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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01601704
First received: May 14, 2012
Last updated: May 20, 2014
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Obesity
Overweight
Drug: NB32
Drug: PBO
Behavioral: Weight Management Program
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • Time from treatment period randomization to the first confirmed occurrence of MACE [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time from treatment period randomization to the first confirmed occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or nonfatal unstable angina requiring hospitalization [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ] [ Designated as safety issue: Yes ]
  • Time from treatment period randomization to the confirmed occurrence of cardiovascular death (including fatal myocardial infarction, fatal stroke) [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ] [ Designated as safety issue: Yes ]
  • Time from treatment period randomization to the first confirmed occurrence of myocardial infarction (nonfatal or fatal) [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ] [ Designated as safety issue: Yes ]
  • Time from treatment period randomization to the first confirmed occurrence of stroke (nonfatal or fatal) [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10400
Study Start Date: June 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NB32 Drug: NB32
Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Other Name: CONTRAVE
Behavioral: Weight Management Program
A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
Other Name: WeightMate (Tm)
Placebo Comparator: PBO Drug: PBO
Placebo. Administered in addition to the weight management program.
Behavioral: Weight Management Program
A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
Other Name: WeightMate (Tm)

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601704

  Hide Study Locations
Locations
United States, Alabama
Radiant Research
Birmingham, Alabama, United States, 35209
Birmingham Heart Clinic
Birmingham, Alabama, United States, 35325
Central Alabama Research
Birmingham, Alabama, United States, 35209
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States, 36305
Coastal Clinical Research
Mobile, Alabama, United States, 36608
United States, Arizona
Radiant Research
Chandler, Arizona, United States, 85224
Clinical Research Advantage
Chandler, Arizona, United States, 85224
Clinical Research Advantage
Mesa, Arizona, United States, 85213
Elite Clinical Studies
Phoenix, Arizona, United States, 85018
HOPE Research Institute
Phoenix, Arizona, United States, 85050
Clinical Research Advantage
Phoenix, Arizona, United States, 85020
Radiant Research
Scottsdale, Arizona, United States, 85251
Radiant Research
Tucson, Arizona, United States, 85710
Southwest Heart
Tucson, Arizona, United States, 85710
Quality of Life Medical & Research Center
Tucson, Arizona, United States, 85712
United States, Arkansas
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72205
Preferred Research Partners
Little Rock, Arkansas, United States, 72205
United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Med Investigators
Carmichael, California, United States, 95608
AMCR Institute
Escondido, California, United States, 92026
Valley Research
Fresno, California, United States, 93720
Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States, 92648
Obesity Research Network Scripps Clinic
La Jolla, California, United States, 92037
XiMED Center for Weight Management
La Jolla, California, United States, 92037
Torrance Clinical Research Institute
Lomita, California, United States, 90717
American Institute of Research
Los Angeles, California, United States, 90017
Bayview Research Group
Paramount, California, United States, 90723
HealthCare Partners
Pasadena, California, United States, 91105
Integrated Research Group
Riverside, California, United States, 92506
Northern CA Research
Sacramento, California, United States, 95821
Radiant Research
Santa Rosa, California, United States, 95405
Santa Rosa Cardiology Medical Group
Santa Rosa, California, United States, 95405
Encompass Clinical Research
Spring Valley, California, United States, 91978
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
Westlake Medical Research
Westlake Village, California, United States, 91361
United States, Colorado
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States, 80907
Pikes Peak Cardiology
Colorado Springs, Colorado, United States, 80932
Clinical Research Advantage
Colorado Springs, Colorado, United States, 80922
Clinical Research Advantage
Colorado Springs, Colorado, United States, 80906
Radiant Research
Denver, Colorado, United States, 80239
Lynn Institute of Denver
Denver, Colorado, United States, 80246
Aurora Denver Cardiology Associates
Denver, Colorado, United States, 80218
New West Physicians
Golden, Colorado, United States, 80401
United States, Connecticut
Soundview Research Medical
Norwalk, Connecticut, United States, 06851
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
Cardiology Associates of Fairfield County
Stamford, Connecticut, United States, 06905
United States, Delaware
Alfieri Cardiology
Newark, Delaware, United States, 19713
United States, District of Columbia
Capital Medical Associates
Washington, District of Columbia, United States, 20036
United States, Florida
Zasa Clinical Research
Boynton Beach, Florida, United States, 33472
Meridien Research
Brooksville, Florida, United States, 34601
Innovative Research
Clearwater, Florida, United States, 33756
DBC Research
Deerfield Beach, Florida, United States, 33441
University Clinical Research - Deland
Deland, Florida, United States, 32720
Cohen Medical Associates
Delray Beach, Florida, United States, 33446
Edgewater Medical Research
Edgewater, Florida, United States, 32132
Florida Research Network
Gainesville, Florida, United States, 32605
Westside Center for Clinical Research
Jacksonville, Florida, United States, 32205
Baptist Heart Specialists
Jacksonville Beach, Florida, United States, 32250
Accelovance
Melbourne, Florida, United States, 32935
Suncoast Research Group
Miami, Florida, United States, 33135
Suncoast Clinical Research
New Port Richey, Florida, United States, 34652
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804
Suncoast Clinical Research
Palm Harbor, Florida, United States, 34684
South Broward Research
Pembroke Pines, Florida, United States, 33027
Pines Clinical Research
Pembroke Pines, Florida, United States, 33028
Cardiology Consultants
Pensacola, Florida, United States, 32503
Radiant Research
Pinellas Park, Florida, United States, 33781
Meridien Research
St. Petersburg, Florida, United States, 33709
Indian River Medical Associates
Vero Beach, Florida, United States, 32960
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States, 33449
Clinical Research of Central Florida
Winter Haven, Florida, United States, 33880
United States, Georgia
Radiant Research
Atlanta, Georgia, United States, 30342
PMI Health Research Group
Atlanta, Georgia, United States, 30312
PICR Clinic
Atlanta, Georgia, United States, 30338
Georgia Clinical Research
Austell, Georgia, United States, 30106
Southeast Regional Research Group
Columbus, Georgia, United States, 31904
Physicians Research Associates
Lawrenceville, Georgia, United States, 30046
Atlanta Ropheka Medical Center
Riverdale, Georgia, United States, 30274
SERRG-Savannah
Savannah, Georgia, United States, 31406
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Idaho
Advanced Clinical Research
Boise, Idaho, United States, 83642
Solaris Clinical Research
Meridian, Idaho, United States, 83646
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60654
Apex Medical Research
Chicago, Illinois, United States, 60616
Cedar Crosse Research Center
Chicago, Illinois, United States, 60607
Clinical Investigation Specialists
Gurnee, Illinois, United States, 60031
Consultants in Cardiovascular Medicine
Melrose Park, Illinois, United States, 60160
United States, Indiana
Premier Healthcare
Bloomington, Indiana, United States, 47403
Investigator's Research Group
Brownsburg, Indiana, United States, 46112
Investigative Clinical Research of Indiana
Elwood, Indiana, United States, 46036
MediSphere Medical Research Center
Evansville, Indiana, United States, 47714
Cardiology Associates
Hammond, Indiana, United States, 46320
Memorial Medical Group
South Bend, Indiana, United States, 46601
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, United States, 46383
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
Clinical Research Advantage
Council Bluffs, Iowa, United States, 51503
Iowa Diabetes and Endocrinology Research Center
Des Moines, Iowa, United States, 50314
United States, Kansas
Radiant Research
Overland Park, Kansas, United States, 66202
Heartland Research Associates
Wichita, Kansas, United States, 67207
Heartland Research Associates
Wichita, Kansas, United States, 67205
United States, Kentucky
St. Elizabeth Physicians
Crestview Hills, Kentucky, United States, 41017
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Louisiana
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States, 71301
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Arthritis and Diabetes Clinic
Monroe, Louisiana, United States, 71203
Natchitoches Internal Medicine
Natchitoches, Louisiana, United States, 71457
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
Northeast Cardiology Associates
Bangor, Maine, United States, 04401
United States, Maryland
Model Clinical Research
Baltimore, Maryland, United States, 21204
Columbia Medical Practice
Columbia, Maryland, United States, 21045
Centennial Medical Group
Elkridge, Maryland, United States, 21075
Lutherville Personal Physicians
Lutherville, Maryland, United States, 21093
Delmarva Heart Research Foundation
Salisbury, Maryland, United States, 21804
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
BEACON Clinical Research
Brockton, Massachusetts, United States, 02301
Genesis Clinical Research and Consulting
Fall River, Massachusetts, United States, 02720
ActivMed Practices and Research
Haverhill, Massachusetts, United States, 01830
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
Alzohaili Medical Consultants
Dearborn, Michigan, United States, 48124
Westside Family Medical Center
Kalamazoo, Michigan, United States, 49009
MCVI Research
Midland, Michigan, United States, 48670
Michigan Cardiovascular Institute
Saginaw, Michigan, United States, 48601
American Center for Clinical Trials
Southfield, Michigan, United States, 48034
Southwestern Medical Clinic
Stevensville, Michigan, United States, 49127
United States, Minnesota
Radiant Research
Edina, Minnesota, United States, 55435
Mayo Clinic Cancer Center - Rochester
Rochester, Minnesota, United States, 55905
United States, Mississippi
Phillips Medical Services
Jackson, Mississippi, United States, 39209
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States, 38654
Cardiology Associates Research
Tupelo, Mississippi, United States, 38801
United States, Missouri
Radiant Research
St. Louis, Missouri, United States, 63141
Mercy Health Research
St. Louis, Missouri, United States, 63141
Sundance Clinical Research
St. Louis, Missouri, United States, 63141
Private Practice
St. Louis, Missouri, United States, 63110
United States, Montana
Big Sky Clinical Research
Butte, Montana, United States, 59701
Montana Medical Research
Missoula, Montana, United States, 59808
United States, Nebraska
Clinical Research Advantage
Fremont, Nebraska, United States, 68025
Internal Medical Associates of Grand Island
Grand Island, Nebraska, United States, 68803
Clinical Research Advantage
Omaha, Nebraska, United States, 68130
Westroads Clinical Research - Omaha
Omaha, Nebraska, United States, 68114
Creighton Cardiac Center
Omaha, Nebraska, United States, 68131
United States, Nevada
Clinical Research Consortium
Las Vegas, Nevada, United States, 89119
Palm Research Center
Las Vegas, Nevada, United States, 89102
Clinical Research Advantage
Las Vegas, Nevada, United States, 89128
Clinical Research Advantage
Las Vegas, Nevada, United States, 89183
United States, New Jersey
Wellness and Research Center
Belvidere, New Jersey, United States, 07823
Central Jersey Medical Research Center
Elizabeth, New Jersey, United States, 07202
NJ Heart
Linden, New Jersey, United States, 07036
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Montefiore Medical Center - Greene Medical Arts Pavilion
Bronx, New York, United States, 10467
Bronx Lebanon Hospital Center
Bronx, New York, United States, 10457
Regional Clinical Research
Endwell, New York, United States, 13760
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, United States, 11042
Gotham Cardiovascular Research
New York, New York, United States, 10001
University Physicians Group
Staten Island, New York, United States, 10301
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Buffalo Cardiology and Pulmonary Associates
Williamsville, New York, United States, 14221
United States, North Carolina
PMG Research of Cary
Cary, North Carolina, United States, 27518
PMG Research of Charlotte
Charlotte, North Carolina, United States, 28209
UNC - Chapel Hill School of Medicine
Durham, North Carolina, United States, 27713
UNC Diabetes Research at Eagle Physicians
Durham, North Carolina, United States, 27713
Eastern Carolina Cardiovascular
Elizabeth City, North Carolina, United States, 27909
Bland Clinic
Greensboro, North Carolina, United States, 27401
UNC Diabetes Research
Greensboro, North Carolina, United States, 27401
Physicians East
Greenville, North Carolina, United States, 27834
PMG Research of Hickory
Hickory, North Carolina, United States, 28602
Burke Primary Care Clinical Research
Morganton, North Carolina, United States, 28655
Wake Research Associates
Raleigh, North Carolina, United States, 27612
PMG Research of Raleigh
Raleigh, North Carolina, United States, 27609
PMG Research of Salisbury
Salisbury, North Carolina, United States, 28144
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
Lyndhurst Gynecologic Associates
Winston Salem, North Carolina, United States, 27103
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Radiant Research
Akron, Ohio, United States, 44311
Cleveland Clinic Beachwood FHC
Beachwood, Ohio, United States, 44122
Radiant Research
Cincinnati, Ohio, United States, 45249
Sterling Research Group
Cincinnati, Ohio, United States, 45219
The Lindner Center for Research & Education
Cincinnati, Ohio, United States, 45219
Rapid Medical Research
Cleveland, Ohio, United States, 44122
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Radiant Research
Columbus, Ohio, United States, 43212
Delaware Research
Delaware, Ohio, United States, 43015
PriMed Clinical Research
Kettering, Ohio, United States, 45429
Smith Clinic Research
Marion, Ohio, United States, 43302
RAS Health
Marion, Ohio, United States, 43302
Your Diabetes Endocrine Nutrition Group
Mentor, Ohio, United States, 44060
Cleveland Clinic Willoughby Hills FHC
Willoughby Hills, Ohio, United States, 44094
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Sunstone Medical Research
Medford, Oregon, United States, 97504
Columbia Research Group
Portland, Oregon, United States, 97239
United States, Pennsylvania
Blair Medical Associates
Altoona, Pennsylvania, United States, 16602
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Altoona Center for Clinical Research - ACCR
Duncansville, Pennsylvania, United States, 16635
Lycoming Internal Medicine
Jersey Shore, Pennsylvania, United States, 17740
Oyster Point Family Health Center
Lancaster, Pennsylvania, United States, 17601
Heart Specialists of Lancaster County
Lancaster, Pennsylvania, United States, 17602
Green and Seidner Family Practice
Lansdale, Pennsylvania, United States, 19446
Pearl Clinical Research
Norristown, Pennsylvania, United States, 19401
Fay West Family Practice
Scottdale, Pennsylvania, United States, 15683
Grand View - Lehigh Valley Health Services
Sellersville, Pennsylvania, United States, 18960
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Advanced Clinical Concepts
West Reading, Pennsylvania, United States, 19611
Geisinger Clinic Cardiovascular Center for Clinical Research
Wilkes Barre, Pennsylvania, United States, 18711
United States, South Carolina
Radiant Research
Anderson, South Carolina, United States, 29621
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Medical Research South
Charleston, South Carolina, United States, 29407
Ellipsis Research Group
Columbia, South Carolina, United States, 29204
Upstate Pharmaceutical Research
Greenville, South Carolina, United States, 29615
Mountain View Clinical Research
Greer, South Carolina, United States, 29651
Radiant Research
Greer, South Carolina, United States, 29651
Piedmont Health Group
Hodges, South Carolina, United States, 29653
Palmetto Clinical Trials Services
Laurens, South Carolina, United States, 29360
PMG Research of Charleston
Mount Pleasant, South Carolina, United States, 29464
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
United States, South Dakota
Health Concepts
Rapid City, South Dakota, United States, 57702
United States, Tennessee
PMG Research of Bristol
Bristol, Tennessee, United States, 37620
Chattanooga Medical Research
Chattanooga, Tennessee, United States, 37404
Stern Cardiovascular Foundation
Germantown, Tennessee, United States, 38138
Kore CV Research
Jackson, Tennessee, United States, 38305
Holston Medical Group
Kingsport, Tennessee, United States, 37660
PMG Research of Knoxville
Knoxville, Tennessee, United States, 37912
Southwind Medical Specialists
Memphis, Tennessee, United States, 38125
United States, Texas
DiscoveResearch
Beaumont, Texas, United States, 77701
3rd Coast Research Associates
Corpus Christi, Texas, United States, 78414
Padre Coast Medical Associates
Corpus Christi, Texas, United States, 78404
Research Institute of Dallas
Dallas, Texas, United States, 75231
Radiant Research - Dallas North
Dallas, Texas, United States, 75231
Baylor University Medical Campus - Baylor Endocrine Center
Dallas, Texas, United States, 75246
The Heart Care Center of Northwest Houston
Houston, Texas, United States, 77070
Clinical Trial Network
Houston, Texas, United States, 77074
Advances in Health
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
Protenium Clinical Research
Hurst, Texas, United States, 76054
R/D Clinical Research
Lake Jackson, Texas, United States, 77566
North Dallas Research Associates
McKinney, Texas, United States, 75069
Radiant Research
San Antonio, Texas, United States, 78229
Sonterra Clinical Research
San Antonio, Texas, United States, 78240
NECRSA
Schertz, Texas, United States, 78154
Northwest Houston Heart Center
Tomball, Texas, United States, 77375
Hillcrest Family Health Center
Waco, Texas, United States, 76710
United States, Utah
Progressive Clinical Research
Bountiful, Utah, United States, 84010
Physicians Research Options
Draper, Utah, United States, 84020
Radiant Research
Murray, Utah, United States, 84123
Endocrine Research Specialists
South Ogden, Utah, United States, 84405
Advanced Clinical Research
West Jordan, Utah, United States, 84088
United States, Virginia
Alexandria Clinical Research
Alexandria, Virginia, United States, 22304
National Clinical Research
Norfolk, Virginia, United States, 23502
National Clinical Research-Richmond
Richmond, Virginia, United States, 23294
Selma Medical Associates
Winchester, Virginia, United States, 22601
United States, Washington
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States, 98105
Northside Internal Medicine
Spokane, Washington, United States, 99208
Universal Research Group
Tacoma, Washington, United States, 98405
Walla Walla Clinic
Walla Walla, Washington, United States, 99362
United States, Wisconsin
Clinical Investigation Specialists
Kenosha, Wisconsin, United States, 53142
Gemini Scientific
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
Study Director: Senior Vice President, Head of Global Development Orexigen Therapeutics, Inc
  More Information

No publications provided

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT01601704     History of Changes
Other Study ID Numbers: NB-CVOT, The Light Study
Study First Received: May 14, 2012
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:
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

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Naltrexone
Narcotic Antagonists
Bupropion
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014