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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 MedicineHouston, Texas  77030
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Boston Medical CenterBoston, Massachusetts  02118
Geisinger Medical GroupState College, Pennsylvania  16801
SUNY Upstate Medical UniversitySyracuse, New York  13210
Advanced Clinical ConceptsTemple, Pennsylvania  19560
Radiant ResearchDaytona Beach, Florida  32114
Blair Medical AssociatesAltoona, Pennsylvania  16601
The Cleveland ClinicCleveland, Ohio  44195
McFarland ClinicAmes, Iowa  50010
Los Angeles Biomedical Research InstituteTorrance, California  90502
Investigative Clinical Research of IndianaIndianapolis, Indiana  46254
Wake Research AssociatesRaleigh, North Carolina  27612
Advanced Clinical ResearchWest Jordan, Utah  84088
Mercy Health ResearchSt. Louis, Missouri  63141
Walla Walla ClinicWalla Walla, Washington  99362
Coastal Clinical ResearchMobile, Alabama  36608
Radiant ResearchGreer, South Carolina  29651
Integrated Research GroupRiverside, California  92501
Lynn Institute of the RockiesColorado Springs, Colorado  80909
Radiant ResearchSalt Lake City, Utah  84107
Lyndhurst Gynecologic AssociatesWinston-Salem, North Carolina  27103
Radiant Research7042 East Broadway Tucson, Arizona  85710
Radiant Research1275 Oletangy River Rd, Suite 202, Columbus, Ohio  43212
Southwest HeartTucson, Arizona  85710
Stamford Therapeutics ConsortiumStamford, Connecticut  06905
Alfieri CardiologyNewark, Delaware  19713
Cardiology ConsultantsPensacola, Florida  32501
Alexandria Cardiology ClinicAlexandria, Louisiana  71301
Olive Branch Family Medical CenterOlive Branch, Mississippi  38654
Holston Medical GroupBristol, Tennessee  37620
North Dallas Research AssociatesMckinney, Texas  75069
Research Institute of DallasDallas, Texas  75231
Sonterra Clinical ResearchSan Antonio, Texas  78205
University Clinical Research - DeLandDeLand, Florida  32720
Clinical Research AtlantaStockbridge, Georgia  30281
Northside Internal MedicineSpokane, Washington  99208
Infosphere Clinical ResearchWest Hills, California  91307
Hope Research InstitutePhoenix, Arizona  
Florida Research NetworkGainesville, Florida  32605
PMI Health Research GroupAtlanta, Georgia  30312
Centennial Medical GroupElkridge, Maryland  21075
Pennington Biomedical Research CenterBaton Rouge, Louisiana  70808
Columbia Medical PracticeColumbia, Maryland  21045
New West PhysiciansGolden, Colorado  80401
Kore Cv ResearchJackson, Tennessee  38305
Rapid Medical ResearchCleveland, Ohio  44122
DiscoveResearchBryan, Texas  77802
Lynn Institute of the OzarksLittle Rock, Arkansas  72205
Investigator's Research GroupBrownsburg, Indiana  
Southeast Regional Research GroupColumbus, Georgia  31904
American Institute of ResearchWhittier, California  90603
Lynn Health Science InstituteOklahoma City, Oklahoma  73112
PMG Research of CharlotteCharlotte, North Carolina  28209
Meridien ResearchBradenton, Florida  34208
Clinical Research of Central FloridaPlant City, Florida  33563
Advanced Clinical ResearchMeridian, Idaho  83642
Coastal Carolina Research CenterMt. Pleasant, South Carolina  29464
Georgia Clinical ResearchAustell, Georgia  30106
HealthCare PartnersAlhambra, California  91801
Suncoast Research GroupMiami, Florida  33135
PMG Research of WilmingtonWilmington, North Carolina  28401
Maine Research AssociatesAuburn, Maine  04210
PMG Research of CharlestonMt. Pleasant, South Carolina  29464
Zasa Clinical ResearchBoyton Beach, Florida  33472
PMG Research of Winston-SalemWinston-Salem, North Carolina  27103
Health ConceptsRapid City, South Dakota  57702
Suncoast Clinical ResearchNew Port Richey, Florida  34652
Clinical Trial NetworkHouston, Texas  77074
Radiant ResearchBirmingham, Alabama  35209
Birmingham Heart ClinicBirmingham, Alabama  35325
Central Alabama ResearchBirmingham, Alabama  35209
Digestive Health Specialists of the SoutheastDothan, Alabama  36305
Clinical Research AdvantageChandler, Arizona  85224
Elite Clinical StudiesPhoenix, Arizona  85018
Quality of Life Medical & Research CenterTucson, Arizona  85712
Preferred Research PartnersLittle Rock, Arkansas  72205
Anaheim Clinical TrialsAnaheim, California  92801
Med InvestigatorsCarmichael, California  95608
AMCR InstituteEscondido, California  92026
Valley ResearchFresno, California  93720
Diabetes/Lipid Management and Research CenterHuntington Beach, California  92648
Obesity Research Network Scripps ClinicLa Jolla, California  92037
XiMED Center for Weight ManagementLa Jolla, California  92037
Torrance Clinical Research InstituteLomita, California  90717
Bayview Research GroupParamount, California  90723
Northern CA ResearchSacramento, California  95821
Radiant ResearchSanta Rosa, California  95405
Santa Rosa Cardiology Medical GroupSanta Rosa, California  95405
Encompass Clinical ResearchSpring Valley, California  91978
Westlake Medical ResearchWestlake Village, California  91361
Pikes Peak CardiologyColorado Springs, Colorado  80932
Clinical Research AdvantageColorado Springs, Colorado  80922
Radiant ResearchDenver, Colorado  80239
Lynn Institute of DenverDenver, Colorado  80246
Aurora Denver Cardiology AssociatesDenver, Colorado  80218
Soundview Research MedicalNorwalk, Connecticut  06851
Cardiology Associates of Fairfield CountyStamford, Connecticut  06905
Capital Medical AssociatesWashington, District of Columbia  20036
Innovative ResearchClearwater, Florida  33756
DBC ResearchDeerfield Beach, Florida  33441
Cohen Medical AssociatesDelray Beach, Florida  33446
Edgewater Medical ResearchEdgewater, Florida  32132
Westside Center for Clinical ResearchJacksonville, Florida  32205
Baptist Heart SpecialistsJacksonville Beach, Florida  32250
AccelovanceMelbourne, Florida  32935
Translational Research Institute for Metabolism and DiabetesOrlando, Florida  32804
South Broward ResearchPembroke Pines, Florida  33027
Pines Clinical ResearchPembroke Pines, Florida  33028
Indian River Medical AssociatesVero Beach, Florida  32960
Cardiology Partners Clinical Research InstituteWellington, Florida  33449
Radiant ResearchAtlanta, Georgia  30342
PICR ClinicAtlanta, Georgia  30338
Physicians Research AssociatesLawrenceville, Georgia  30046
Atlanta Ropheka Medical CenterRiverdale, Georgia  30274
SERRG-SavannahSavannah, Georgia  31406
East-West Medical Research InstituteHonolulu, Hawaii  96814
Solaris Clinical ResearchMeridian, Idaho  83646
Radiant ResearchChicago, Illinois  60654
Apex Medical ResearchChicago, Illinois  60616
Cedar Crosse Research CenterChicago, Illinois  60607
Clinical Investigation SpecialistsGurnee, Illinois  60031
Consultants in Cardiovascular MedicineMelrose Park, Illinois  60160
Premier HealthcareBloomington, Indiana  47403
MediSphere Medical Research CenterEvansville, Indiana  47714
Cardiology AssociatesHammond, Indiana  46320
Memorial Medical GroupSouth Bend, Indiana  46601
Northwest Indiana Center for Clinical ResearchValparaiso, Indiana  46383
Clinical Research AdvantageCouncil Bluffs, Iowa  51503
Iowa Diabetes and Endocrinology Research CenterDes Moines, Iowa  50314
Radiant ResearchOverland Park, Kansas  66202
Heartland Research AssociatesWichita, Kansas  67207
St. Elizabeth PhysiciansCrestview Hills, Kentucky  41017
L-MARC Research CenterLouisville, Kentucky  40213
Medical OfficeMount Sterling, Kentucky  40353
Arthritis and Diabetes ClinicMonroe, Louisiana  71203
Natchitoches Internal MedicineNatchitoches, Louisiana  71457
Northeast Cardiology AssociatesBangor, Maine  04401
Model Clinical ResearchBaltimore, Maryland  21204
Lutherville Personal PhysiciansLutherville, Maryland  21093
Delmarva Heart Research FoundationSalisbury, Maryland  21804
BEACON Clinical ResearchBrockton, Massachusetts  02301
Genesis Clinical Research and ConsultingFall River, Massachusetts  02720
ActivMed Practices and ResearchHaverhill, Massachusetts  01830
Quest Research InstituteBingham Farms, Michigan  48025
Alzohaili Medical ConsultantsDearborn, Michigan  48124
Westside Family Medical CenterKalamazoo, Michigan  49009
MCVI ResearchMidland, Michigan  48670
Michigan Cardiovascular InstituteSaginaw, Michigan  48601
American Center for Clinical TrialsSouthfield, Michigan  48034
Southwestern Medical ClinicStevensville, Michigan  49127
Radiant ResearchEdina, Minnesota  55435
Mayo Clinic Cancer Center - RochesterRochester, Minnesota  55905
Phillips Medical ServicesJackson, Mississippi  39209
Cardiology Associates ResearchTupelo, Mississippi  38801
Radiant ResearchSt. Louis, Missouri  63141
Sundance Clinical ResearchSt. Louis, Missouri  63141
Private PracticeSt. Louis, Missouri  63110
Big Sky Clinical ResearchButte, Montana  59701
Montana Medical ResearchMissoula, Montana  59808
Clinical Research AdvantageFremont, Nebraska  68025
Internal Medical Associates of Grand IslandGrand Island, Nebraska  68803
Westroads Clinical Research - OmahaOmaha, Nebraska  68114
Creighton Cardiac CenterOmaha, Nebraska  68131
Clinical Research ConsortiumLas Vegas, Nevada  89119
Palm Research CenterLas Vegas, Nevada  89102
Clinical Research AdvantageLas Vegas, Nevada  89128
Reno Clinical TrialsSparks, Nevada  89434
Wellness and Research CenterBelvidere, New Jersey  07823
Anderson and Collins Clinical ResearchEdison, New Jersey  08817
Central Jersey Medical Research CenterElizabeth, New Jersey  07202
NJ HeartLinden, New Jersey  07036
Lovelace Scientific ResourcesAlbuquerque, New Mexico  87108
Montefiore Medical Center - Greene Medical Arts PavilionBronx, New York  10467
Bronx Lebanon Hospital CenterBronx, New York  10457
Regional Clinical ResearchEndwell, New York  13760
North Shore Diabetes and Endocrine AssociatesNew Hyde Park, New York  11042
Gotham Cardiovascular ResearchNew York, New York  10001
University Physicians GroupStaten Island, New York  10301
Buffalo Cardiology and Pulmonary AssociatesWilliamsville, New York  14221
PMG Research of CaryCary, North Carolina  27518
The Center for Nutrition and Preventative MedicineCharlotte, North Carolina  28277
UNC - Chapel Hill School of MedicineDurham, North Carolina  27713
UNC Diabetes Research at Eagle PhysiciansDurham, North Carolina  27713
Eastern Carolina CardiovascularElizabeth City, North Carolina  27909
Bland ClinicGreensboro, North Carolina  27401
UNC Diabetes ResearchGreensboro, North Carolina  27401
Physicians EastGreenville, North Carolina  27834
PMG Research of HickoryHickory, North Carolina  28602
Burke Primary Care Clinical ResearchMorganton, North Carolina  28655
PMG Research of RaleighRaleigh, North Carolina  27609
WakeMed Faculty Physicians Raleigh CardiologyRaleigh, North Carolina  27610
PMG Research of SalisburySalisbury, North Carolina  28144
Cleveland Clinic Beachwood FHCBeachwood, Ohio  44122
Sterling Research GroupCincinnati, Ohio  45219
The Lindner Center for Research & EducationCincinnati, Ohio  45219
Delaware ResearchDelaware, Ohio  43015
PriMed Clinical ResearchKettering, Ohio  45429
Smith Clinic ResearchMarion, Ohio  43302
RAS HealthMarion, Ohio  43302
Your Diabetes Endocrine Nutrition GroupMentor, Ohio  44060
Cleveland Clinic Willoughby Hills FHCWilloughby Hills, Ohio  44094
Sunstone Medical ResearchMedford, Oregon  97504
Columbia Research GroupPortland, Oregon  97239
Genesis Clinical ResearchBensalem, Pennsylvania  19020
Altoona Center for Clinical Research - ACCRDuncansville, Pennsylvania  16635
Lycoming Internal MedicineJersey Shore, Pennsylvania  17740
Oyster Point Family Health CenterLancaster, Pennsylvania  17601
Heart Specialists of Lancaster CountyLancaster, Pennsylvania  17602
Green and Seidner Family PracticeLansdale, Pennsylvania  19446
Pearl Clinical ResearchNorristown, Pennsylvania  19401
Fay West Family PracticeScottdale, Pennsylvania  15683
Grand View - Lehigh Valley Health ServicesSellersville, Pennsylvania  18960
Geisinger Clinic Cardiovascular Center for Clinical ResearchWilkes Barre, Pennsylvania  18711
Medical Research SouthCharleston, South Carolina  29407
Ellipsis Research GroupColumbia, South Carolina  29204
Upstate Pharmaceutical ResearchGreenville, South Carolina  29615
Mountain View Clinical ResearchGreer, South Carolina  29651
Piedmont Health GroupHodges, South Carolina  29653
Palmetto Clinical Trials ServicesLaurens, South Carolina  29360
PMG Research of BristolBristol, Tennessee  37620
Chattanooga Medical ResearchChattanooga, Tennessee  37404
Stern Cardiovascular FoundationGermantown, Tennessee  38138
PMG Research of KnoxvilleKnoxville, Tennessee  37912
Southwind Medical SpecialistsMemphis, Tennessee  38125
Premier Internal MedicineMemphis, Tennessee  38119
3rd Coast Research AssociatesCorpus Christi, Texas  78414
Padre Coast Medical AssociatesCorpus Christi, Texas  78404
Radiant Research - Dallas NorthDallas, Texas  75231
Baylor University Medical Campus - Baylor Endocrine CenterDallas, Texas  75246
Advances in HealthHouston, Texas  77030
The Heart Care Center of Northwest HoustonHouston, Texas  77070
Protenium Clinical ResearchHurst, Texas  76054
R/D Clinical ResearchLake Jackson, Texas  77566
Radiant ResearchSan Antonio, Texas  78229
NECRSASchertz, Texas  78154
Northwest Houston Heart CenterTomball, Texas  77375
Hillcrest Family Health CenterWaco, Texas  76710
Progressive Clinical ResearchBountiful, Utah  84010
Physicians Research OptionsDraper, Utah  84020
Phase II Sexual Medicine and MenopauseSalt Lake City, Utah  84117
Endocrine Research SpecialistsSouth Ogden, Utah  84405
Alexandria Clinical ResearchAlexandria, Virginia  22304
National Clinical ResearchNorfolk, Virginia  23502
National Clinical Research-RichmondRichmond, Virginia  23294
Selma Medical AssociatesWinchester, Virginia  22601
Seattle Women's: Health, Research, GynecologySeattle, Washington  98105
Universal Research GroupTacoma, Washington  98405
Clinical Investigation SpecialistsKenosha, Wisconsin  53142
Gemini ScientificMadison, Wisconsin  53719