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

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Other Names:

metoprolol xl
carvedilol MR
lisinopril

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:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00123903 History of Changes
Other Study ID Numbers:	COR103560
Study First Received:	July 22, 2005
Last Updated:	October 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

urine albumin:creatinine ratio
microalbuminuria
hypertension

Additional relevant MeSH terms:

Hypertension
Albuminuria
Vascular Diseases
Cardiovascular Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Metoprolol
Carvedilol
Lisinopril
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

ClinicalTrials.gov processed this record on February 09, 2012