COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria

This study has been completed.

First Received: July 22, 2005 Last Updated: October 13, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00123903

Purpose

This study was designed to determine whether COREG MR is more effective than TOPROL-XL in reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood pressure and microalbuminuria.

Condition	Intervention	Phase
Hypertension Microalbuminuria	Drug: metoprolol xl Drug: carvedilol MR Drug: lisinopril	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Positive-Controlled, Multicenter Study Comparing the Efficacy of Carvedilol Phosphate Modified Release Formulation (COREG MR) and Metoprolol Succinate Extended Release (TOPROL-XL) on the Reduction of Microalbuminuria in Patients With Hypertension and Microalbuminuria

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Urine and Urination

Drug Information available for: Metoprolol Metoprolol Tartrate Carvedilol Lisinopril Metoprolol succinate Metoprolol fumarate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Urine albumin:creatinine ratio

Secondary Outcome Measures:

Percentage of subjects who will progress to macroalbuminuria or revert to normoalbuminuria.
Lipid profile, C-reactive protein, blood pressure and heart rate.

Estimated Enrollment:	1220
Study Start Date:	July 2005

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.
Must have been taking an ACE (angiotensin converting enzyme) inhibitor either alone or as part of an antihypertensive regimen for at least 8 weeks.
Persistent microalbuminuria.

Exclusion criteria:

History of heart attack, stroke, congestive heart failure, arrhythmia, type 1 or uncontrolled type 2 diabetes mellitus, liver or renal disease.
Has been taking any non-ocular beta-blockers for any indication within three months prior to Pre-screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123903

Show 76 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:	COR103560
Study First Received:	July 22, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00123903 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

urine albumin:creatinine ratio
microalbuminuria
hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Signs and Symptoms
Urologic Diseases
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Carvedilol
Sympatholytics

Albuminuria
Urination Disorders
Lisinopril
Vascular Diseases
Enzyme Inhibitors
Adrenergic alpha-Antagonists
Cardiovascular Agents
Metoprolol
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Urological Manifestations
Proteinuria
Autonomic Agents

ClinicalTrials.gov processed this record on February 08, 2010