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
Allentown, Pennsylvania 18102
2337
mi
from 98109
Allentown, PA
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GSK Investigational Site
Altamonte Springs, Florida 32714
2540
mi
from 98109
Altamonte Springs, FL
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GSK Investigational Site
Atlantis, Florida 33462
2696
mi
from 98109
Atlantis, FL
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GSK Investigational Site
Baltimore, Maryland 21201
2327
mi
from 98109
Baltimore, MD
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GSK Investigational Site
Birmingham, Alabama 35249
2072
mi
from 98109
Birmingham, AL
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GSK Investigational Site
Buffalo, New York 14263
2110
mi
from 98109
Buffalo, NY
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GSK Investigational Site
Camden, New Jersey 08103
2376
mi
from 98109
Camden, NJ
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GSK Investigational Site
Camp Hill, Pennsylvania 17011
2282
mi
from 98109
Camp Hill, PA
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GSK Investigational Site
Chandler, Arizona 85224
1128
mi
from 98109
Chandler, AZ
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GSK Investigational Site
Cincinnati, Ohio 45229
1966
mi
from 98109
Cincinnati, OH
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GSK Investigational Site
Cleveland, Ohio 44195
2024
mi
from 98109
Cleveland, OH
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GSK Investigational Site
Colorado Springs, Colorado 80910
1070
mi
from 98109
Colorado Springs, CO
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GSK Investigational Site
Columbia, Maryland 21044
2318
mi
from 98109
Columbia, MD
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GSK Investigational Site
Columbia, South Carolina 29203
2316
mi
from 98109
Columbia, SC
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GSK Investigational Site
Danville, Virginia 24541
2296
mi
from 98109
Danville, VA
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GSK Investigational Site
Denver, Colorado 80206
1022
mi
from 98109
Denver, CO
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GSK Investigational Site
Doylestown, Pennsylvania 18901
2363
mi
from 98109
Doylestown, PA
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GSK Investigational Site
Edina, Minnesota 55435
1390
mi
from 98109
Edina, MN
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GSK Investigational Site
Evanston, Illinois 60201
1725
mi
from 98109
Evanston, IL
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GSK Investigational Site
Fayetteville, North Carolina 28304
2379
mi
from 98109
Fayetteville, NC
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GSK Investigational Site
Fort Wayne, Indiana 46825
1872
mi
from 98109
Fort Wayne, IN
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GSK Investigational Site
Fresno, California 93720
755
mi
from 98109
Fresno, CA
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GSK Investigational Site
Grand Rapids, Michigan 49546
1800
mi
from 98109
Grand Rapids, MI
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GSK Investigational Site
Greensboro, North Carolina 27403
2295
mi
from 98109
Greensboro, NC
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GSK Investigational Site
Greenville, South Carolina 29615
2226
mi
from 98109
Greenville, SC
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GSK Investigational Site
Greer, South Carolina 29651
2229
mi
from 98109
Greer, SC
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GSK Investigational Site
Hillsboro, Oregon 97123
149
mi
from 98109
Hillsboro, OR
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GSK Investigational Site
Houston, Texas 77030
1892
mi
from 98109
Houston, TX
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GSK Investigational Site
Indianapolis, Indiana 46202
1867
mi
from 98109
Indianapolis, IN
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GSK Investigational Site
Jacksonville, Florida 32207
2454
mi
from 98109
Jacksonville, FL
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GSK Investigational Site
Kingsport, Tennessee 37660
2150
mi
from 98109
Kingsport, TN
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GSK Investigational Site
Kissimmee, Florida 34741
2556
mi
from 98109
Kissimmee, FL
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GSK Investigational Site
Knoxville, Tennessee 37916
2110
mi
from 98109
Knoxville, TN
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GSK Investigational Site
Longwood, Florida 32779
2226
mi
from 98109
Longwood, FL
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GSK Investigational Site
Los Angeles, California 90025
960
mi
from 98109
Los Angeles, CA
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GSK Investigational Site
Mesa, Arizona 85206
1129
mi
from 98109
Mesa, AZ
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GSK Investigational Site
Miami, Florida 33136
2730
mi
from 98109
Miami, FL
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GSK Investigational Site
Milwaukee, Wisconsin 53215
1687
mi
from 98109
Milwaukee, WI
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GSK Investigational Site
Minneapolis, Minnesota 55404
1392
mi
from 98109
Minneapolis, MN
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GSK Investigational Site
Mobile, Alabama 36617
2148
mi
from 98109
Mobile, AL
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GSK Investigational Site
Nashville, Tennessee 37203
1971
mi
from 98109
Nashville, TN
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GSK Investigational Site
New York, New York 10032
2400
mi
from 98109
New York, NY
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GSK Investigational Site
Newark, Delaware 19713
2357
mi
from 98109
Newark, DE
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GSK Investigational Site
Ormond Beach, Florida 32174
2527
mi
from 98109
Ormond Beach, FL
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GSK Investigational Site
Palo Alto, California 94304
708
mi
from 98109
Palo Alto, CA
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GSK Investigational Site
Pembroke Pines, Florida 33028
2713
mi
from 98109
Pembroke Pines, FL
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GSK Investigational Site
Peoria, Arizona 85381
1102
mi
from 98109
Peoria, AZ
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GSK Investigational Site
Philadelphia, Pennsylvania 19104
2371
mi
from 98109
Philadelphia, PA
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GSK Investigational Site
Pikesville, Maryland 21215
2323
mi
from 98109
Pikesville, MD
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GSK Investigational Site
Pittsburgh, Pennsylvania 15213
2134
mi
from 98109
Pittsburgh, PA
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GSK Investigational Site
Portland, Oregon 97227
145
mi
from 98109
Portland, OR
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GSK Investigational Site
Poway, California 92064
1050
mi
from 98109
Poway, CA
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GSK Investigational Site
Roanoke, Virginia 24013
2246
mi
from 98109
Roanoke, VA
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GSK Investigational Site
Sacremento, California 95819
628
mi
from 98109
Sacremento, CA
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GSK Investigational Site
San Diego, California 92111
1058
mi
from 98109
San Diego, CA
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GSK Investigational Site
San Leandro, California 94578
686
mi
from 98109
San Leandro, CA
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GSK Investigational Site
Santa Ana, California 92705
987
mi
from 98109
Santa Ana, CA
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GSK Investigational Site
Scarborough, Maine 04074
2478
mi
from 98109
Scarborough, ME
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GSK Investigational Site
Scottsdale, Arizona 85259
1114
mi
from 98109
Scottsdale, AZ
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GSK Investigational Site
Springfield, Virginia 22151
2318
mi
from 98109
Springfield, VA
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GSK Investigational Site
Sun City, Arizona 85351
1101
mi
from 98109
Sun City, AZ
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GSK Investigational Site
Tacoma, Washington 98405
27
mi
from 98109
Tacoma, WA
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GSK Investigational Site
Vernon Hills, Illinois 60061
1707
mi
from 98109
Vernon Hills, IL
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GSK Investigational Site
Warwick, Rhode Island 02888
2488
mi
from 98109
Warwick, RI
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GSK Investigational Site
Washington, District of Columbia 20007
2322
mi
from 98109
Washington,
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GSK Investigational Site
West Grove, Pennsylvania 19390
2346
mi
from 98109
West Grove, PA
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GSK Investigational Site
Williamsville, New York 14221
2114
mi
from 98109
Williamsville, NY
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GSK Investigational Site
Winston-Salem, North Carolina 27103
2272
mi
from 98109
Winston-Salem, NC
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