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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Carvedilol Phosphate modified release formulation; Drug: metoprolol succinate

• Registration Number: NCT00273052
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-01-05
• Study First Submitted: 2006-01-05
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-09
• Primary Completion: 2007-12-01
• Study Completion: 2007-12-28
• Results First Submitted: 2008-12-19
• Results First Submitted QC: 2010-01-06
• Results First Posted: 2010-02-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 514

Inclusion Criteria

• Documented history of hypertension
• Triglycerides of 120-400 mg/mL
• LDLc levels not requiring lipid lowering medication.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carvedilol Phosphate modified release formulation	Carvedilol Phosphate modified release formulation	-
metoprolol succinate	metoprolol succinate	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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 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 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 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 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 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 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 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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇷 Rio Piedras, Puerto Rico