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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00273052

Purpose

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	Intervention	Phase
Dyslipidaemia Hypertension	Drug: Carvedilol Phosphate modified release formulation Drug: metoprolol succinate	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Succinic acid Metoprolol Metoprolol Tartrate Carvedilol Metoprolol succinate Metoprolol fumarate Carvedilol phosphate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.

Secondary Outcome Measures:

Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
Blood draw for hs-CRP. 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 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
Blood draw for LpPLA2 activity. Change = Month 6 value minus Baseline value.
Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value.
Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
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.

Enrollment:	514
Study Start Date:	January 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 metoprolol succinate

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273052

Show 105 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00273052 History of Changes
Other Study ID Numbers:	COR103561
Study First Received:	January 5, 2006
Results First Received:	December 19, 2008
Last Updated:	August 11, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

hypertension

Additional relevant MeSH terms:

Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Metoprolol
Carvedilol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents

Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on May 24, 2012