COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria
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
1 other identifier
interventional
1,220
3 countries
94
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2005
Shorter than P25 for phase_3
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 22, 2005
CompletedFirst Posted
Study publicly available on registry
July 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedJanuary 18, 2017
January 1, 2017
10 months
July 22, 2005
January 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy.
Baseline (Randomization Visit) and Month 6
Secondary Outcomes (10)
Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy.
Month 6
Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy.
Month 6
Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP)
Baseline (Randomization Visit) and Month 6
Change from Pre-screening visit to month 6 LOCF in urine ACR.
Pre-screening Visit and Month 6
Change from baseline to visit to month 6 LOCF in lipids including total cholesterol, low density lipid (LDL), high density lipid (HDL) and Triglycerides (TG)
Baseline (Randomization visit) and Month 6
- +5 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (94)
GSK Investigational Site
Birmingham, Alabama, 35213, United States
GSK Investigational Site
Mobile, Alabama, 36617, United States
GSK Investigational Site
Phoenix, Arizona, 85023, United States
GSK Investigational Site
Fullerton, California, 92835, United States
GSK Investigational Site
Inglewood, California, 90301, United States
GSK Investigational Site
Los Angeles, California, 90057, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Oakland, California, 94609, United States
GSK Investigational Site
Redondo Beach, California, 90277, 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
Pembroke Pines, Florida, 33024, 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, 60607, United States
GSK Investigational Site
Chicago, Illinois, 60612, 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
Indianapolis, Indiana, 46254, United States
GSK Investigational Site
Lafayette, Louisiana, 70503, United States
GSK Investigational Site
Ayer, Massachusetts, 01432, United States
GSK Investigational Site
Worcester, Massachusetts, 01608, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Voorhees Township, 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
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
Columbus, Ohio, 43210-1296, United States
GSK Investigational Site
Kettering, Ohio, 45429, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Oregon City, Oregon, 97045, United States
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
Reading, Pennsylvania, 19601, United States
GSK Investigational Site
West Grove, Pennsylvania, 19390, United States
GSK Investigational Site
East Providence, Rhode Island, 02914, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Johnson City, Tennessee, 37604, United States
GSK Investigational Site
Beaumont, Texas, 77701, 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, 77024, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Midland, Texas, 79705, United States
GSK Investigational Site
San Antonio, Texas, 78216, United States
GSK Investigational Site
San Antonio, Texas, 78229, 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
Olympia, Washington, 98502, United States
GSK Investigational Site
Spokane, Washington, 99206, United States
GSK Investigational Site
Spokane, Washington, 99207, United States
GSK Investigational Site
Spokane, Washington, 99208, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Calgary, Alberta, T2E 7C5, Canada
GSK Investigational Site
New Westminster, British Columbia, V3L 3W4, Canada
GSK Investigational Site
Vancouver, British Columbia, V7N 4M2, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3E 3P4, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3K 0Y8, Canada
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0G 1G0, Canada
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
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-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Río Grande, Puerto Rico, 00745, Puerto Rico
GSK Investigational Site
San Juan, Puerto Rico, 00907, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2005
First Posted
July 26, 2005
Study Start
July 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
January 18, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.