      Puneet Narayan, Burke,  Virginia,  22015,  United States
      Stuart Henocowicz, Burke,  Virginia,  22015,  United States
Washington
      Robert Bettis, Edmonds,  Washington,  98026,  United States
      Timothy Gardner, Spokane,  Washington,  99208,  United States
      Eric Klein, Olympia,  Washington,  98502,  United States
      Joseph Phaneuf, Spokane,  Washington,  99207,  United States
      Jeff Hambleton, Monroe,  Washington,  98272,  United States
      James Cook, Wenatchee,  Washington,  98801,  United States
      Michael Kerkering, Spokane,  Washington,  99206,  United States
Canada, Alberta
      GSK Clinical Trials Call Center, Calgary,  Alberta,  T2E 7C5,  Canada
Canada, British Columbia
      GSK Clinical Trials Call Center, New Westminster,  British Columbia,  V3L 3W4,  Canada
      GSK Clinical Trials Call Center, Vancouver,  British Columbia,  V7N 4M2,  Canada
Canada, Manitoba
      GSK Clinical Trials Call Center, Winnipeg,  Manitoba,  R3K 0Y8,  Canada
      GSK Clinical Trials Call Center, Winnipeg,  Manitoba,  R3E 3P4,  Canada
Canada, Newfoundland and Labrador
      GSK Clinical Trials Call Center, Bay Roberts,  Newfoundland and Labrador,  A0G 1G0,  Canada
Canada, Ontario
      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
Canada, Prince Edward Island
      GSK Clinical Trials Call Center, Montague,  Prince Edward Island,  C0A 1R0,  Canada
      GSK Clinical Trials Call Center, Charlottetown,  Prince Edward Island,  C1A 5Y9,  Canada
Canada, Quebec
      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
Puerto Rico
      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
      Gildred Colon-Vega, San Juan,  00907,  Puerto Rico

Study chairs or principal investigators

GSK Clinical Trial, MD,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  COR103560
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 25, 2005
ClinicalTrials.gov Identifier:  NCT00123903
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26