Last updated: 11/04/2018 05:58:08

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

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GSK study ID
COR103560
See study documents
Clinicaltrials.gov ID
NCT00123903
See results summary
EudraCT ID
2006-000034-12
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2006-09-05
    Observational study model:
    Not applicable
    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
    Status
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    Location
    GSK Investigational Site
    London, Ontario, Canada, N5W 6A2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19152
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M9W 4L6
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75231
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77024
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47714
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Grove, Pennsylvania, United States, 19390
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47713
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33156
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Burke, Virginia, United States, 22015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46250
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vancouver, British Columbia, Canada, V7N 4M2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bay Roberts, Newfoundland and Labrador, Canada, A0G 1G0
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lafayette, Louisiana, United States, 70503
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oregon City, Oregon, United States, 97045
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Olympia, Washington, United States, 98502
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pointe-Claire, Québec, Canada, H9R 4S3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winnipeg, Manitoba, Canada, R3K 0Y8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sarasota, Florida, United States, 34239
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greensboro, North Carolina, United States, 27401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35213
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46254
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Kingston, New York, United States, 12401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kettering, Ohio, United States, 45429
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bonaventure, Québec, Canada, G0C 1E0
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90057
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60607
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brampton, Ontario, Canada, L6T 3T1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Juan, Puerto Rico, Puerto Rico, 00907
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Inglewood, California, United States, 90301
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33169
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fullerton, California, United States, 92835
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orangeburg, South Carolina, United States, 29118
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Edmonds, Washington, United States, 98026
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Beaumont, Texas, United States, 77701
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Decatur, Georgia, United States, 30035
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75390-9068
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60612
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kitchener, Ontario, Canada, N2G 1N9
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Trois Rivieres, Québec, Canada, G8T 7A1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ayer, Massachusetts, United States, 01432
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    East Providence, Rhode Island, United States, 02914
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hollywood, Florida, United States, 33023
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wenatchee, Washington, United States, 98801
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Buffalo, New York, United States, 14222
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27609
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Johnson City, Tennessee, United States, 37604
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78216
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76104
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33614
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Avon, Indiana, United States, 46123
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Montague, Prince Edward Island, Canada, C0A 1R0
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rochester, New York, United States, 14618
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43210-1296
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mission Viejo, California, United States, 92691
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mirabel, Québec, Canada, J7J 2K8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28211
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rio Grande, Puerto Rico, Puerto Rico, 00745
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Melrose Park, Illinois, United States, 60160
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Colorado Springs, Colorado, United States, 80919
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Redondo Beach, California, United States, 90277
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Galveston, Texas, United States, 77555-0188
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Montreal, Québec, Canada, H2K 4L5
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73112
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    New Westminster, British Columbia, Canada, V3L 3W4
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Port Chester, New York, United States, 10573
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hamilton, Ontario, Canada, L8L 5G8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Saint-Romuald, Québec, Canada, G6W 5M6
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Havertown, Pennsylvania, United States, 19083
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oakland, California, United States, 94609
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pembroke Pines, Florida, United States, 33024
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Reading, Pennsylvania, United States, 19601
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Calgary, Alberta, Canada, T2E 7C5
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85023
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winnipeg, Manitoba, Canada, R3E 3P4
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Worcester, Massachusetts, United States, 01608
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Voorhees, New Jersey, United States, 08043
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99207
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Greer, South Carolina, United States, 29651
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Camillus, New York, United States, 13031
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mobile, Alabama, United States, 36617
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlottetown, Prince Edward Island, Canada, C1A 5Y9
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99206
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Elkhart, Indiana, United States, 46515
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Midland, Texas, United States, 79705
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89119
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Springfield, Virginia, United States, 22151
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44130
    Status
    Study Complete
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    Location
    GSK Investigational Site
    East Syracuse, New York, United States, 13057
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Stoney Creek, Ontario, Canada, L8G 2V6
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Beaver, Pennsylvania, United States, 15009
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    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.

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