Hypertension
Conditions
Keywords
hypertension
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.
Interventions
DRUGCarvedilol Phosphate modified release formulation
DRUGmetoprolol succinate
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Canada, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Coreg CR Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily) | 290 |
| Toprol XL Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily) | 278 |
| Total | 568 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 21 | 19 |
| Overall Study | Lack of Efficacy | 6 | 4 |
| Overall Study | Lost to Follow-up | 7 | 25 |
| Overall Study | Non-Compliance | 3 | 1 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Protocol Violation | 14 | 18 |
| Overall Study | Withdrawal by Subject | 16 | 19 |
| Overall Study | Worsening serum lipid levels | 0 | 2 |
Baseline characteristics
| Characteristic | Coreg CR | Toprol XL | Total |
|---|---|---|---|
| Age, Customized < 65 years | 260 participants | 244 participants | 504 participants |
| Age, Customized >=65 years | 30 participants | 34 participants | 64 participants |
| Race/Ethnicity, Customized Black | 24 participants | 28 participants | 52 participants |
| Race/Ethnicity, Customized Other | 27 participants | 24 participants | 51 participants |
| Race/Ethnicity, Customized White/Caucasian | 239 participants | 226 participants | 465 participants |
| Sex: Female, Male Female | 137 Participants | 133 Participants | 270 Participants |
| Sex: Female, Male Male | 153 Participants | 145 Participants | 298 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 186 / — | 160 / — |
| serious Total, serious adverse events | 8 / — | 5 / — |
Outcome results
Primary
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Coreg CR | Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6 | -4.4 mg/dL |
| Toprol XL | Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6 | -5.1 mg/dL |
p-value: 0.606895% CI: [-2.4, 3.9]ANCOVA
Primary
Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance 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.
Time frame: Baseline and Month 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Coreg CR | Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6 | 2.65 mg/dL |
| Toprol XL | Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6 | 10.39 mg/dL |
p-value: 0.014195% CI: [-15.35, -0.67]ANCOVA
Secondary
Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6
Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value.
Time frame: Baseline and Month 6
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coreg CR | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6 | Apolipoprotein A-1 (Apo-A1) | -1.82 g/L |
| Coreg CR | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6 | Apolipoprotein B (Apo-B) | -1.16 g/L |
| Toprol XL | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6 | Apolipoprotein A-1 (Apo-A1) | -3.45 g/L |
| Toprol XL | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6 | Apolipoprotein B (Apo-B) | 0.81 g/L |
Secondary
Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance 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.
Time frame: Baseline and Month 6
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coreg CR | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | Low+Very Low Density Lipoprotein | 0.9 mg/dL |
| Coreg CR | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | High-Density Lipoprotein 3 (HDL3) | -4.0 mg/dL |
| Coreg CR | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | Low-Density Lipoprotein (LDL) | -1.1 mg/dL |
| Coreg CR | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | Low-Density Lipoprotein-Relative Flotation | 0.166 mg/dL |
| Coreg CR | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | High-Density Lipoprotein 2 (HDL2) | -1.45 mg/dL |
| Coreg CR | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | Intermediate Density Lipoproteins+VLDL | 2.0 mg/dL |
| Coreg CR | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | Total Serum Cholesterol | 0.1 mg/dL |
| Toprol XL | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | Intermediate Density Lipoproteins+VLDL | 5.6 mg/dL |
| Toprol XL | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | Total Serum Cholesterol | -0.7 mg/dL |
| Toprol XL | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | Low-Density Lipoprotein (LDL) | -1.7 mg/dL |
| Toprol XL | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | Low+Very Low Density Lipoprotein | 0.4 mg/dL |
| Toprol XL | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | High-Density Lipoprotein 2 (HDL2) | -6.5 mg/dL |
| Toprol XL | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | High-Density Lipoprotein 3 (HDL3) | -3.5 mg/dL |
| Toprol XL | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | Low-Density Lipoprotein-Relative Flotation | -1.360 mg/dL |
Secondary
Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6
Manual physical examination (cuff blood pressure). Change = Month 6 value minus Baseline value.
Time frame: Baseline and Month 6
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coreg CR | Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6 | Systolic Blood Pressure | -15.90 mm Hg |
| Coreg CR | Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6 | Diastolic Blood Pressure | -10.89 mm Hg |
| Toprol XL | Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6 | Systolic Blood Pressure | -16.23 mm Hg |
| Toprol XL | Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6 | Diastolic Blood Pressure | -11.06 mm Hg |
Secondary
Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance 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.
Time frame: Baseline and Month 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Coreg CR | Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | -0.23 ng/mL |
| Toprol XL | Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | 0.20 ng/mL |
Secondary
Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance 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.
Time frame: Baseline and Month 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Coreg CR | Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | -1.21 uIU/mL |
| Toprol XL | Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | 1.35 uIU/mL |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance 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.
Time frame: Baseline and Month 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Coreg CR | Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | 0.94 mg/dL |
| Toprol XL | Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | 1.20 mg/dL |
Secondary
Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6
Manual physical examination. Change = Month 6 value minus Baseline value. (BPM=beats per minute)
Time frame: Baseline and Month 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Coreg CR | Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6 | -5.98 bpm |
| Toprol XL | Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6 | -6.07 bpm |
Secondary
Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance 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.
Time frame: Baseline and Month 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Coreg CR | Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | 0.01 Percent Change |
| Toprol XL | Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | 0.04 Percent Change |
Secondary
Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance 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.
Time frame: Baseline and Month 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Coreg CR | Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | 2.05 Percent Change |
| Toprol XL | Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | -4.14 Percent Change |
Secondary
Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6
Blood draw for hs-CRP. Change = Month 6 value minus Baseline value.
Time frame: Baseline and Month 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Coreg CR | Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6 | -1.76 mg/dL |
| Toprol XL | Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6 | 0.49 mg/dL |
Secondary
Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6
Blood draw for LpPLA2 activity. Change = Month 6 value minus Baseline value.
Time frame: Baseline and Month 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Coreg CR | Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6 | -2.38 mcmol/min/L |
| Toprol XL | Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6 | -2.23 mcmol/min/L |
Secondary
Change From Baseline in Weight by Treatment Group at Maintenance Month
Manual physical examination. Change = Month 6 value minus Baseline value.
Time frame: Baseline and Month 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Coreg CR | Change From Baseline in Weight by Treatment Group at Maintenance Month | 1.01 kg |
| Toprol XL | Change From Baseline in Weight by Treatment Group at Maintenance Month | 0.73 kg |