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
Palo Alto, California 94304
2102
mi
from 43215
Palo Alto, CA
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GSK Investigational Site
Allentown, Pennsylvania 18102
400
mi
from 43215
Allentown, PA
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GSK Investigational Site
Altamonte Springs, Florida 32714
786
mi
from 43215
Altamonte Springs, FL
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GSK Investigational Site
Atlantis, Florida 33462
939
mi
from 43215
Atlantis, FL
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GSK Investigational Site
Baltimore, Maryland 21201
343
mi
from 43215
Baltimore, MD
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GSK Investigational Site
Birmingham, Alabama 35249
493
mi
from 43215
Birmingham, AL
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GSK Investigational Site
Buffalo, New York 14263
295
mi
from 43215
Buffalo, NY
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GSK Investigational Site
Camden, New Jersey 08103
418
mi
from 43215
Camden, NJ
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GSK Investigational Site
Camp Hill, Pennsylvania 17011
323
mi
from 43215
Camp Hill, PA
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GSK Investigational Site
Chandler, Arizona 85224
1655
mi
from 43215
Chandler, AZ
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GSK Investigational Site
Cincinnati, Ohio 45229
96
mi
from 43215
Cincinnati, OH
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GSK Investigational Site
Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
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GSK Investigational Site
Colorado Springs, Colorado 80910
1161
mi
from 43215
Colorado Springs, CO
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GSK Investigational Site
Columbia, Maryland 21044
331
mi
from 43215
Columbia, MD
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GSK Investigational Site
Columbia, South Carolina 29203
418
mi
from 43215
Columbia, SC
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GSK Investigational Site
Danville, Virginia 24541
305
mi
from 43215
Danville, VA
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GSK Investigational Site
Denver, Colorado 80206
1160
mi
from 43215
Denver, CO
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GSK Investigational Site
Doylestown, Pennsylvania 18901
417
mi
from 43215
Doylestown, PA
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GSK Investigational Site
Edina, Minnesota 55435
624
mi
from 43215
Edina, MN
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GSK Investigational Site
Evanston, Illinois 60201
283
mi
from 43215
Evanston, IL
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GSK Investigational Site
Fayetteville, North Carolina 28304
408
mi
from 43215
Fayetteville, NC
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GSK Investigational Site
Fort Wayne, Indiana 46825
136
mi
from 43215
Fort Wayne, IN
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GSK Investigational Site
Fresno, California 93720
1986
mi
from 43215
Fresno, CA
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GSK Investigational Site
Grand Rapids, Michigan 49546
242
mi
from 43215
Grand Rapids, MI
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GSK Investigational Site
Greensboro, North Carolina 27403
320
mi
from 43215
Greensboro, NC
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GSK Investigational Site
Greenville, South Carolina 29615
353
mi
from 43215
Greenville, SC
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GSK Investigational Site
Greer, South Carolina 29651
350
mi
from 43215
Greer, SC
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GSK Investigational Site
Hillsboro, Oregon 97123
2042
mi
from 43215
Hillsboro, OR
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GSK Investigational Site
Houston, Texas 77030
995
mi
from 43215
Houston, TX
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GSK Investigational Site
Indianapolis, Indiana 46202
166
mi
from 43215
Indianapolis, IN
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GSK Investigational Site
Jacksonville, Florida 32207
672
mi
from 43215
Jacksonville, FL
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GSK Investigational Site
Kingsport, Tennessee 37660
237
mi
from 43215
Kingsport, TN
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GSK Investigational Site
Kissimmee, Florida 34741
810
mi
from 43215
Kissimmee, FL
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GSK Investigational Site
Knoxville, Tennessee 37916
281
mi
from 43215
Knoxville, TN
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GSK Investigational Site
Longwood, Florida 32779
686
mi
from 43215
Longwood, FL
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GSK Investigational Site
Los Angeles, California 90025
1983
mi
from 43215
Los Angeles, CA
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GSK Investigational Site
Mesa, Arizona 85206
1644
mi
from 43215
Mesa, AZ
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GSK Investigational Site
Miami, Florida 33136
992
mi
from 43215
Miami, FL
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GSK Investigational Site
Milwaukee, Wisconsin 53215
329
mi
from 43215
Milwaukee, WI
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GSK Investigational Site
Minneapolis, Minnesota 55404
624
mi
from 43215
Minneapolis, MN
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GSK Investigational Site
Mobile, Alabama 36617
699
mi
from 43215
Mobile, AL
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GSK Investigational Site
Nashville, Tennessee 37203
333
mi
from 43215
Nashville, TN
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GSK Investigational Site
New York, New York 10032
481
mi
from 43215
New York, NY
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GSK Investigational Site
Newark, Delaware 19713
388
mi
from 43215
Newark, DE
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GSK Investigational Site
Ormond Beach, Florida 32174
746
mi
from 43215
Ormond Beach, FL
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GSK Investigational Site
Pembroke Pines, Florida 33028
975
mi
from 43215
Pembroke Pines, FL
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GSK Investigational Site
Peoria, Arizona 85381
1666
mi
from 43215
Peoria, AZ
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GSK Investigational Site
Philadelphia, Pennsylvania 19104
414
mi
from 43215
Philadelphia, PA
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GSK Investigational Site
Pikesville, Maryland 21215
340
mi
from 43215
Pikesville, MD
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GSK Investigational Site
Pittsburgh, Pennsylvania 15213
165
mi
from 43215
Pittsburgh, PA
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GSK Investigational Site
Portland, Oregon 97227
2026
mi
from 43215
Portland, OR
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GSK Investigational Site
Poway, California 92064
1938
mi
from 43215
Poway, CA
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GSK Investigational Site
Roanoke, Virginia 24013
250
mi
from 43215
Roanoke, VA
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GSK Investigational Site
Sacremento, California 95819
2041
mi
from 43215
Sacremento, CA
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GSK Investigational Site
San Diego, California 92111
1948
mi
from 43215
San Diego, CA
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GSK Investigational Site
San Leandro, California 94578
2093
mi
from 43215
San Leandro, CA
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GSK Investigational Site
Santa Ana, California 92705
1960
mi
from 43215
Santa Ana, CA
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GSK Investigational Site
Scarborough, Maine 04074
696
mi
from 43215
Scarborough, ME
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GSK Investigational Site
Scottsdale, Arizona 85259
1644
mi
from 43215
Scottsdale, AZ
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GSK Investigational Site
Springfield, Virginia 22151
322
mi
from 43215
Springfield, VA
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GSK Investigational Site
Sun City, Arizona 85351
1669
mi
from 43215
Sun City, AZ
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GSK Investigational Site
Tacoma, Washington 98405
2013
mi
from 43215
Tacoma, WA
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GSK Investigational Site
Vernon Hills, Illinois 60061
300
mi
from 43215
Vernon Hills, IL
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GSK Investigational Site
Warwick, Rhode Island 02888
618
mi
from 43215
Warwick, RI
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GSK Investigational Site
Washington, District of Columbia 20007
328
mi
from 43215
Washington,
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GSK Investigational Site
West Grove, Pennsylvania 19390
381
mi
from 43215
West Grove, PA
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GSK Investigational Site
Williamsville, New York 14221
303
mi
from 43215
Williamsville, NY
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GSK Investigational Site
Winston-Salem, North Carolina 27103
307
mi
from 43215
Winston-Salem, NC
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