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
Winston-Salem, North Carolina 27103
971
mi
from
Winston-Salem, NC
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GSK Investigational Site
Allentown, Pennsylvania 18102
1209
mi
from
Allentown, PA
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GSK Investigational Site
Altamonte Springs, Florida 32714
1134
mi
from
Altamonte Springs, FL
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GSK Investigational Site
Atlantis, Florida 33462
1287
mi
from
Atlantis, FL
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GSK Investigational Site
Baltimore, Maryland 21201
1148
mi
from
Baltimore, MD
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GSK Investigational Site
Birmingham, Alabama 35249
676
mi
from
Birmingham, AL
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GSK Investigational Site
Buffalo, New York 14263
1057
mi
from
Buffalo, NY
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GSK Investigational Site
Camden, New Jersey 08103
1227
mi
from
Camden, NJ
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GSK Investigational Site
Camp Hill, Pennsylvania 17011
1132
mi
from
Camp Hill, PA
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GSK Investigational Site
Chandler, Arizona 85224
846
mi
from
Chandler, AZ
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GSK Investigational Site
Cincinnati, Ohio 45229
727
mi
from
Cincinnati, OH
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GSK Investigational Site
Cleveland, Ohio 44195
898
mi
from
Cleveland, OH
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GSK Investigational Site
Colorado Springs, Colorado 80910
383
mi
from
Colorado Springs, CO
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GSK Investigational Site
Columbia, Maryland 21044
1134
mi
from
Columbia, MD
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GSK Investigational Site
Columbia, South Carolina 29203
969
mi
from
Columbia, SC
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GSK Investigational Site
Danville, Virginia 24541
1016
mi
from
Danville, VA
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GSK Investigational Site
Denver, Colorado 80206
407
mi
from
Denver, CO
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GSK Investigational Site
Doylestown, Pennsylvania 18901
1227
mi
from
Doylestown, PA
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GSK Investigational Site
Edina, Minnesota 55435
544
mi
from
Edina, MN
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GSK Investigational Site
Evanston, Illinois 60201
613
mi
from
Evanston, IL
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GSK Investigational Site
Fayetteville, North Carolina 28304
1067
mi
from
Fayetteville, NC
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GSK Investigational Site
Fort Wayne, Indiana 46825
716
mi
from
Fort Wayne, IN
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GSK Investigational Site
Fresno, California 93720
1205
mi
from
Fresno, CA
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GSK Investigational Site
Grand Rapids, Michigan 49546
737
mi
from
Grand Rapids, MI
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GSK Investigational Site
Greensboro, North Carolina 27403
999
mi
from
Greensboro, NC
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GSK Investigational Site
Greenville, South Carolina 29615
883
mi
from
Greenville, SC
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GSK Investigational Site
Greer, South Carolina 29651
888
mi
from
Greer, SC
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GSK Investigational Site
Hillsboro, Oregon 97123
1398
mi
from
Hillsboro, OR
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GSK Investigational Site
Houston, Texas 77030
572
mi
from
Houston, TX
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GSK Investigational Site
Indianapolis, Indiana 46202
643
mi
from
Indianapolis, IN
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GSK Investigational Site
Jacksonville, Florida 32207
1058
mi
from
Jacksonville, FL
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GSK Investigational Site
Kingsport, Tennessee 37660
843
mi
from
Kingsport, TN
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GSK Investigational Site
Kissimmee, Florida 34741
1149
mi
from
Kissimmee, FL
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GSK Investigational Site
Knoxville, Tennessee 37916
777
mi
from
Knoxville, TN
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GSK Investigational Site
Longwood, Florida 32779
815
mi
from
Longwood, FL
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GSK Investigational Site
Los Angeles, California 90025
1179
mi
from
Los Angeles, CA
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GSK Investigational Site
Mesa, Arizona 85206
834
mi
from
Mesa, AZ
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GSK Investigational Site
Miami, Florida 33136
1320
mi
from
Miami, FL
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GSK Investigational Site
Milwaukee, Wisconsin 53215
632
mi
from
Milwaukee, WI
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GSK Investigational Site
Minneapolis, Minnesota 55404
551
mi
from
Minneapolis, MN
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GSK Investigational Site
Mobile, Alabama 36617
737
mi
from
Mobile, AL
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GSK Investigational Site
Nashville, Tennessee 37203
618
mi
from
Nashville, TN
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GSK Investigational Site
New York, New York 10032
1290
mi
from
New York, NY
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GSK Investigational Site
Newark, Delaware 19713
1195
mi
from
Newark, DE
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GSK Investigational Site
Ormond Beach, Florida 32174
1126
mi
from
Ormond Beach, FL
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GSK Investigational Site
Palo Alto, California 94304
1330
mi
from
Palo Alto, CA
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GSK Investigational Site
Pembroke Pines, Florida 33028
1302
mi
from
Pembroke Pines, FL
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GSK Investigational Site
Peoria, Arizona 85381
856
mi
from
Peoria, AZ
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GSK Investigational Site
Philadelphia, Pennsylvania 19104
1223
mi
from
Philadelphia, PA
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GSK Investigational Site
Pikesville, Maryland 21215
1144
mi
from
Pikesville, MD
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GSK Investigational Site
Pittsburgh, Pennsylvania 15213
974
mi
from
Pittsburgh, PA
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GSK Investigational Site
Portland, Oregon 97227
1384
mi
from
Portland, OR
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GSK Investigational Site
Poway, California 92064
1129
mi
from
Poway, CA
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GSK Investigational Site
Roanoke, Virginia 24013
979
mi
from
Roanoke, VA
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GSK Investigational Site
Sacremento, California 95819
1280
mi
from
Sacremento, CA
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GSK Investigational Site
San Diego, California 92111
1139
mi
from
San Diego, CA
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GSK Investigational Site
San Leandro, California 94578
1324
mi
from
San Leandro, CA
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GSK Investigational Site
Santa Ana, California 92705
1155
mi
from
Santa Ana, CA
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GSK Investigational Site
Scarborough, Maine 04074
1485
mi
from
Scarborough, ME
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GSK Investigational Site
Scottsdale, Arizona 85259
834
mi
from
Scottsdale, AZ
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GSK Investigational Site
Springfield, Virginia 22151
1119
mi
from
Springfield, VA
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GSK Investigational Site
Sun City, Arizona 85351
859
mi
from
Sun City, AZ
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GSK Investigational Site
Tacoma, Washington 98405
1408
mi
from
Tacoma, WA
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GSK Investigational Site
Vernon Hills, Illinois 60061
605
mi
from
Vernon Hills, IL
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GSK Investigational Site
Warwick, Rhode Island 02888
1423
mi
from
Warwick, RI
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GSK Investigational Site
Washington, District of Columbia 20007
1127
mi
from
Washington,
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GSK Investigational Site
West Grove, Pennsylvania 19390
1190
mi
from
West Grove, PA
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GSK Investigational Site
Williamsville, New York 14221
1064
mi
from
Williamsville, NY
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