Clincosm LogoSign in Get a demo

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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00273052
Collaborator
(none)
514
Enrollment
120
Locations
2
Arms
23.7
Duration (Months)
4.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Carvedilol Phosphate modified release formulation
  • Drug: metoprolol succinate
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
514 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Jan 5, 2006
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 28, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Carvedilol Phosphate modified release formulation

Drug: Carvedilol Phosphate modified release formulation
Active Comparator: metoprolol succinate

Drug: metoprolol succinate
Other Names:
  • Carvedilol Phosphate modified release formulation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6 [Baseline and Month 6]

      Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.

    2. Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6 [Baseline and Month 6]

      Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.

    Secondary Outcome Measures

    1. Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6 [Baseline and Month 6]

      Blood draw for hs-CRP. Change = Month 6 value minus Baseline value.

    2. Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6 [Baseline and Month 6]

      Blood draw for LpPLA2 activity. Change = Month 6 value minus Baseline value.

    3. Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6 [Baseline and Month 6]

      Manual physical examination (cuff blood pressure). Change = Month 6 value minus Baseline value.

    4. Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6 [Baseline and Month 6]

      Manual physical examination. Change = Month 6 value minus Baseline value. (BPM=beats per minute)

    5. Change From Baseline in Weight by Treatment Group at Maintenance Month [Baseline and Month 6]

      Manual physical examination. Change = Month 6 value minus Baseline value.

    6. Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 [Baseline and Month 6]

      Blood draw for lipid levels. Full beta Quant test performed with HDL subclasses and IDL. IDL=Intermediate density lipoproteins, LDL=Low-density lipoprotein, VLDL=Very Low density lipoprotein, HDL=High-density lipoprotein. Change = Month 6 value minus Baseline value.

    7. Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6 [Baseline and Month 6]

      Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value.

    8. Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6 [Baseline and Month 6]

      Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.

    9. Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 [Baseline and Month 6]

      Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.

    10. Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6 [Baseline and Month 6]

      Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.

    11. Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6 [Baseline and Month 6]

      Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.

    12. Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 [Baseline and Month 6]

      Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Birmingham Alabama United States 35205
    2 GSK Investigational Site Birmingham Alabama United States 35209
    3 GSK Investigational Site Birmingham Alabama United States 35211
    4 GSK Investigational Site Birmingham Alabama United States 35242
    5 GSK Investigational Site Montgomery Alabama United States 36106
    6 GSK Investigational Site Chandler Arizona United States 85224
    7 GSK Investigational Site Mesa Arizona United States 85201
    8 GSK Investigational Site Phoenix Arizona United States 85014
    9 GSK Investigational Site Phoenix Arizona United States 85029
    10 GSK Investigational Site Tucson Arizona United States 85723
    11 GSK Investigational Site Tucson Arizona United States 85741
    12 GSK Investigational Site Fayetteville Arkansas United States 72701
    13 GSK Investigational Site Little Rock Arkansas United States 72205
    14 GSK Investigational Site Carmichael California United States 95608
    15 GSK Investigational Site Healdsburg California United States 95448
    16 GSK Investigational Site Irvine California United States 92618
    17 GSK Investigational Site La Jolla California United States 92037
    18 GSK Investigational Site Los Angeles California United States 90057
    19 GSK Investigational Site Los Angeles California United States 90502
    20 GSK Investigational Site Mission Viejo California United States 92691
    21 GSK Investigational Site Poway California United States 92064
    22 GSK Investigational Site Sacramento California United States 95816
    23 GSK Investigational Site San Diego California United States 92177
    24 GSK Investigational Site Spring Valley California United States 91978
    25 GSK Investigational Site Stockton California United States 95204
    26 GSK Investigational Site Torrance California United States 90503
    27 GSK Investigational Site Vista California United States 92084
    28 GSK Investigational Site Avon Connecticut United States 06001
    29 GSK Investigational Site Altamonte Springs Florida United States 32714
    30 GSK Investigational Site Clearwater Florida United States 33755
    31 GSK Investigational Site Fort Lauderdale Florida United States 33308
    32 GSK Investigational Site Jacksonville Florida United States 32205
    33 GSK Investigational Site Jacksonville Florida United States 32216
    34 GSK Investigational Site Jacksonville Florida United States 32259
    35 GSK Investigational Site Pembroke Pines Florida United States 33024
    36 GSK Investigational Site Atlanta Georgia United States 30308
    37 GSK Investigational Site Marietta Georgia United States 30067
    38 GSK Investigational Site Roswell Georgia United States 30076
    39 GSK Investigational Site Aurora Illinois United States 60504
    40 GSK Investigational Site Chicago Illinois United States 60611
    41 GSK Investigational Site Gillespie Illinois United States 62033
    42 GSK Investigational Site Vernon Hills Illinois United States 60061
    43 GSK Investigational Site Evansville Indiana United States 47714
    44 GSK Investigational Site Indianapolis Indiana United States 46260
    45 GSK Investigational Site Wichita Kansas United States 67205
    46 GSK Investigational Site Wichita Kansas United States 67214
    47 GSK Investigational Site Bossier City Louisiana United States 71111
    48 GSK Investigational Site Auburn Maine United States 04210
    49 GSK Investigational Site Natick Massachusetts United States 01760
    50 GSK Investigational Site Taunton Massachusetts United States 02780.
    51 GSK Investigational Site West Yarmouth Massachusetts United States 02673
    52 GSK Investigational Site Detroit Michigan United States 48235
    53 GSK Investigational Site Brooklyn Center Minnesota United States 55430
    54 GSK Investigational Site Olive Branch Mississippi United States 38654
    55 GSK Investigational Site Saint Louis Missouri United States 63141
    56 GSK Investigational Site Springfield Missouri United States 65807
    57 GSK Investigational Site Omaha Nebraska United States 68134
    58 GSK Investigational Site Omaha Nebraska United States 68144
    59 GSK Investigational Site Henderson Nevada United States 89014
    60 GSK Investigational Site Las Vegas Nevada United States 89119
    61 GSK Investigational Site Las Vegas Nevada United States 89128
    62 GSK Investigational Site Brick New Jersey United States 08724
    63 GSK Investigational Site Elizabeth New Jersey United States 07202
    64 GSK Investigational Site Albuquerque New Mexico United States 87102
    65 GSK Investigational Site Albuquerque New Mexico United States 87108
    66 GSK Investigational Site East Syracuse New York United States 13057
    67 GSK Investigational Site Endwell New York United States 13760
    68 GSK Investigational Site Fishkill New York United States 12524
    69 GSK Investigational Site New York New York United States 10016
    70 GSK Investigational Site New York New York United States 10021
    71 GSK Investigational Site Charlotte North Carolina United States 28207
    72 GSK Investigational Site Raleigh North Carolina United States 27612
    73 GSK Investigational Site Statesville North Carolina United States 28625
    74 GSK Investigational Site Wilmington North Carolina United States 28401
    75 GSK Investigational Site Winston-Salem North Carolina United States 27103
    76 GSK Investigational Site Cincinnati Ohio United States 45245
    77 GSK Investigational Site Cincinnati Ohio United States 45246
    78 GSK Investigational Site Cleveland Ohio United States 44195
    79 GSK Investigational Site Kettering Ohio United States 45429
    80 GSK Investigational Site Oklahoma City Oklahoma United States 73112
    81 GSK Investigational Site Erie Pennsylvania United States 16508
    82 GSK Investigational Site Warminster Pennsylvania United States 18974
    83 GSK Investigational Site West Chester Pennsylvania United States 19380
    84 GSK Investigational Site Columbia South Carolina United States 29201
    85 GSK Investigational Site Greer South Carolina United States 29651
    86 GSK Investigational Site Hartsville South Carolina United States 29550
    87 GSK Investigational Site Simpsonville South Carolina United States 29681
    88 GSK Investigational Site Bristol Tennessee United States 37620
    89 GSK Investigational Site Kingsport Tennessee United States 37660
    90 GSK Investigational Site Corpus Christi Texas United States 78404
    91 GSK Investigational Site San Antonio Texas United States 78237
    92 GSK Investigational Site San Antonio Texas United States 78258
    93 GSK Investigational Site Salt Lake City Utah United States 84109
    94 GSK Investigational Site Burke Virginia United States 22015
    95 GSK Investigational Site Galax Virginia United States 24333
    96 GSK Investigational Site Manassas Virginia United States 22015
    97 GSK Investigational Site Newport News Virginia United States 23606
    98 GSK Investigational Site Richmond Virginia United States 23294
    99 GSK Investigational Site Springfield Virginia United States 22151
    100 GSK Investigational Site Virginia Beach Virginia United States 23451
    101 GSK Investigational Site Walla Walla Washington United States 99362
    102 GSK Investigational Site Lewisburg West Virginia United States 24901
    103 GSK Investigational Site Calgary Alberta Canada T2E 7C5
    104 GSK Investigational Site Calgary Alberta Canada T3C 3P1
    105 GSK Investigational Site Edmonton Alberta Canada T5A 4L8
    106 GSK Investigational Site St. John's Newfoundland and Labrador Canada A1E 2E2
    107 GSK Investigational Site Truro Nova Scotia Canada B2N 1L2
    108 GSK Investigational Site Brampton Ontario Canada L6T 3T1
    109 GSK Investigational Site London Ontario Canada N5W 6A2
    110 GSK Investigational Site Newmarket Ontario Canada L3Y 5G8
    111 GSK Investigational Site Peterborough Ontario Canada K9J 7B3
    112 GSK Investigational Site Sarnia Ontario Canada N7T 4X3
    113 GSK Investigational Site Sudbury Ontario Canada P3C 5K7
    114 GSK Investigational Site Sudbury Ontario Canada P3E 1H5
    115 GSK Investigational Site Gatineau Quebec Canada J8Y 6S8
    116 GSK Investigational Site Mirabel Quebec Canada J7J 2K8
    117 GSK Investigational Site Trois Rivieres Quebec Canada G8T 7A1
    118 GSK Investigational Site Ponce Puerto Rico 731
    119 GSK Investigational Site Rio Grande Puerto Rico 00745
    120 GSK Investigational Site Rio Piedras Puerto Rico 00935

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00273052
    Other Study ID Numbers:
    • COR103561
    First Posted:
    Jan 9, 2006
    Last Update Posted:
    Jun 25, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by GlaxoSmithKline
    hypertension
    Additional relevant MeSH terms:
    Hypertension
    Metoprolol
    Carvedilol

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Period Title: Overall Study
    STARTED 290 278
    COMPLETED 221 190
    NOT COMPLETED 69 88

    Baseline Characteristics

    Arm/Group Title Coreg CR Toprol XL Total
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily) Total of all reporting groups
    Overall Participants 290 278 568
    Age, Customized (participants) [Number]
    < 65 years
    260
    89.7%
    244
    87.8%
    504
    88.7%
    >=65 years
    30
    10.3%
    34
    12.2%
    64
    11.3%
    Sex: Female, Male (Count of Participants)
    Female
    137
    47.2%
    133
    47.8%
    270
    47.5%
    Male
    153
    52.8%
    145
    52.2%
    298
    52.5%
    Race/Ethnicity, Customized (participants) [Number]
    Black
    24
    8.3%
    28
    10.1%
    52
    9.2%
    White/Caucasian
    239
    82.4%
    226
    81.3%
    465
    81.9%
    Other
    27
    9.3%
    24
    8.6%
    51
    9%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6
    Description Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 235 206
    Number [mg/dL]
    2.65
    10.39
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Coreg CR, Toprol XL
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0141
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Median Difference (Net)
    Estimated Value -8.026
    Confidence Interval () 95%
    -15.35 to -0.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments Median difference = Coreg CR - Toprol XL
    2. Primary Outcome
    Title Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6
    Description Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 235 206
    Number [mg/dL]
    -4.4
    -5.1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Coreg CR, Toprol XL
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6068
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.7
    Confidence Interval () 95%
    -2.4 to 3.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Mean difference = Coreg CR - Toprol XL
    3. Secondary Outcome
    Title Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6
    Description Blood draw for hs-CRP. Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 231 203
    Number [mg/dL]
    -1.76
    0.49
    4. Secondary Outcome
    Title Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6
    Description Blood draw for LpPLA2 activity. Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 222 189
    Number [mcmol/min/L]
    -2.38
    -2.23
    5. Secondary Outcome
    Title Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6
    Description Manual physical examination (cuff blood pressure). Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 280 269
    Systolic Blood Pressure
    -15.90
    -16.23
    Diastolic Blood Pressure
    -10.89
    -11.06
    6. Secondary Outcome
    Title Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6
    Description Manual physical examination. Change = Month 6 value minus Baseline value. (BPM=beats per minute)
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 280 269
    Number [bpm]
    -5.98
    -6.07
    7. Secondary Outcome
    Title Change From Baseline in Weight by Treatment Group at Maintenance Month
    Description Manual physical examination. Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 280 269
    Number [kg]
    1.01
    0.73
    8. Secondary Outcome
    Title Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6
    Description Blood draw for lipid levels. Full beta Quant test performed with HDL subclasses and IDL. IDL=Intermediate density lipoproteins, LDL=Low-density lipoprotein, VLDL=Very Low density lipoprotein, HDL=High-density lipoprotein. Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 280 269
    Total Serum Cholesterol
    0.1
    -0.7
    Low-Density Lipoprotein (LDL)
    -1.1
    -1.7
    Low+Very Low Density Lipoprotein
    0.9
    0.4
    High-Density Lipoprotein 2 (HDL2)
    -1.45
    -6.5
    High-Density Lipoprotein 3 (HDL3)
    -4.0
    -3.5
    Low-Density Lipoprotein-Relative Flotation
    0.166
    -1.360
    Intermediate Density Lipoproteins+VLDL
    2.0
    5.6
    9. Secondary Outcome
    Title Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6
    Description Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 280 269
    Apolipoprotein A-1 (Apo-A1)
    -1.82
    -3.45
    Apolipoprotein B (Apo-B)
    -1.16
    0.81
    10. Secondary Outcome
    Title Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6
    Description Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 280 269
    Number [uIU/mL]
    -1.21
    1.35
    11. Secondary Outcome
    Title Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6
    Description Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 280 269
    Number [Percent Change]
    0.01
    0.04
    12. Secondary Outcome
    Title Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6
    Description Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 280 269
    Number [ng/mL]
    -0.23
    0.20
    13. Secondary Outcome
    Title Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6
    Description Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 280 269
    Number [Percent Change]
    2.05
    -4.14
    14. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6
    Description Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.
    Time Frame Baseline and Month 6

    Outcome Measure Data

    Analysis Population Description
    The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
    Measure Participants 280 269
    Number [mg/dL]
    0.94
    1.20

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Coreg CR Toprol XL
    Arm/Group Description Results include only treatment emergent events. Results include only treatment emergent events.
    All Cause Mortality
    Coreg CR Toprol XL
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Coreg CR Toprol XL
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/ (NaN) 5/ (NaN)
    Cardiac disorders
    Myocardial Infarction 1/290 (0.3%) 0/278 (0%)
    Palpitations 1/290 (0.3%) 0/278 (0%)
    Gastrointestinal disorders
    Colitis ischaemic 1/290 (0.3%) 0/278 (0%)
    Gastroesophagael reflux disease 1/290 (0.3%) 0/278 (0%)
    Umbilical hernia 1/290 (0.3%) 0/278 (0%)
    General disorders
    Chest discomfort 1/290 (0.3%) 0/278 (0%)
    Infections and infestations
    Peridiverticular abscess 0/290 (0%) 1/278 (0.4%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer 0/290 (0%) 1/278 (0.4%)
    Nervous system disorders
    Orthostatic hypotension 0/290 (0%) 1/278 (0.4%)
    Presyncope 0/290 (0%) 1/278 (0.4%)
    Psychiatric disorders
    Depression suicidal 1/290 (0.3%) 0/278 (0%)
    Renal and urinary disorders
    Hydronephrosis 0/290 (0%) 1/278 (0.4%)
    Vascular disorders
    Hypertension 1/290 (0.3%) 0/278 (0%)
    Other (Not Including Serious) Adverse Events
    Coreg CR Toprol XL
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 186/ (NaN) 160/ (NaN)
    Gastrointestinal disorders
    Nausea 18/290 (6.2%) 11/278 (4%)
    Diarrhea 12/290 (4.1%) 15/278 (5.4%)
    General disorders
    Edema Peripheral 29/290 (10%) 25/278 (9%)
    Fatigue 22/290 (7.6%) 29/278 (10.4%)
    Infections and infestations
    Nasopharyngitis 16/290 (5.5%) 17/278 (6.1%)
    Upper Respiratory Tract Infection 19/290 (6.6%) 12/278 (4.3%)
    Nervous system disorders
    Headache 42/290 (14.5%) 33/278 (11.9%)
    Dizziness 28/290 (9.7%) 18/278 (6.5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

    Results Point of Contact

    Name/Title GSK Response Center
    Organization GlaxoSmithKline
    Phone 866-435-7343
    Email
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00273052
    Other Study ID Numbers:
    • COR103561
    First Posted:
    Jan 9, 2006
    Last Update Posted:
    Jun 25, 2018
    Last Verified:
    Mar 1, 2018