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

This study has been completed.

First Received: January 5, 2006 Last Updated: October 15, 2008 History of Changes

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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: Metoprolol Metoprolol Tartrate Lipids Carvedilol Succinic acid Metoprolol succinate Metoprolol fumarate Carvedilol phosphate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline to 6 months in HDL-C or triglycerides levels. [ Time Frame: 6 Months ]

Secondary Outcome Measures:

Change from baseline to 6 months in lipid profile, glycemic parameters, C-reactive protein, LpPLA2, blood pressure and heart rate. [ Time Frame: 6 months ]

Enrollment:	514
Study Start Date:	January 2006

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 106 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	COR103561
Study First Received:	January 5, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00273052 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Dyslipidemias
Carvedilol
Sympatholytics
Metabolic Diseases

Vascular Diseases
Cardiovascular Agents
Adrenergic alpha-Antagonists
Metoprolol
Antihypertensive Agents
Pharmacologic Actions
Autonomic Agents
Metoprolol succinate
Adrenergic Antagonists
Peripheral Nervous System Agents
Lipid Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009