Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)



Status:Terminated
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:45 - Any
Updated:4/23/2016
Start Date:June 2012
End Date:August 2015

Use our guide to learn which trials are right for you!

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR

The purpose of this study is to determine the effects of NB relative to placebo on major
adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial
infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk
of having these events because they have diabetes and/or other cardiovascular risk factors.


Inclusion Criteria:

1. ≥50 years of age (women) or ≥45 years of age (men)

2. Body mass index (BMI) ≥27 kg/m2 and ≤50 kg/m2

3. Waist circumference ≥88 cm (women) or ≥102 cm (men)

4. At increased risk of adverse cardiovascular outcomes:

- Cardiovascular disease (confirmed diagnosis or at high likelihood of
cardiovascular disease) with at least one of the following:

- History of documented myocardial infarction >3 months prior to screening

- History of coronary revascularization

- History of carotid or peripheral revascularization

- Angina with ischemic changes (resting ECG), ECG changes on a graded
exercise test (GXT), or positive cardiac imaging study

- Ankle brachial index <0.9 (by simple palpation) within prior 2 years

- ≥50% stenosis of a coronary, carotid, or lower extremity artery within
prior 2 years

AND/OR

- Type 2 diabetes mellitus with at least 2 of the following:

- Hypertension (controlled with or without pharmacotherapy at <145/95 mm Hg)

- Dyslipidemia requiring pharmacotherapy

- Documented low HDL cholesterol (<50 mg/dL in women or <40 mg/dL in men) within
prior 12 months

- Current tobacco smoker

Exclusion Criteria:

1. Myocardial infarction within 3 months prior to screening

2. Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading
scheme

3. Clinical history of cerebrovascular disease (stroke)

4. History of tachyarrhythmia other than sinus tachycardia

5. Planned bariatric surgery, cardiac surgery, or coronary angioplasty

6. History of seizures (including febrile seizures), cranial trauma, or other conditions
that predispose the subject to seizures

7. History of mania or current diagnosis of active psychosis, active bulimia or anorexia
nervosa (binge eating disorder is not exclusionary)

8. Any condition with life expectancy anticipated to be less than 4 years (e.g.,
congestive heart failure NYHA Class 3 or 4)
We found this trial at
224
sites
364
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
2040
mi
from 91732
Akron, OH
Click here to add this to my saved trials
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
1494
mi
from 91732
Alexandria, LA
Click here to add this to my saved trials
2281
mi
from 91732
Alexandria, VA
Click here to add this to my saved trials
2203
mi
from 91732
Altoona, PA
Click here to add this to my saved trials
1430
mi
from 91732
Ames, IA
Click here to add this to my saved trials
16
mi
from 91732
Anaheim, CA
Click here to add this to my saved trials
2008
mi
from 91732
Anderson, SC
Click here to add this to my saved trials
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
2615
mi
from 91732
Auburn, ME
Click here to add this to my saved trials
1904
mi
from 91732
Austell, GA
Click here to add this to my saved trials
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
2686
mi
from 91732
Bangor, ME
Click here to add this to my saved trials
1589
mi
from 91732
Baton Rouge, LA
Click here to add this to my saved trials
2041
mi
from 91732
Beachwood, OH
Click here to add this to my saved trials
1423
mi
from 91732
Beaumont, TX
Click here to add this to my saved trials
2376
mi
from 91732
Belvidere, NJ
Click here to add this to my saved trials
2386
mi
from 91732
Bensalem, PA
Click here to add this to my saved trials
1955
mi
from 91732
Bingham Farms, MI
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
1769
mi
from 91732
Bloomington, IN
Click here to add this to my saved trials
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
577
mi
from 91732
Bountiful, UT
Click here to add this to my saved trials
2309
mi
from 91732
Boynton Beach, FL
Click here to add this to my saved trials
2016
mi
from 91732
Bristol, TN
Click here to add this to my saved trials
2581
mi
from 91732
Brockton, MA
Click here to add this to my saved trials
2436
mi
from 91732
Bronx, NY
Click here to add this to my saved trials
2126
mi
from 91732
Brooksville, FL
Click here to add this to my saved trials
1780
mi
from 91732
Brownsburg, IN
Click here to add this to my saved trials
873
mi
from 91732
Butte, MT
Click here to add this to my saved trials
364
mi
from 91732
Carmichael, CA
Click here to add this to my saved trials
2210
mi
from 91732
Cary, NC
Click here to add this to my saved trials
356
mi
from 91732
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29412
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
2102
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
1853
mi
from 91732
Chattanooga, TN
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
2117
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
2032
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
804
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
2288
mi
from 91732
Columbia, MD
Click here to add this to my saved trials
2104
mi
from 91732
Columbia, SC
Click here to add this to my saved trials
1902
mi
from 91732
Columbus, GA
Click here to add this to my saved trials
1959
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
1293
mi
from 91732
Corpus Christi, TX
Click here to add this to my saved trials
1303
mi
from 91732
Council Bluffs, IA
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
1875
mi
from 91732
Crestview Hills, KY
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
2295
mi
from 91732
Danville, PA
Click here to add this to my saved trials
1960
mi
from 91732
Dearbon, MI
Click here to add this to my saved trials
?
mi
from 91732
DeLand, FL
Click here to add this to my saved trials
?
mi
from 91732
Delaware, OH
Click here to add this to my saved trials
2304
mi
from 91732
Delray Beach, FL
Click here to add this to my saved trials
817
mi
from 91732
Denver, CO
Click here to add this to my saved trials
1422
mi
from 91732
Des Moines, IA
Click here to add this to my saved trials
1899
mi
from 91732
Dothan, AL
Click here to add this to my saved trials
558
mi
from 91732
Draper, UT
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
2200
mi
from 91732
Duncansville, PA
Click here to add this to my saved trials
2202
mi
from 91732
Durham, NC
Click here to add this to my saved trials
1511
mi
from 91732
Edina, MN
Click here to add this to my saved trials
2413
mi
from 91732
Edison, NJ
Click here to add this to my saved trials
2422
mi
from 91732
Elizabeth, NJ
Click here to add this to my saved trials
Elizabeth City, North Carolina 27909
2345
mi
from 91732
Elizabeth City, NC
Click here to add this to my saved trials
2296
mi
from 91732
Elkridge, MD
Click here to add this to my saved trials
2376
mi
from 91732
Elmer, NJ
Click here to add this to my saved trials
1811
mi
from 91732
Elwood, IN
Click here to add this to my saved trials
2324
mi
from 91732
Endwell, NY
Click here to add this to my saved trials
2321
mi
from 91732
Ephrata, PA
Click here to add this to my saved trials
86
mi
from 91732
Escondido, CA
Click here to add this to my saved trials
1715
mi
from 91732
Evansville, IN
Click here to add this to my saved trials
Fall River, Massachusetts 02720
2576
mi
from 91732
Fall River, MA
Click here to add this to my saved trials
1276
mi
from 91732
Fremont, NE
Click here to add this to my saved trials
207
mi
from 91732
Fresno, CA
Click here to add this to my saved trials
2103
mi
from 91732
Gainesville, FL
Click here to add this to my saved trials
1600
mi
from 91732
Germantown, TN
Click here to add this to my saved trials
807
mi
from 91732
Golden, CO
Click here to add this to my saved trials
1174
mi
from 91732
Grand Island, NE
Click here to add this to my saved trials
1745
mi
from 91732
Green Bay, WI
Click here to add this to my saved trials
Greensboro, North Carolina 27401
2152
mi
from 91732
Greensboro, NC
Click here to add this to my saved trials
Greenville, North Carolina 27834
2290
mi
from 91732
Greenville, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
2019
mi
from 91732
Greenville, SC
Click here to add this to my saved trials
2029
mi
from 91732
Greer, SC
Click here to add this to my saved trials
1720
mi
from 91732
Gurnee, IL
Click here to add this to my saved trials
1733
mi
from 91732
Hammond, IN
Click here to add this to my saved trials
25
mi
from 91732
Harbor City, CA
Click here to add this to my saved trials
2576
mi
from 91732
Haverhill, MA
Click here to add this to my saved trials
218
mi
from 91732
Henderson, NV
Click here to add this to my saved trials
2069
mi
from 91732
Hickory, NC
Click here to add this to my saved trials
2033
mi
from 91732
Hodges, SC
Click here to add this to my saved trials
2573
mi
from 91732
Honolulu, HI
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92646
28
mi
from 91732
Huntington Beach, CA
Click here to add this to my saved trials
1201
mi
from 91732
Hurst, TX
Click here to add this to my saved trials
1609
mi
from 91732
Jackson, MS
Click here to add this to my saved trials
1653
mi
from 91732
Jackson, TN
Click here to add this to my saved trials
2127
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Jacksonville Beach, Florida 32250
2145
mi
from 91732
Jacksonville Beach, FL
Click here to add this to my saved trials
Jersey Shore, Pennsylvania 17740
2261
mi
from 91732
Jersey Shore, PA
Click here to add this to my saved trials
1840
mi
from 91732
Kalamazoo, MI
Click here to add this to my saved trials