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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2007-28-12
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
GSK Investigational Site
Poway, California, United States, 92064
Status
Study Complete
Location
GSK Investigational Site
Elizabeth, New Jersey, United States, 07202
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Study Complete
Location
GSK Investigational Site
Trois Rivieres, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Vernon Hills, Illinois, United States, 60061
Status
Study Complete
Location
GSK Investigational Site
Endwell, New York, United States, 13760
Status
Study Complete
Location
GSK Investigational Site
Manassas, Virginia, United States, 22015
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92177
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85014
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78404
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Location
GSK Investigational Site
Galax, Virginia, United States, 24333
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35242
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90502
Status
Study Complete
Location
GSK Investigational Site
West Yarmouth, Massachusetts, United States, 02673
Status
Study Complete
Location
GSK Investigational Site
Rio Grande, Puerto Rico, Puerto Rico, 00745
Status
Study Complete
Location
GSK Investigational Site
Stockton, California, United States, 95204
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95816
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Statesville, North Carolina, United States, 28625
Status
Study Complete
Location
GSK Investigational Site
Henderson, Nevada, United States, 89014
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Natick, Massachusetts, United States, 01760
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90503
Status
Study Complete
Location
GSK Investigational Site
East Syracuse, New York, United States, 13057
Status
Study Complete
Location
GSK Investigational Site
Taunton, Massachusetts, United States, 02780.
Status
Study Complete
Location
GSK Investigational Site
Springfield, Virginia, United States, 22151
Status
Study Complete
Location
GSK Investigational Site
Peterborough, Ontario, Canada, K9J 7B3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Roswell, Georgia, United States, 30076
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Aurora, Illinois, United States, 60504
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45245
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
Location
GSK Investigational Site
Brick, New Jersey, United States, 08724
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89128
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85029
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Location
GSK Investigational Site
Bossier City, Louisiana, United States, 71111
Status
Study Complete
Location
GSK Investigational Site
Warminster, Pennsylvania, United States, 18974
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32259
Status
Study Complete
Location
GSK Investigational Site
Tucson, Arizona, United States, 85723
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Chester, Pennsylvania, United States, 19380
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45246
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78258
Status
Study Complete
Location
GSK Investigational Site
Fishkill, New York, United States, 12524
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Altamonte Springs, Florida, United States, 32714
Status
Study Complete
Location
GSK Investigational Site
Virginia Beach, Virginia, United States, 23451
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
Status
Study Complete
Location
GSK Investigational Site
Irvine, California, United States, 92618
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33755
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92084
Status
Study Complete
Location
GSK Investigational Site
Rio Piedras, Puerto Rico, Puerto Rico, 00935
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Detroit, Michigan, United States, 48235
Status
Study Complete
Location
GSK Investigational Site
Walla Walla, Washington, United States, 99362
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35211
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
Healdsburg, California, United States, 95448
Status
Study Complete
Location
GSK Investigational Site
Newport News, Virginia, United States, 23606
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90057
Status
Study Complete
Location
GSK Investigational Site
Hartsville, South Carolina, United States, 29550
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30067
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Carmichael, California, United States, 95608
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35205
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78237
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
Location
GSK Investigational Site
Springfield, Missouri, United States, 65807
Status
Study Complete
Location
GSK Investigational Site
Brooklyn Center, Minnesota, United States, 55430
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
Status
Study Complete
Location
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1E 2E2
Status
Study Complete
Location
GSK Investigational Site
Avon, Connecticut, United States, 06001
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, Arkansas, United States, 72701
Status
Study Complete
Location
GSK Investigational Site
Gillespie, Illinois, United States, 62033
Status
Study Complete
Location
GSK Investigational Site
Montgomery, Alabama, United States, 36106
Status
Study Complete
Location
GSK Investigational Site
Lewisburg, West Virginia, United States, 24901
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92037
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
Status
Study Complete
Location
GSK Investigational Site
Olive Branch, Mississippi, United States, 38654
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87102
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
Completed
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.
Additional information about the trial
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