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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


Phase 3
45 Years
N/A
Open (Enrolling)
Both
Obesity, Overweight

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time from treatment period randomization to the first confirmed occurrence of MACE

Outcome Time Frame:

Day 1 to first confirmed occurrence, assessed up to 4 years

Safety Issue:

Yes

Principal Investigator

Senior Vice President, Head of Global Development

Investigator Role:

Study Director

Investigator Affiliation:

Orexigen Therapeutics, Inc

Authority:

United States: Food and Drug Administration

Study ID:

NB-CVOT

NCT ID:

NCT01601704

Start Date:

June 2012

Completion Date:

July 2017

Related Keywords:

  • Obesity
  • Overweight
  • Body Weight
  • Bupropion
  • Cardiovascular Diseases
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Endocrine System Diseases
  • Glucose Metabolism Disorders
  • Heart Diseases
  • Metabolic Diseases
  • Narcotic Antagonists
  • Naltrexone
  • Nutrition Disorders
  • Obesity
  • Overnutrition
  • Overweight
  • Obesity
  • Overweight

Name

Location

Baylor College of Medicine Houston, Texas  77030
Medical University of South Carolina Charleston, South Carolina  29425-0721
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Boston Medical Center Boston, Massachusetts  02118
Geisinger Medical Group State College, Pennsylvania  16801
SUNY Upstate Medical University Syracuse, New York  13210
Advanced Clinical Concepts Temple, Pennsylvania  19560
Radiant Research Daytona Beach, Florida  32114
Blair Medical Associates Altoona, Pennsylvania  16601
The Cleveland Clinic Cleveland, Ohio  44195
McFarland Clinic Ames, Iowa  50010
Los Angeles Biomedical Research Institute Torrance, California  90502
Investigative Clinical Research of Indiana Indianapolis, Indiana  46254
Wake Research Associates Raleigh, North Carolina  27612
Advanced Clinical Research West Jordan, Utah  84088
Mercy Health Research St. Louis, Missouri  63141
Walla Walla Clinic Walla Walla, Washington  99362
Coastal Clinical Research Mobile, Alabama  36608
Radiant Research Greer, South Carolina  29651
Integrated Research Group Riverside, California  92501
Lynn Institute of the Rockies Colorado Springs, Colorado  80909
Radiant Research Salt Lake City, Utah  84107
Lyndhurst Gynecologic Associates Winston-Salem, North Carolina  27103
Radiant Research 7042 East Broadway Tucson, Arizona  85710
Radiant Research 1275 Oletangy River Rd, Suite 202, Columbus, Ohio  43212
Southwest Heart Tucson, Arizona  85710
Stamford Therapeutics Consortium Stamford, Connecticut  06905
Alfieri Cardiology Newark, Delaware  19713
Cardiology Consultants Pensacola, Florida  32501
Alexandria Cardiology Clinic Alexandria, Louisiana  71301
Olive Branch Family Medical Center Olive Branch, Mississippi  38654
Holston Medical Group Bristol, Tennessee  37620
North Dallas Research Associates Mckinney, Texas  75069
Research Institute of Dallas Dallas, Texas  75231
Sonterra Clinical Research San Antonio, Texas  78205
University Clinical Research - DeLand DeLand, Florida  32720
Clinical Research Atlanta Stockbridge, Georgia  30281
Northside Internal Medicine Spokane, Washington  99208
Infosphere Clinical Research West Hills, California  91307
Hope Research Institute Phoenix, Arizona  
Florida Research Network Gainesville, Florida  32605
PMI Health Research Group Atlanta, Georgia  30312
Centennial Medical Group Elkridge, Maryland  21075
Pennington Biomedical Research Center Baton Rouge, Louisiana  70808
Columbia Medical Practice Columbia, Maryland  21045
New West Physicians Golden, Colorado  80401
Kore Cv Research Jackson, Tennessee  38305
Rapid Medical Research Cleveland, Ohio  44122
DiscoveResearch Bryan, Texas  77802
Lynn Institute of the Ozarks Little Rock, Arkansas  72205
Investigator's Research Group Brownsburg, Indiana  
Southeast Regional Research Group Columbus, Georgia  31904
American Institute of Research Whittier, California  90603
Lynn Health Science Institute Oklahoma City, Oklahoma  73112
PMG Research of Charlotte Charlotte, North Carolina  28209
Meridien Research Bradenton, Florida  34208
Clinical Research of Central Florida Plant City, Florida  33563
Advanced Clinical Research Meridian, Idaho  83642
Coastal Carolina Research Center Mt. Pleasant, South Carolina  29464
Georgia Clinical Research Austell, Georgia  30106
HealthCare Partners Alhambra, California  91801
Suncoast Research Group Miami, Florida  33135
PMG Research of Wilmington Wilmington, North Carolina  28401
Maine Research Associates Auburn, Maine  04210
PMG Research of Charleston Mt. Pleasant, South Carolina  29464
Zasa Clinical Research Boyton Beach, Florida  33472
PMG Research of Winston-Salem Winston-Salem, North Carolina  27103
Health Concepts Rapid City, South Dakota  57702
Suncoast Clinical Research New Port Richey, Florida  34652
Clinical Trial Network Houston, Texas  77074
Radiant Research Birmingham, Alabama  35209
Birmingham Heart Clinic Birmingham, Alabama  35325
Central Alabama Research Birmingham, Alabama  35209
Digestive Health Specialists of the Southeast Dothan, Alabama  36305
Clinical Research Advantage Chandler, Arizona  85224
Elite Clinical Studies Phoenix, Arizona  85018
Quality of Life Medical & Research Center Tucson, Arizona  85712
Preferred Research Partners Little Rock, Arkansas  72205
Anaheim Clinical Trials Anaheim, California  92801
Med Investigators Carmichael, California  95608
AMCR Institute Escondido, California  92026
Valley Research Fresno, California  93720
Diabetes/Lipid Management and Research Center Huntington Beach, California  92648
Obesity Research Network Scripps Clinic La Jolla, California  92037
XiMED Center for Weight Management La Jolla, California  92037
Torrance Clinical Research Institute Lomita, California  90717
Bayview Research Group Paramount, California  90723
Northern CA Research Sacramento, California  95821
Radiant Research Santa Rosa, California  95405
Santa Rosa Cardiology Medical Group Santa Rosa, California  95405
Encompass Clinical Research Spring Valley, California  91978
Westlake Medical Research Westlake Village, California  91361
Pikes Peak Cardiology Colorado Springs, Colorado  80932
Clinical Research Advantage Colorado Springs, Colorado  80922
Radiant Research Denver, Colorado  80239
Lynn Institute of Denver Denver, Colorado  80246
Aurora Denver Cardiology Associates Denver, Colorado  80218
Soundview Research Medical Norwalk, Connecticut  06851
Cardiology Associates of Fairfield County Stamford, Connecticut  06905
Capital Medical Associates Washington, District of Columbia  20036
Innovative Research Clearwater, Florida  33756
DBC Research Deerfield Beach, Florida  33441
Cohen Medical Associates Delray Beach, Florida  33446
Edgewater Medical Research Edgewater, Florida  32132
Westside Center for Clinical Research Jacksonville, Florida  32205
Baptist Heart Specialists Jacksonville Beach, Florida  32250
Accelovance Melbourne, Florida  32935
Translational Research Institute for Metabolism and Diabetes Orlando, Florida  32804
South Broward Research Pembroke Pines, Florida  33027
Pines Clinical Research Pembroke Pines, Florida  33028
Indian River Medical Associates Vero Beach, Florida  32960
Cardiology Partners Clinical Research Institute Wellington, Florida  33449
Radiant Research Atlanta, Georgia  30342
PICR Clinic Atlanta, Georgia  30338
Physicians Research Associates Lawrenceville, Georgia  30046
Atlanta Ropheka Medical Center Riverdale, Georgia  30274
SERRG-Savannah Savannah, Georgia  31406
East-West Medical Research Institute Honolulu, Hawaii  96814
Solaris Clinical Research Meridian, Idaho  83646
Radiant Research Chicago, Illinois  60654
Apex Medical Research Chicago, Illinois  60616
Cedar Crosse Research Center Chicago, Illinois  60607
Clinical Investigation Specialists Gurnee, Illinois  60031
Consultants in Cardiovascular Medicine Melrose Park, Illinois  60160
Premier Healthcare Bloomington, Indiana  47403
MediSphere Medical Research Center Evansville, Indiana  47714
Cardiology Associates Hammond, Indiana  46320
Memorial Medical Group South Bend, Indiana  46601
Northwest Indiana Center for Clinical Research Valparaiso, Indiana  46383
Clinical Research Advantage Council Bluffs, Iowa  51503
Iowa Diabetes and Endocrinology Research Center Des Moines, Iowa  50314
Radiant Research Overland Park, Kansas  66202
Heartland Research Associates Wichita, Kansas  67207
St. Elizabeth Physicians Crestview Hills, Kentucky  41017
L-MARC Research Center Louisville, Kentucky  40213
Medical Office Mount Sterling, Kentucky  40353
Arthritis and Diabetes Clinic Monroe, Louisiana  71203
Natchitoches Internal Medicine Natchitoches, Louisiana  71457
Northeast Cardiology Associates Bangor, Maine  04401
Model Clinical Research Baltimore, Maryland  21204
Lutherville Personal Physicians Lutherville, Maryland  21093
Delmarva Heart Research Foundation Salisbury, Maryland  21804
BEACON Clinical Research Brockton, Massachusetts  02301
Genesis Clinical Research and Consulting Fall River, Massachusetts  02720
ActivMed Practices and Research Haverhill, Massachusetts  01830
Quest Research Institute Bingham Farms, Michigan  48025
Alzohaili Medical Consultants Dearborn, Michigan  48124
Westside Family Medical Center Kalamazoo, Michigan  49009
MCVI Research Midland, Michigan  48670
Michigan Cardiovascular Institute Saginaw, Michigan  48601
American Center for Clinical Trials Southfield, Michigan  48034
Southwestern Medical Clinic Stevensville, Michigan  49127
Radiant Research Edina, Minnesota  55435
Mayo Clinic Cancer Center - Rochester Rochester, Minnesota  55905
Phillips Medical Services Jackson, Mississippi  39209
Cardiology Associates Research Tupelo, Mississippi  38801
Radiant Research St. Louis, Missouri  63141
Sundance Clinical Research St. Louis, Missouri  63141
Private Practice St. Louis, Missouri  63110
Big Sky Clinical Research Butte, Montana  59701
Montana Medical Research Missoula, Montana  59808
Clinical Research Advantage Fremont, Nebraska  68025
Internal Medical Associates of Grand Island Grand Island, Nebraska  68803
Westroads Clinical Research - Omaha Omaha, Nebraska  68114
Creighton Cardiac Center Omaha, Nebraska  68131
Clinical Research Consortium Las Vegas, Nevada  89119
Palm Research Center Las Vegas, Nevada  89102
Clinical Research Advantage Las Vegas, Nevada  89128
Reno Clinical Trials Sparks, Nevada  89434
Wellness and Research Center Belvidere, New Jersey  07823
Anderson and Collins Clinical Research Edison, New Jersey  08817
Central Jersey Medical Research Center Elizabeth, New Jersey  07202
NJ Heart Linden, New Jersey  07036
Lovelace Scientific Resources Albuquerque, New Mexico  87108
Montefiore Medical Center - Greene Medical Arts Pavilion Bronx, New York  10467
Bronx Lebanon Hospital Center Bronx, New York  10457
Regional Clinical Research Endwell, New York  13760
North Shore Diabetes and Endocrine Associates New Hyde Park, New York  11042
Gotham Cardiovascular Research New York, New York  10001
University Physicians Group Staten Island, New York  10301
Buffalo Cardiology and Pulmonary Associates Williamsville, New York  14221
PMG Research of Cary Cary, North Carolina  27518
The Center for Nutrition and Preventative Medicine Charlotte, North Carolina  28277
UNC - Chapel Hill School of Medicine Durham, North Carolina  27713
UNC Diabetes Research at Eagle Physicians Durham, North Carolina  27713
Eastern Carolina Cardiovascular Elizabeth City, North Carolina  27909
Bland Clinic Greensboro, North Carolina  27401
UNC Diabetes Research Greensboro, North Carolina  27401
Physicians East Greenville, North Carolina  27834
PMG Research of Hickory Hickory, North Carolina  28602
Burke Primary Care Clinical Research Morganton, North Carolina  28655
PMG Research of Raleigh Raleigh, North Carolina  27609
WakeMed Faculty Physicians Raleigh Cardiology Raleigh, North Carolina  27610
PMG Research of Salisbury Salisbury, North Carolina  28144
Cleveland Clinic Beachwood FHC Beachwood, Ohio  44122
Sterling Research Group Cincinnati, Ohio  45219
The Lindner Center for Research & Education Cincinnati, Ohio  45219
Delaware Research Delaware, Ohio  43015
PriMed Clinical Research Kettering, Ohio  45429
Smith Clinic Research Marion, Ohio  43302
RAS Health Marion, Ohio  43302
Your Diabetes Endocrine Nutrition Group Mentor, Ohio  44060
Cleveland Clinic Willoughby Hills FHC Willoughby Hills, Ohio  44094
Sunstone Medical Research Medford, Oregon  97504
Columbia Research Group Portland, Oregon  97239
Genesis Clinical Research Bensalem, Pennsylvania  19020
Altoona Center for Clinical Research - ACCR Duncansville, Pennsylvania  16635
Lycoming Internal Medicine Jersey Shore, Pennsylvania  17740
Oyster Point Family Health Center Lancaster, Pennsylvania  17601
Heart Specialists of Lancaster County Lancaster, Pennsylvania  17602
Green and Seidner Family Practice Lansdale, Pennsylvania  19446
Pearl Clinical Research Norristown, Pennsylvania  19401
Fay West Family Practice Scottdale, Pennsylvania  15683
Grand View - Lehigh Valley Health Services Sellersville, Pennsylvania  18960
Geisinger Clinic Cardiovascular Center for Clinical Research Wilkes Barre, Pennsylvania  18711
Medical Research South Charleston, South Carolina  29407
Ellipsis Research Group Columbia, South Carolina  29204
Upstate Pharmaceutical Research Greenville, South Carolina  29615
Mountain View Clinical Research Greer, South Carolina  29651
Piedmont Health Group Hodges, South Carolina  29653
Palmetto Clinical Trials Services Laurens, South Carolina  29360
PMG Research of Bristol Bristol, Tennessee  37620
Chattanooga Medical Research Chattanooga, Tennessee  37404
Stern Cardiovascular Foundation Germantown, Tennessee  38138
PMG Research of Knoxville Knoxville, Tennessee  37912
Southwind Medical Specialists Memphis, Tennessee  38125
Premier Internal Medicine Memphis, Tennessee  38119
3rd Coast Research Associates Corpus Christi, Texas  78414
Padre Coast Medical Associates Corpus Christi, Texas  78404
Radiant Research - Dallas North Dallas, Texas  75231
Baylor University Medical Campus - Baylor Endocrine Center Dallas, Texas  75246
Advances in Health Houston, Texas  77030
The Heart Care Center of Northwest Houston Houston, Texas  77070
Protenium Clinical Research Hurst, Texas  76054
R/D Clinical Research Lake Jackson, Texas  77566
Radiant Research San Antonio, Texas  78229
NECRSA Schertz, Texas  78154
Northwest Houston Heart Center Tomball, Texas  77375
Hillcrest Family Health Center Waco, Texas  76710
Progressive Clinical Research Bountiful, Utah  84010
Physicians Research Options Draper, Utah  84020
Phase II Sexual Medicine and Menopause Salt Lake City, Utah  84117
Endocrine Research Specialists South Ogden, Utah  84405
Alexandria Clinical Research Alexandria, Virginia  22304
National Clinical Research Norfolk, Virginia  23502
National Clinical Research-Richmond Richmond, Virginia  23294
Selma Medical Associates Winchester, Virginia  22601
Seattle Women's: Health, Research, Gynecology Seattle, Washington  98105
Universal Research Group Tacoma, Washington  98405
Clinical Investigation Specialists Kenosha, Wisconsin  53142
Gemini Scientific Madison, Wisconsin  53719