Last updated: 11/04/2018 05:58:36

COREG MR Versus TOPROL-XL On The Lipid Profile Of Normolipidemic Or Mildly Dyslipidemic Patients With Hypertension

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GSK study ID
COR103561
See study documents
Clinicaltrials.gov ID
NCT00273052
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Phosphate Modified Release Formulation (COREG- MR) with Metoprolol Succinate (TOPROL XL) on the Lipid Profile in Normolipidemic, or Mildly Dyslipidemic Hypertensive Patients
Trial description: This study was designed to determine whether treatment with COREG MR is more effective at maintaining a better lipid profile than treatment with TOPROL-XL for hypertension.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in Triglycerides levels by Treatment Group at Maintenance Month 6

Timeframe: Baseline and Month 6

Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C) levels by Treatment Group at Maintenance Month 6

Timeframe: Baseline and Month 6

Secondary outcomes:

Change from Baseline in Log Transformed High Sensitivity C-reactive protein (hs-CRP) by Treatment Group at Maintenance Month 6

Timeframe: Baseline and Month 6

Change from Baseline in Log Transformed Lipoprotein-associated phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6

Timeframe: Baseline and Month 6

Change from Baseline in Blood Pressure by Treatment Group at Maintenance Month 6

Timeframe: Baseline and Month 6

Change from Baseline in Heart Rate by Treatment Group at Maintenance Month 6

Timeframe: Baseline and Month 6

Change From Baseline in Weight by Treatment Group at Maintenance Month

Timeframe: Baseline and Month 6

Change from Baseline in Additional Lipid Parameters by Treatment Group with Unit of Measures of mg/dL at Maintenance Month 6

Timeframe: Baseline and Month 6

Change from Baseline in Additional Lipid Parameters by Treatment Group with Unit of Measures of g/L at Maintenance Month 6

Timeframe: Baseline and Month 6

Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Timeframe: Baseline and Month 6

Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Timeframe: Baseline and Month 6

Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Timeframe: Baseline and Month 6

Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Timeframe: Baseline and Month 6

Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6

Timeframe: Baseline and Month 6

Interventions:
  • Drug: Carvedilol Phosphate modified release formulation
  • Drug: metoprolol succinate
    • Enrollment:
    514
    Primary completion date:
    2007-28-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Hypertension
    Product
    carvedilol
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to December 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 80 years
    Accepts healthy volunteers
    No
    • Documented history of hypertension
    • Triglycerides of 120-400 mg/mL
    • Has known contraindication to alpha- or beta-blocker therapy.
    • Has taken any non-ocular beta-blockers within three months before screening.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Documented history of hypertension
    • Triglycerides of 120-400 mg/mL
    • LDLc levels not requiring lipid lowering medication.
    Exclusion criteria:
    • Has known contraindication to alpha- or beta-blocker therapy.
    • Has taken any non-ocular beta-blockers within three months before screening.
    • Has Type I or II diabetes.
    • Taking lipid lowering medications.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Poway, California, United States, 92064
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Elizabeth, New Jersey, United States, 07202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27612
    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
    Ponce, Puerto Rico, Puerto Rico, 731
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vernon Hills, Illinois, United States, 60061
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Endwell, New York, United States, 13760
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newmarket, Ontario, Canada, L3Y 5G8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Manassas, Virginia, United States, 22015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92177
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35209
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chandler, Arizona, United States, 85224
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85014
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32216
    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
    Corpus Christi, Texas, United States, 78404
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23294
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Truro, Nova Scotia, Canada, B2N 1L2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbia, South Carolina, United States, 29201
    Status
    Study Complete
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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
    Galax, Virginia, United States, 24333
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Edmonton, Alberta, Canada, T5A 4L8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44195
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60611
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35242
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sudbury, Ontario, Canada, P3E 1H5
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90502
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Yarmouth, Massachusetts, United States, 02673
    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
    Sudbury, Ontario, Canada, P3C 5K7
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Stockton, California, United States, 95204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sacramento, California, United States, 95816
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Statesville, North Carolina, United States, 28625
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Henderson, Nevada, United States, 89014
    Status
    Study Complete
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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
    Natick, Massachusetts, United States, 01760
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84109
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Burke, Virginia, United States, 22015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Torrance, California, United States, 90503
    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
    Wichita, Kansas, United States, 67205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Taunton, Massachusetts, United States, 02780.
    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
    Peterborough, Ontario, Canada, K9J 7B3
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Auburn, Maine, United States, 04210
    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
    Roswell, Georgia, United States, 30076
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30308
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kingsport, Tennessee, United States, 37660
    Status
    Study Complete
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    Location
    GSK Investigational Site
    London, Ontario, Canada, N5W 6A2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sarnia, Ontario, Canada, N7T 4X3
    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
    Aurora, Illinois, United States, 60504
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45245
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spring Valley, California, United States, 91978
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brick, New Jersey, United States, 08724
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pembroke Pines, Florida, United States, 33024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68144
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89128
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85029
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wilmington, North Carolina, United States, 28401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bossier City, Louisiana, United States, 71111
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Warminster, Pennsylvania, United States, 18974
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32259
    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
    Tucson, Arizona, United States, 85723
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    West Chester, Pennsylvania, United States, 19380
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73112
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63141
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Simpsonville, South Carolina, United States, 29681
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45246
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78258
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fishkill, New York, United States, 12524
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    New York, New York, United States, 10016
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Altamonte Springs, Florida, United States, 32714
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Calgary, Alberta, Canada, T3C 3P1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Virginia Beach, Virginia, United States, 23451
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16508
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Irvine, California, United States, 92618
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Clearwater, Florida, United States, 33755
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vista, California, United States, 92084
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rio Piedras, Puerto Rico, Puerto Rico, 00935
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Detroit, Michigan, United States, 48235
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Walla Walla, Washington, United States, 99362
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35211
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Healdsburg, California, United States, 95448
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newport News, Virginia, United States, 23606
    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
    Hartsville, South Carolina, United States, 29550
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marietta, Georgia, United States, 30067
    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
    Carmichael, California, United States, 95608
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78237
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gatineau, Québec, Canada, J8Y 6S8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85741
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47714
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Springfield, Missouri, United States, 65807
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brooklyn Center, Minnesota, United States, 55430
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Lauderdale, Florida, United States, 33308
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. John's, Newfoundland and Labrador, Canada, A1E 2E2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68134
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Avon, Connecticut, United States, 06001
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    New York, New York, United States, 10021
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bristol, Tennessee, United States, 37620
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fayetteville, Arkansas, United States, 72701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gillespie, Illinois, United States, 62033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Montgomery, Alabama, United States, 36106
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lewisburg, West Virginia, United States, 24901
    Status
    Study Complete
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    Location
    GSK Investigational Site
    La Jolla, California, United States, 92037
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mesa, Arizona, United States, 85201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46260
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Olive Branch, Mississippi, United States, 38654
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87102
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67214
    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
    Study complete
    Actual primary completion date
    2007-28-12
    Actual study completion date
    2007-28-12

    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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