Last updated: 11/04/2018 05:58:08
COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria
EudraCT ID
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy
Timeframe: Baseline (Randomization Visit) and Month 6
Secondary outcomes:
Percentage of par who achieved normoalbuminuria at 6 months of maintenance therapy
Timeframe: Month 6
Percentage of par who progressed to macroalbuminuria after 6 months of maintenance therapy
Timeframe: Month 6 to Month 7
Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP)
Timeframe: Baseline (Randomization Visit) and Month 6
Change from Pre-screening visit to month 6 LOCF in urine ACR
Timeframe: Pre-screening Visit and Month 6
Change from Baseline visit to month 6 (LOCF) in lipids including total cholesterol, low density lipid, high density lipid and Triglycerides
Timeframe: Baseline (Randomization visit) and Month 6
Percentage of par with occurrence of new onset diabetes mellitus at month 6 LOCF
Timeframe: Baseline (Randomization visit) and Month 6
Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment
Timeframe: Baseline (Randomization Visit) and Month 6
Changes from baseline in heart rate at month 6 of treatment
Timeframe: Baseline (Randomization visit) and Month 6
Percentage of par who required add-on therapy to reach target blood pressure at any time during the study
Timeframe: Up to 6 months
Number of par with clinical chemistry parameters and hematology parameters of potential clinical concern (PCC) at any time on-treatment
Timeframe: Up to 6 months
Number of par with vital signs of PCC at any time on-treatment
Timeframe: Up to 6 months
Interventions:
Drug: metoprolol xl
Drug: carvedilol MR
Drug: lisinopril
Enrollment:
107
Observational study model:
Not applicable
Primary completion date:
2006-09-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Heart failure, Congestive and Microalbuminuria
Product
carvedilol
Collaborators
Not applicable
Study date(s)
July 2005 to May 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19152
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77024
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
Location
GSK Investigational Site
West Grove, Pennsylvania, United States, 19390
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Evansville, Indiana, United States, 47713
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Miami, Florida, United States, 33156
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46250
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V7N 4M2
Status
Study Complete
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0G 1G0
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
Status
Study Complete
Location
GSK Investigational Site
Oregon City, Oregon, United States, 97045
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Olympia, Washington, United States, 98502
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Sarasota, Florida, United States, 34239
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35213
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46254
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kingston, New York, United States, 12401
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90057
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60607
Status
Study Complete
Location
GSK Investigational Site
San Juan, Puerto Rico, Puerto Rico, 00907
Status
Study Complete
Location
GSK Investigational Site
Inglewood, California, United States, 90301
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fullerton, California, United States, 92835
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Edmonds, Washington, United States, 98026
Status
Study Complete
Location
GSK Investigational Site
Beaumont, Texas, United States, 77701
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Decatur, Georgia, United States, 30035
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75390-9068
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Trois Rivieres, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Ayer, Massachusetts, United States, 01432
Status
Terminated/Withdrawn
Location
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hollywood, Florida, United States, 33023
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14222
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37604
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78216
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Montague, Prince Edward Island, Canada, C0A 1R0
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14618
Status
Study Complete
Location
GSK Investigational Site
Columbus, Ohio, United States, 43210-1296
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28211
Status
Study Complete
Location
GSK Investigational Site
Rio Grande, Puerto Rico, Puerto Rico, 00745
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99208
Status
Study Complete
Location
GSK Investigational Site
Melrose Park, Illinois, United States, 60160
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80919
Status
Study Complete
Location
GSK Investigational Site
Redondo Beach, California, United States, 90277
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Galveston, Texas, United States, 77555-0188
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New Westminster, British Columbia, Canada, V3L 3W4
Status
Study Complete
Location
GSK Investigational Site
Port Chester, New York, United States, 10573
Status
Study Complete
Location
GSK Investigational Site
Saint-Romuald, Québec, Canada, G6W 5M6
Status
Study Complete
Location
GSK Investigational Site
Havertown, Pennsylvania, United States, 19083
Status
Study Complete
Location
GSK Investigational Site
Oakland, California, United States, 94609
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Reading, Pennsylvania, United States, 19601
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85023
Status
Study Complete
Location
GSK Investigational Site
Worcester, Massachusetts, United States, 01608
Status
Study Complete
Location
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99207
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Camillus, New York, United States, 13031
Status
Study Complete
Location
GSK Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 5Y9
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99206
Status
Study Complete
Location
GSK Investigational Site
Elkhart, Indiana, United States, 46515
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Springfield, Virginia, United States, 22151
Status
Study Complete
Location
GSK Investigational Site
East Syracuse, New York, United States, 13057
Status
Study Complete
Location
GSK Investigational Site
Stoney Creek, Ontario, Canada, L8G 2V6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Beaver, Pennsylvania, United States, 15009
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2006-09-05
Actual study completion date
2006-09-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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