The CLEVER Study - Coreg And Left Ventricular Mass Regression - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00108082

Purpose

This study is designed to compare the effects of COREG MR (carvedilol modified release formulation) to atenolol on indices of left ventricular dimensions when added to standardized angiotensin converting enzyme (ACE) inhibition, and to the effect of ACE inhibition alone. Subjects with LVH (left ventricular hypertrophy) and hypertension will be studied. The primary endpoint will be the change in left ventricular mass index (LVMI) characterized by magnetic resonance imaging (MRI) following 12 months of treatment. Secondary endpoints include the change in LV (left ventricular) mass, LV wall thickness, diastolic left ventricular filling parameters, and left ventricular ejection fraction by echocardiographic methods at Treatment Month 12. Composite outcomes and individual event data will also be evaluated by treatment group.

Condition	Intervention	Phase
Hypertension Left Ventricular Hypertrophy	Drug: carvedilol MR Drug: atenolol Drug: lisinopril	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure MRI Scans

Drug Information available for: Atenolol Carvedilol Lisinopril

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Magnetic Resonance Imaging (MRI) at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the Last Observation Carried Forward [LOCF] analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was available) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed B-type Natriuretic Peptide (BNP) at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF was used ] [ Designated as safety issue: No ]
Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed C-Reactive Protein (CRP) at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF was used) ] [ Designated as safety issue: No ]
Percentage Change From Baseline in Log Transformed Lipid Parameters at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF was used) ] [ Designated as safety issue: No ]
Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed Albumin Creatinine Ratio (ACR) at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF was used) ] [ Designated as safety issue: No ]

Enrollment:	413
Study Start Date:	January 2005

Detailed Description:

A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Modified Release Formulation (COREG MR) and Atenolol in Combination with and Compared to an Angiotensin Converting Enzyme Inhibitor (Lisinopril) on Left Ventricular Mass Regression in Hypertensive Patients with Left Ventricular Hypertrophy (LVH).

Eligibility

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

Criteria

Inclusion criteria:

Stage 1 or Stage 2 hypertension.
Left ventricular hypertrophy.

Exclusion criteria:

In atrial fibrillation.
Takes beta-blocker for MI (myocardial infarction) or arrhythmia.
Has uncontrolled diabetes, uncontrollable or symptomatic arrhythmias, unstable angina, second or third degree heart block, history of MI, COPD (chronic obstructive pulmonary disease), liver or kidney disease.
Uses beta-2-agonists.
Unable to undergo MRI (magnetic resonance imaging).
Females of childbearing potential.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108082

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Locations

United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35249
GSK Investigational Site
Mobile, Alabama, United States, 36608
GSK Investigational Site
Birmingham, Alabama, United States, 35235
United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 77030
GSK Investigational Site
Gilbert, Arizona, United States, 85296
GSK Investigational Site
Sun City, Arizona, United States, 85351
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
GSK Investigational Site
Scottsdale, Arizona, United States, 85260
United States, California
GSK Investigational Site
Poway, California, United States, 92064
GSK Investigational Site
Los Angeles, California, United States, 90048
GSK Investigational Site
Palo Alto, California, United States, 94301
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
Santa Ana, California, United States, 92705
GSK Investigational Site
San Diego, California, United States, 92120
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80204
GSK Investigational Site
Colorado Springs, Colorado, United States, 80919
GSK Investigational Site
Denver, Colorado, United States, 80218
United States, Delaware
GSK Investigational Site
Newark, Delaware, United States, 19718
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20037
GSK Investigational Site
Washington, District of Columbia, United States, 20422
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32209
GSK Investigational Site
Ormond Beach, Florida, United States, 32714
GSK Investigational Site
Atlantis, Florida, United States, 33462
GSK Investigational Site
Longwood, Florida, United States, 32779
GSK Investigational Site
Miami, Florida, United States, 33156
GSK Investigational Site
Kissimmee, Florida, United States, 34741
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
GSK Investigational Site
Fort Wayne, Indiana, United States, 46804
United States, Maine
GSK Investigational Site
Scarborough, Maine, United States, 04074
United States, Maryland
GSK Investigational Site
Pikesville, Maryland, United States, 21215
United States, Michigan
GSK Investigational Site
Grand Rapids, Michigan, United States, 49525
United States, Minnesota
GSK Investigational Site
Edina, Minnesota, United States, 55435
United States, New Jersey
GSK Investigational Site
Camden, New Jersey, United States, 08103
United States, New York
GSK Investigational Site
Williamsville, New York, United States, 14221
GSK Investigational Site
New York, New York, United States, 10128
GSK Investigational Site
New York, New York, United States, 10011
GSK Investigational Site
Buffalo, New York, United States, 14215
United States, North Carolina
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45224
United States, Oregon
GSK Investigational Site
Hillsboro, Oregon, United States, 97123-4117
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
GSK Investigational Site
Doylestown, Pennsylvania, United States, 18901
GSK Investigational Site
Camp Hill, Pennsylvania, United States, 17011
GSK Investigational Site
West Grove, Pennsylvania, United States, 19390
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
GSK Investigational Site
Greer, South Carolina, United States, 29651
GSK Investigational Site
Greenville, South Carolina, United States, 29615
GSK Investigational Site
Columbia, South Carolina, United States, 29204
United States, Tennessee
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
GSK Investigational Site
Springfield, Virginia, United States, 22151
GSK Investigational Site
Roanoke, Virginia, United States, 24014
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215

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:	COR100216
Study First Received:	April 13, 2005
Results First Received:	August 13, 2009
Last Updated:	September 30, 2009
ClinicalTrials.gov Identifier:	NCT00108082 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

left ventricular hypertrophy (LVH)
left ventricular mass regression
left ventricular mass index (LVMI)hypertension
cardiac MRI
echocardiogram

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Carvedilol
Hypertrophy, Left Ventricular
Sympatholytics

Heart Diseases
Lisinopril
Vascular Diseases
Enzyme Inhibitors
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Hypertrophy
Autonomic Agents
Adrenergic Antagonists
Peripheral Nervous System Agents
Atenolol

ClinicalTrials.gov processed this record on November 27, 2009