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
Pikesville, Maryland 21215
358
mi
from 02139
Pikesville, MD
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GSK Investigational Site
Allentown, Pennsylvania 18102
256
mi
from 02139
Allentown, PA
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GSK Investigational Site
Altamonte Springs, Florida 32714
1108
mi
from 02139
Altamonte Springs, FL
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GSK Investigational Site
Atlantis, Florida 33462
1202
mi
from 02139
Atlantis, FL
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GSK Investigational Site
Baltimore, Maryland 21201
357
mi
from 02139
Baltimore, MD
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GSK Investigational Site
Birmingham, Alabama 35249
1052
mi
from 02139
Birmingham, AL
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GSK Investigational Site
Buffalo, New York 14263
396
mi
from 02139
Buffalo, NY
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GSK Investigational Site
Camden, New Jersey 08103
267
mi
from 02139
Camden, NJ
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GSK Investigational Site
Camp Hill, Pennsylvania 17011
335
mi
from 02139
Camp Hill, PA
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GSK Investigational Site
Chandler, Arizona 85224
2286
mi
from 02139
Chandler, AZ
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GSK Investigational Site
Cincinnati, Ohio 45229
733
mi
from 02139
Cincinnati, OH
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GSK Investigational Site
Cleveland, Ohio 44195
543
mi
from 02139
Cleveland, OH
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GSK Investigational Site
Colorado Springs, Colorado 80910
1771
mi
from 02139
Colorado Springs, CO
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GSK Investigational Site
Columbia, Maryland 21044
372
mi
from 02139
Columbia, MD
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GSK Investigational Site
Columbia, South Carolina 29203
783
mi
from 02139
Columbia, SC
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GSK Investigational Site
Danville, Virginia 24541
595
mi
from 02139
Danville, VA
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GSK Investigational Site
Denver, Colorado 80206
1761
mi
from 02139
Denver, CO
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GSK Investigational Site
Doylestown, Pennsylvania 18901
252
mi
from 02139
Doylestown, PA
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GSK Investigational Site
Edina, Minnesota 55435
1121
mi
from 02139
Edina, MN
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GSK Investigational Site
Evanston, Illinois 60201
847
mi
from 02139
Evanston, IL
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GSK Investigational Site
Fayetteville, North Carolina 28304
655
mi
from 02139
Fayetteville, NC
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GSK Investigational Site
Fort Wayne, Indiana 46825
726
mi
from 02139
Fort Wayne, IN
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GSK Investigational Site
Fresno, California 93720
2582
mi
from 02139
Fresno, CA
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GSK Investigational Site
Grand Rapids, Michigan 49546
734
mi
from 02139
Grand Rapids, MI
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GSK Investigational Site
Greensboro, North Carolina 27403
637
mi
from 02139
Greensboro, NC
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GSK Investigational Site
Greenville, South Carolina 29615
795
mi
from 02139
Greenville, SC
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GSK Investigational Site
Greer, South Carolina 29651
788
mi
from 02139
Greer, SC
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GSK Investigational Site
Hillsboro, Oregon 97123
2545
mi
from 02139
Hillsboro, OR
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GSK Investigational Site
Houston, Texas 77030
1605
mi
from 02139
Houston, TX
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GSK Investigational Site
Indianapolis, Indiana 46202
802
mi
from 02139
Indianapolis, IN
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GSK Investigational Site
Jacksonville, Florida 32207
1017
mi
from 02139
Jacksonville, FL
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GSK Investigational Site
Kingsport, Tennessee 37660
730
mi
from 02139
Kingsport, TN
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GSK Investigational Site
Kissimmee, Florida 34741
1130
mi
from 02139
Kissimmee, FL
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GSK Investigational Site
Knoxville, Tennessee 37916
816
mi
from 02139
Knoxville, TN
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GSK Investigational Site
Longwood, Florida 32779
1187
mi
from 02139
Longwood, FL
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GSK Investigational Site
Los Angeles, California 90025
2599
mi
from 02139
Los Angeles, CA
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GSK Investigational Site
Mesa, Arizona 85206
2275
mi
from 02139
Mesa, AZ
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GSK Investigational Site
Miami, Florida 33136
1256
mi
from 02139
Miami, FL
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GSK Investigational Site
Milwaukee, Wisconsin 53215
855
mi
from 02139
Milwaukee, WI
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GSK Investigational Site
Minneapolis, Minnesota 55404
1118
mi
from 02139
Minneapolis, MN
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GSK Investigational Site
Mobile, Alabama 36617
1235
mi
from 02139
Mobile, AL
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GSK Investigational Site
Nashville, Tennessee 37203
940
mi
from 02139
Nashville, TN
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GSK Investigational Site
New York, New York 10032
180
mi
from 02139
New York, NY
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GSK Investigational Site
Newark, Delaware 19713
304
mi
from 02139
Newark, DE
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GSK Investigational Site
Ormond Beach, Florida 32174
1060
mi
from 02139
Ormond Beach, FL
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GSK Investigational Site
Palo Alto, California 94304
2689
mi
from 02139
Palo Alto, CA
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GSK Investigational Site
Pembroke Pines, Florida 33028
1244
mi
from 02139
Pembroke Pines, FL
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GSK Investigational Site
Peoria, Arizona 85381
2295
mi
from 02139
Peoria, AZ
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GSK Investigational Site
Philadelphia, Pennsylvania 19104
270
mi
from 02139
Philadelphia, PA
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GSK Investigational Site
Pittsburgh, Pennsylvania 15213
477
mi
from 02139
Pittsburgh, PA
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GSK Investigational Site
Portland, Oregon 97227
2530
mi
from 02139
Portland, OR
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GSK Investigational Site
Poway, California 92064
2561
mi
from 02139
Poway, CA
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GSK Investigational Site
Roanoke, Virginia 24013
585
mi
from 02139
Roanoke, VA
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GSK Investigational Site
Sacremento, California 95819
2620
mi
from 02139
Sacremento, CA
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GSK Investigational Site
San Diego, California 92111
2572
mi
from 02139
San Diego, CA
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GSK Investigational Site
San Leandro, California 94578
2677
mi
from 02139
San Leandro, CA
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GSK Investigational Site
Santa Ana, California 92705
2579
mi
from 02139
Santa Ana, CA
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GSK Investigational Site
Scarborough, Maine 04074
93
mi
from 02139
Scarborough, ME
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GSK Investigational Site
Scottsdale, Arizona 85259
2274
mi
from 02139
Scottsdale, AZ
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GSK Investigational Site
Springfield, Virginia 22151
403
mi
from 02139
Springfield, VA
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GSK Investigational Site
Sun City, Arizona 85351
2298
mi
from 02139
Sun City, AZ
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GSK Investigational Site
Tacoma, Washington 98405
2494
mi
from 02139
Tacoma, WA
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GSK Investigational Site
Vernon Hills, Illinois 60061
860
mi
from 02139
Vernon Hills, IL
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GSK Investigational Site
Warwick, Rhode Island 02888
45
mi
from 02139
Warwick, RI
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GSK Investigational Site
Washington, District of Columbia 20007
392
mi
from 02139
Washington,
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GSK Investigational Site
West Grove, Pennsylvania 19390
302
mi
from 02139
West Grove, PA
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GSK Investigational Site
Williamsville, New York 14221
389
mi
from 02139
Williamsville, NY
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GSK Investigational Site
Winston-Salem, North Carolina 27103
658
mi
from 02139
Winston-Salem, NC
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