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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Microalbuminuria

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

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

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

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.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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.

Eligibility

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.

Locations and Contacts

GSK Investigational Site, Rio Grande 00745, Puerto Rico

GSK Investigational Site, San Juan 00907, Puerto Rico

GSK Investigational Site, Birmingham, Alabama 35205, United States

GSK Investigational Site, Mobile, Alabama 36617, United States

GSK Investigational Site, Calgary, Alberta T2E 7C5, Canada

GSK Investigational Site, Phoenix, Arizona 85023, United States

GSK Investigational Site, New Westminster, British Columbia V3L 3W4, Canada

GSK Investigational Site, Vancouver, British Columbia V7N 4M2, Canada

GSK Investigational Site, Fullerton, California 92835, United States

GSK Investigational Site, Los Angeles, California 90057, United States

GSK Investigational Site, Mission Viejo, California 92691, United States

GSK Investigational Site, Colorado Springs, Colorado 80919, United States

GSK Investigational Site, Hollywood, Florida 33023, United States

GSK Investigational Site, Miami, Florida 33156, United States

GSK Investigational Site, Miami, Florida 33169, United States

GSK Investigational Site, Sarasota, Florida 34239, United States

GSK Investigational Site, Tampa, Florida 33614, United States

GSK Investigational Site, Decatur, Georgia 30035, United States

GSK Investigational Site, Chicago, Illinois 60612, United States

GSK Investigational Site, Chicago, Illinois 60607, United States

GSK Investigational Site, Melrose Park, Illinois 60160, United States

GSK Investigational Site, Avon, Indiana 46123, United States

GSK Investigational Site, Elkhart, Indiana 46515, United States

GSK Investigational Site, Evansville, Indiana 47713, United States

GSK Investigational Site, Evansville, Indiana 47714, United States

GSK Investigational Site, Indianapolis, Indiana 46250, United States

GSK Investigational Site, Lafayette, Louisiana 70503, United States

GSK Investigational Site, Winnipeg, Manitoba R3K 0Y8, Canada

GSK Investigational Site, Winnipeg, Manitoba R3E 3P4, Canada

GSK Investigational Site, Worcester, Massachusetts 01608, United States

GSK Investigational Site, Las Vegas, Nevada 89119, United States

GSK Investigational Site, Voorhees, New Jersey 08043, United States

GSK Investigational Site, Buffalo, New York 14222, United States

GSK Investigational Site, Camillus, New York 13031, United States

GSK Investigational Site, East Syracuse, New York 13057, United States

GSK Investigational Site, Kingston, New York 12401, United States

GSK Investigational Site, Port Chester, New York 10573, United States

GSK Investigational Site, Rochester, New York 14618, United States

GSK Investigational Site, Bay Roberts, Newfoundland and Labrador A0G 1G0, Canada

GSK Investigational Site, Charlotte, North Carolina 28211, United States

GSK Investigational Site, Greensboro, North Carolina 27401, United States

GSK Investigational Site, Raleigh, North Carolina 27609, United States

GSK Investigational Site, Cleveland, Ohio 44130, United States

GSK Investigational Site, Kettering, Ohio 45429, United States

GSK Investigational Site, Brampton, Ontario L6T 3J1, Canada

GSK Investigational Site, Hamilton, Ontario L8L 5G8, Canada

GSK Investigational Site, Kitchener, Ontario N2G 1N9, Canada

GSK Investigational Site, London, Ontario N5W 6A2, Canada

GSK Investigational Site, Stoney Creek, Ontario L8G 2V6, Canada

GSK Investigational Site, Toronto, Ontario M9W 4L6, Canada

GSK Investigational Site, Beaver, Pennsylvania 15009, United States

GSK Investigational Site, Havertown, Pennsylvania 19083, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19152, United States

GSK Investigational Site, Charlottetown, Prince Edward Island C1A 5Y9, Canada

GSK Investigational Site, Montague, Prince Edward Island C0A 1R0, Canada

GSK Investigational Site, Bonaventure, Quebec G0C 1E0, Canada

GSK Investigational Site, Mirabel, Quebec J7J 2K8, Canada

GSK Investigational Site, Montreal, Quebec H2K 4L5, Canada

GSK Investigational Site, Pointe-Claire, Quebec H9R 4S3, Canada

GSK Investigational Site, Saint-Romuald, Quebec G6W 5M6, Canada

GSK Investigational Site, Trois Rivieres, Quebec G8T 7A1, Canada

GSK Investigational Site, Greer, South Carolina 29651, United States

GSK Investigational Site, Johnson City, Tennessee 37604, United States

GSK Investigational Site, Dallas, Texas 75231, United States

GSK Investigational Site, Dallas, Texas 75390-9068, United States

GSK Investigational Site, Fort Worth, Texas 76104, United States

GSK Investigational Site, Galveston, Texas 77555-0188, United States

GSK Investigational Site, Houston, Texas 77030, United States

GSK Investigational Site, Midland, Texas 79705, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

GSK Investigational Site, San Antonio, Texas 78216, United States

GSK Investigational Site, Burke, Virginia 22015, United States

GSK Investigational Site, Springfield, Virginia 22151, United States

GSK Investigational Site, Edmonds, Washington 98026, United States

GSK Investigational Site, Spokane, Washington 99206, United States

GSK Investigational Site, Wenatchee, Washington 98801, United States

Additional Information

Starting date: July 2005
Last updated: October 1, 2010

Page last updated: August 23, 2015

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