The CLEVER Study - Coreg And Left Ventricular Mass Regression



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:January 2005
End Date:August 2008

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Trial Summary
Trial Overview
Inclusion Criteria

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).

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.

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).

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.
We found this trial at
68
sites
GSK Investigational Site
Colorado Springs, Colorado 80910
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Allentown, Pennsylvania 18102
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Allentown, PA
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Altamonte Springs, Florida 32714
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Altamonte Springs, FL
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Atlantis, Florida 33462
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Atlantis, FL
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Baltimore, Maryland 21201
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Baltimore, MD
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GSK Investigational Site
Birmingham, Alabama 35249
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Birmingham, AL
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GSK Investigational Site
Buffalo, New York 14263
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Buffalo, NY
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Camden, New Jersey 08103
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Camden, NJ
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Camp Hill, Pennsylvania 17011
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Camp Hill, PA
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Chandler, Arizona 85224
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Chandler, AZ
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GSK Investigational Site
Cincinnati, Ohio 45229
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Cincinnati, OH
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Cleveland, Ohio 44195
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Cleveland, OH
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Columbia, Maryland 21044
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Columbia, MD
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GSK Investigational Site
Columbia, South Carolina 29203
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Columbia, SC
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GSK Investigational Site
Danville, Virginia 24541
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Danville, VA
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GSK Investigational Site
Denver, Colorado 80206
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Denver, CO
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Doylestown, Pennsylvania 18901
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Doylestown, PA
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Edina, Minnesota 55435
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Edina, MN
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Evanston, Illinois 60201
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Evanston, IL
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Fayetteville, North Carolina 28304
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Fayetteville, NC
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GSK Investigational Site
Fort Wayne, Indiana 46825
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Fort Wayne, IN
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Fresno, California 93720
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Fresno, CA
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GSK Investigational Site
Grand Rapids, Michigan 49546
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Grand Rapids, MI
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Greensboro, North Carolina 27403
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Greensboro, NC
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GSK Investigational Site
Greenville, South Carolina 29615
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Greenville, SC
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Greer, South Carolina 29651
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Greer, SC
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Hillsboro, Oregon 97123
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Hillsboro, OR
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Jacksonville, Florida 32207
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Jacksonville, FL
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Kingsport, Tennessee 37660
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Kingsport, TN
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Kissimmee, Florida 34741
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Kissimmee, FL
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GSK Investigational Site
Knoxville, Tennessee 37916
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Knoxville, TN
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Longwood, Florida 32779
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Longwood, FL
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Los Angeles, California 90025
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Los Angeles, CA
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Mesa, Arizona 85206
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Mesa, AZ
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Miami, Florida 33136
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Miami, FL
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Milwaukee, Wisconsin 53215
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Milwaukee, WI
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GSK Investigational Site
Minneapolis, Minnesota 55404
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Minneapolis, MN
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GSK Investigational Site
Mobile, Alabama 36617
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Mobile, AL
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GSK Investigational Site
Nashville, Tennessee 37203
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Nashville, TN
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GSK Investigational Site
New York, New York 10032
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New York, NY
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GSK Investigational Site
Newark, Delaware 19713
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Newark, DE
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Ormond Beach, Florida 32174
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Ormond Beach, FL
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GSK Investigational Site
Palo Alto, California 94304
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Palo Alto, CA
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Pembroke Pines, Florida 33028
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Pembroke Pines, FL
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GSK Investigational Site
Peoria, Arizona 85381
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Peoria, AZ
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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GSK Investigational Site
Pikesville, Maryland 21215
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Pikesville, MD
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Pittsburgh, Pennsylvania 15213
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GSK Investigational Site
Portland, Oregon 97227
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Portland, OR
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Poway, California 92064
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Poway, CA
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Roanoke, Virginia 24013
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Roanoke, VA
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Sacremento, California 95819
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Sacremento, CA
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San Diego, California 92111
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San Diego, CA
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San Leandro, California 94578
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San Leandro, CA
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Santa Ana, California 92705
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Santa Ana, CA
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Scarborough, Maine 04074
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Scarborough, ME
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Scottsdale, Arizona 85259
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Scottsdale, AZ
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Springfield, Virginia 22151
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Springfield, VA
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Sun City, Arizona 85351
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Sun City, AZ
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GSK Investigational Site
Tacoma, Washington 98405
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Tacoma, WA
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GSK Investigational Site
Vernon Hills, Illinois 60061
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Vernon Hills, IL
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GSK Investigational Site
Warwick, Rhode Island 02888
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Warwick, RI
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Washington, District of Columbia 20007
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West Grove, Pennsylvania 19390
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West Grove, PA
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GSK Investigational Site
Williamsville, New York 14221
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Williamsville, NY
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GSK Investigational Site
Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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