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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Carvedilol Phosphate modified release formulation
* Drug: metoprolol succinate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carvedilol Phosphate modified release formulation<br> | Drug: Carvedilol Phosphate modified release formulation<br> <br> |
| Active Comparator: metoprolol succinate<br> | Drug: metoprolol succinate<br> <br> * Other names: Carvedilol Phosphate modified release formulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Month 6 | 
| 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. | Baseline and Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Month 6 | 
| 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. | Baseline and Month 6 | 
| 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. | Baseline and Month 6 | 
| 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) | Baseline and Month 6 | 
| Change From Baseline in Weight by Treatment Group at Maintenance Month | Manual physical examination. Change = Month 6 value minus Baseline value. | 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 | 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. | 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 | Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value. | Baseline and Month 6 | 
| 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. | Baseline and Month 6 | 
| 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. | Baseline and Month 6 | 
| 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. | Baseline and Month 6 | 
| 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. | Baseline and Month 6 | 
| 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. | Baseline and Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension