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A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors (CAMELLIA-TIMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02019264
Recruitment Status : Active, not recruiting
First Posted : December 24, 2013
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Thrombolysis In Myocardial Infarction (TIMI) Academic Research Organization
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with CV disease and/or multiple CV risk factors.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease High Cardiovascular Risk Obesity Overweight Type 2 Diabetes Drug: APD356-Lorcaserin hydrochloride Drug: Placebo Phase 4

Detailed Description:
Approximately 12,000 subjects will be randomized to two treatment groups in a ratio of 1:1, stratified by the presence of established CV disease (approximately 80%) or CV risk factors without established CV disease (approximately 20%). Subjects will receive lorcaserin HCl 10 mg BID or placebo BID. The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization Phase will last up to 30 days and consist of one visit during which subjects will be screened for eligibility. The Randomization Phase will consist of two periods: Treatment and Follow-up. The Treatment Period will last for approximately 5 years with approximately 18 visits and Follow-up period is 30 (+ or - 10 days) from the end of treatment visit.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
Actual Study Start Date : January 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: APD356 10 mg
APD356 10 mg twice daily
Drug: APD356-Lorcaserin hydrochloride
APD356 10 mg twice daily

Placebo Comparator: Placebo
Placebo twice daily
Drug: Placebo
Placebo twice daily




Primary Outcome Measures :
  1. Time from randomization to first occurrence of Major Adverse Cardiovascular Events (MACE) [ Time Frame: Up to 5 years ]
    MACE events include: myocardial infarction, stroke and cardiovascular (CV) death

  2. Time from randomization to conversion to type 2 diabetes mellitus (T2DM) for subjects without any type of diabetes at Baseline [ Time Frame: Baseline, and specified timepoints up to 5 years ]
  3. Time from randomization to first occurrence of MACE+ [ Time Frame: Up to 5 years ]
    MACE+ events include: myocardial infarction, stroke, CV death, and hospitalization due to unstable angina, heart failure, or any coronary revascularization


Secondary Outcome Measures :
  1. Time from randomization to event of each component of MACE+ [ Time Frame: Up to 5 years ]
  2. Time from randomization to event of all-cause mortality [ Time Frame: Up to 5 years ]
  3. Time from randomization to event of new onset renal impairment or worsening existing renal impairment in subjects with T2DM at Baseline [ Time Frame: Up to 5 years ]
    New onset renal impairment or worsening existing renal impairment include the first occurrence of microalbuminuria, macroalbuminuria, worsening of albuminuria, newly developed CKD, or worsening of CKD, doubling of serum creatinine, or any of the following: ESRD, renal transplant, and renal death.

  4. Time from randomization to event of improvement in renal function [ Time Frame: Up to 5 years ]
  5. Change from Baseline in HbA[1c] at 6 months in subjects with T2DM at Baseline [ Time Frame: Baseline and 6 months ]
  6. The proportion of subjects who meet FDA-defined valvulopathy in echocardiographically determined heart valve changes [ Time Frame: Baseline and 1 year ]
    Comparison between lorcaserin HCl and placebo will be made at 1 year.

  7. The percent change from Baseline in echocardiographically-determined pulmonary arterial systolic pressure [ Time Frame: Baseline and 1 year ]
    Comparison between lorcaserin HCl and placebo will be made at 1 year.

  8. Time to conversion to normal glucose homeostasis [ Time Frame: Baseline and 1 year ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. BMI greater than or equal to 27 kg/m^2
  2. Subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program
  3. Age greater than or equal to 40 years with established CV disease as defined by one of the following:

    1. History of documented MI or ischemic stroke
    2. History of peripheral artery disease
    3. History of revascularization (coronary, carotid, or peripheral artery)
    4. Significant unrevascularized coronary arterial stenosis

OR

Age greater than or equal to 55 years for women or greater than or equal to 50 years for men who have T2DM without established CV disease plus at least one of the following CV risk factors:

  1. Hypertension, or currently receiving therapy for documented hypertension
  2. Dyslipidemia, or currently taking prescription lipid-lowering therapy for documented dyslipidemia
  3. Calculated creatinine clearance greater than or equal to 30 to less than or equal to 60 mL/min per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
  4. High hsCRP
  5. Urinary albumin-to-creatinine ratio (ACR) greater than or equal to 30 ug/mg

Subjects with T2DM may have a pre-existing or new diagnosis of T2DM. A new diagnosis of T2DM (ie, discovered at Screening) should be based on the 2013 American Diabetes Association (ADA) guidelines.

All T2DM subjects must have an HbA[1c] less than 10% at Screening. If subjects are being treated, or upon diagnosis need to be treated with antidiabetic agents, the T2DM treatment regimen must be stable for at least 3 months prior to randomization.

Exclusion Criteria

  1. Moderate or greater symptoms of congestive cardiac failure (New York Heart Association [NYHA] class III or IV)
  2. Known left ventricular (LV) ejection fraction less than 20%
  3. Moderate or greater symptoms of pulmonary hypertension (PH)
  4. Known severe valvular disease Moderate renal impairment, severe renal impairment, or end stage renal disease (ESRD) (calculated creatinine clearance less than 30 mL/min per the CKD-EPI equation based on ideal body weight)
  5. Severe hepatic impairment
  6. Use of other products intended for weight loss including prescription drugs, over-the-counter (OTC) drugs, and herbal preparations
  7. Use of more than one other serotonergic drug
  8. Use of drugs known to increase the risk for cardiac valvulopathy prior to Screening including, but not limited to: cyproheptadine, amoxapine, TCAs, mirtazapine, pergolide, ergotamine, methysergide, cabergoline
  9. History or evidence of clinically significant disease (e.g., malignancy, cardiac, respiratory, gastrointestinal, renal or psychiatric disease)
  10. Use of lorcaserin HCl prior to Screening or hypersensitivity to lorcaserin HCl or any of the excipients
  11. Planned bariatric surgery
  12. Females must not be breastfeeding or pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019264


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Locations
United States, Alabama
Advanced Cardiovascular, LLC
Alexander City, Alabama, United States, 35010
North Alabama Research Center, LLC
Athens, Alabama, United States, 35611
UAB Medical Center
Birmingham, Alabama, United States, 35294
Coastal Clinic Research, Inc.
Mobile, Alabama, United States, 36608
Mobile Heart Specialists, PC
Mobile, Alabama, United States, 36608
United States, Alaska
Alaska Heart Institute
Anchorage, Alaska, United States, 99508
United States, Arizona
Connect Clinical Research Center, LCC
Chandler, Arizona, United States, 85224
Arrowhead Health Centers
Glendale, Arizona, United States, 85306
Phoenix Heart, PLLC
Glendale, Arizona, United States, 85306
Eclipse Clinical Research
Tucson, Arizona, United States, 85745
United States, Arkansas
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
Arkansas Cardiology Clinic
Little Rock, Arkansas, United States, 72205
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
Preferred Research Partners
Little Rock, Arkansas, United States, 72211
United States, California
Clinical Research Alliance
Alhambra, California, United States, 91801
Central Cardiology
Bakersfield, California, United States, 93308
Cardiovascular Research Foundation of Southern Cal
Beverly Hills, California, United States, 90210
Capitol Interventional Cardiology
Carmichael, California, United States, 95608
San Diego Coastal Endocrinology Group AMC
Chula Vista, California, United States, 91911-3813
John Muir Physician Network Clinical Research Cent
Concord, California, United States, 94520
Medical Group of Encino
Encino, California, United States, 91436
Marin Endocrine Care and Research, Inc.
Greenbrae, California, United States, 94904
California Heart Specialists
Huntington Beach, California, United States, 92648
Del Rosario Medical Clinic, Inc.
Huntington Park, California, United States, 90255
Diabetes and Endocrine Associates
La Mesa, California, United States, 91942
La Mesa Cardiac Center
La Mesa, California, United States, 91942
Alliance Research Centers
Laguna Hills, California, United States, 92653
Torrance Clinical Research Institute, Inc.
Lomita, California, United States, 90717
Long Beach Center for Clinical Research
Long Beach, California, United States, 90807
Metabolic Clinic and Research Center
Los Angeles, California, United States, 90033
Beverly Hills Cardiology
Los Angeles, California, United States, 90067
VA Greater Los Angeles Health Care System
Los Angeles, California, United States, 90073
Clinical Interventions Research Institute
Mission Viejo, California, United States, 92692
Brigid Freyne MD Inc
Murrieta, California, United States, 92563
Valley Clinical Trials Inc
Northridge, California, United States, 91325
Carr Cardiology
Oceanside, California, United States, 92056
Northern California Clinical Research Center
Redding, California, United States, 96001
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, United States, 92101
University of California San Diego
San Diego, California, United States, 92103-8765
Ritchken and First MD's
San Diego, California, United States, 92117
West Coast Research, LLC
San Ramon, California, United States, 94582
Coastal Multi-Specialty Research
Santa Ana, California, United States, 92704
Westlake Medical Research
Thousand Oaks, California, United States, 91360
Harbor - UCLA Medical Center
Torrance, California, United States, 90509
Ronald Chochinov, MD
Ventura, California, United States, 93003
Ventura Cardiology Consultants Medical Group
Ventura, California, United States, 93003
Infosphere Clinical Research
West Hills, California, United States, 91307
United States, Colorado
UCH-MHS Cardiac Research
Colorado Springs, Colorado, United States, 80909
Creekside Endocrine Associates PC
Denver, Colorado, United States, 80209
New West Physicians, PC
Golden, Colorado, United States, 80401
University of Colorado Health
Loveland, Colorado, United States, 80538
United States, Connecticut
Connecticut Clinical Research, LLC
Bridgeport, Connecticut, United States, 06606
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Clinical Research Works, Bristol
Bristol, Connecticut, United States, 06010
Cardiology Associates of Fairfield County, Norwalk
Norwalk, Connecticut, United States, 06851
Cardiology Associates of Fairfield County, P.C.
Norwalk, Connecticut, United States, 06851
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
Connecticut Heart and Vascular Center
Trumbull, Connecticut, United States, 06611
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Delaware
Red Clay Research
Newark, Delaware, United States, 19713
Alfieri Cardiology
Wilmington, Delaware, United States, 19803-3733
United States, Florida
Aventura Heart Center
Aventura, Florida, United States, 33180
Zasa Clinical Research
Boynton Beach, Florida, United States, 33427
Meridien Research
Bradenton, Florida, United States, 34201
NOVA Southeastern University
Bradenton, Florida, United States, 34209
Bay Area Cardiology
Brandon, Florida, United States, 33511
Meridien Research, Brooksville
Brooksville, Florida, United States, 34601
Clearwater Cardiovascular and Interventional Cons.
Clearwater, Florida, United States, 33756
Clinical Research of South Florida
Coral Gables, Florida, United States, 33143
Holy Cross Medical Group
Coral Springs, Florida, United States, 33065
Cardiology Research Associates
Daytona Beach, Florida, United States, 32117
International Medical Research
Daytona Beach, Florida, United States, 32117
Asclepius Medical Research
Doral, Florida, United States, 33166
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States, 32003
Integrative Research Associates, Inc.
Fort Lauderdale, Florida, United States, 33312
M & O Clinical Research, LLC
Fort Lauderdale, Florida, United States, 33316
Primary Care Associates
Fort Myers, Florida, United States, 33907
Florida Research Network, LLC
Gainesville, Florida, United States, 32605
George E. Platt, M.D.
Green Cove Springs, Florida, United States, 32043
Eastern Research, Inc.
Hialeah, Florida, United States, 33013
Larry K. Levinson, D.O., P.A.
Hollywood, Florida, United States, 33021
Research Physicians Network Alliance
Hollywood, Florida, United States, 33021
Pasco Cardiology Center
Hudson, Florida, United States, 34667
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
University of Florida-Jacksonville
Jacksonville, Florida, United States, 32209
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Westside Center for Clinical Research
Jacksonville, Florida, United States, 32216
Meridien Research
Lakeland, Florida, United States, 33805
Pharmax Research Clinic Inc
Miami, Florida, United States, 33126-2956
Life Spring Research Foundation
Miami, Florida, United States, 33134
United Clinical Research Corp.
Miami, Florida, United States, 33155
Cardiovascular Research Center of South Florida
Miami, Florida, United States, 33173
South Florida Research Group LLC
Miami, Florida, United States, 33176
South Florida Research Solutions
Miramar, Florida, United States, 33025
Southwest Florida Research, LLC
Naples, Florida, United States, 34102
Ocala Research Institute, INC
Ocala, Florida, United States, 34471
Oviedo Medical Research
Oviedo, Florida, United States, 32765
Cardiology Partners Clinical Research Institute
Palm Beach Gardens, Florida, United States, 33410-4304
Palm Beach Gardens Research Center
Palm Beach Gardens, Florida, United States, 33410
Research Physicians Network Alliance, Pembroke
Pembroke Pines, Florida, United States, 33025
Cardiology Consultants
Pensacola, Florida, United States, 32501-6335
Clinical Research of Central Florida
Plant City, Florida, United States, 33563
Columbia Primary Care, LLC d/b/a Heart and Health Institute
Plantation, Florida, United States, 33324
Saint Johns Center For Clinical Research
Ponte Vedra, Florida, United States, 32081
Charlotte Heart Group Research Center
Port Charlotte, Florida, United States, 33952
Progressive Medical Research
Port Orange, Florida, United States, 32127
Brevard Cardiovascular Research Associates Inc
Rockledge, Florida, United States, 32955
Clearwater Cardiovascular and Interventional Cons.
Safety Harbor, Florida, United States, 34695
Bayfront Health Saint Petersburg Research
Saint Petersburg, Florida, United States, 33701
Meridien Research - Saint Petersburg
Saint Petersburg, Florida, United States, 33709
Professional Health Care of Pinellas, Inc.
Saint Petersburg, Florida, United States, 33713
Intercoastal Medical Group
Sarasota, Florida, United States, 34239
Springfield Medical Center
Springfield, Florida, United States, 32401
Advanced Clinical Research Group
Stuart, Florida, United States, 34996
Stedman Clinical Trials
Tampa, Florida, United States, 33613
Healthpoint Medical Group, Inc
Tampa, Florida, United States, 33614
Meridien Research - Tampa
Tampa, Florida, United States, 33634
Interventional Cardiac Consultants
Trinity, Florida, United States, 34655
Lovelace Scientific Research
Venice, Florida, United States, 34292
Indian River Medical Center-Cardiology
Vero Beach, Florida, United States, 32960-3296
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States, 33449
Cleveland Clinic Foundation
West Palm Beach, Florida, United States, 33401
Metabolic Research Institute
West Palm Beach, Florida, United States, 33401
Clinical Research of Central Florida
Winter Haven, Florida, United States, 33880
United States, Georgia
Atlanta Diabetes Associates, Endocrinology
Atlanta, Georgia, United States, 30318
Rockdale Medical-Research Associates
Conyers, Georgia, United States, 30094
Atlanta Heart Specialists
Cumming, Georgia, United States, 30041
Urban Family Practice Associates/Clinical Research Advantage
Marietta, Georgia, United States, 30067
Endocrine Research Solutions, Inc
Roswell, Georgia, United States, 30076
Herman Clinical Research LLC
Suwanee, Georgia, United States, 30024
Atlanta Heart Specialists
Tucker, Georgia, United States, 30084
United States, Illinois
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, United States, 60005
Cedar-Crosse Research Center
Chicago, Illinois, United States, 60607
Northwestern University Feinberg School of Medicin
Chicago, Illinois, United States, 60611
Consultants in Cardiovascular Medicine
Elmhurst, Illinois, United States, 60126
Clinical Investigation Specialists, Inc. in Gurnee
Gurnee, Illinois, United States, 60031
Advanced CardioVascular Consultants, SC
Rock Island, Illinois, United States, 61201
United States, Indiana
Community Clinical Research Center
Anderson, Indiana, United States, 46011
American Health Network of IN, LLC, Avon
Avon, Indiana, United States, 46123
Premier Healthcare, LLC
Bloomington, Indiana, United States, 47403-3239
Deaconess Clinic, Inc.
Evansville, Indiana, United States, 47713
American Health Network of IN, LLC, Franklin
Franklin, Indiana, United States, 46131
American Health Network of IN, LLC, Greenfield
Greenfield, Indiana, United States, 46140
American Health Network - Thomas Moretto, MD
Indianapolis, Indiana, United States, 46254-5471
Medical Consultants PC
Muncie, Indiana, United States, 47303
American Health Network of IN, LLC
Muncie, Indiana, United States, 47304
Cardiology Associates of Northwest Indiana P.C.
Munster, Indiana, United States, 46321
United States, Iowa
The University of Iowa, College of Public Health
Iowa City, Iowa, United States, 52242
United States, Kansas
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States, 67203
United States, Kentucky
Norton Heart Specialists
Louisville, Kentucky, United States, 40205-3338
L-MARC Research Center
Louisville, Kentucky, United States, 40213
Research Integrity LLC
Owensboro, Kentucky, United States, 42303
United States, Maine
Central Maine Medical Center
Auburn, Maine, United States, 04210
Acadia Clinical Research, LLC.
Bangor, Maine, United States, 04401
Eastern Maine Medical Center Northeast Cardiology Associates
Bangor, Maine, United States, 04401
Southern Maine Health Care/Maine Medical Center Research Ins
Biddeford, Maine, United States, 04005
InterMed, PA
Portland, Maine, United States, 04101
United States, Maryland
Medstar Health Cardiology Associates
Annapolis, Maryland, United States, 21401
Clinical Research, Inc
Baltimore, Maryland, United States, 21204
Medstar Union Memorial Heart Specialists
Baltimore, Maryland, United States, 21218
Spectrum Clinical Research
Baltimore, Maryland, United States, 21229
Chesapeake Cardiovascular Associates, GBMC
Baltimore, Maryland, United States, 21237
Shahid Saeed MD, PC
Baltimore, Maryland, United States, 21237
Maryland Heart Associates, LLC
Glen Burnie, Maryland, United States, 21061
Klein & Associates MD PA
Hagerstown, Maryland, United States, 21740
MedStar Health Research Institute
Hyattsville, Maryland, United States, 20782
MD Medical Research
Oxon Hill, Maryland, United States, 20745
Endocrine & Metabolic Consultants
Rockville, Maryland, United States, 20852
Lutherville Personal Physicians
Towson, Maryland, United States, 21204
Overlea Personal Physicians
Towson, Maryland, United States, 21204
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
MGH Weight Center
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
New England Center for Clinical Research, IMCA
Fall River, Massachusetts, United States, 02720
Pentucket Medical Associates
Haverhill, Massachusetts, United States, 01830
ActivMed Practices
Methuen, Massachusetts, United States, 01844
Partners Community Physicians Organization
Needham, Massachusetts, United States, 02494
United States, Michigan
Endeavor Medical Research PLC
Alpena, Michigan, United States, 49707
Cadillac Clinical Research, LLC
Cadillac, Michigan, United States, 49601
Westside Family Medical Center, PC
Kalamazoo, Michigan, United States, 49009
Cardiology Consultants of East Michigan
Lapeer, Michigan, United States, 48446
Marquette General Heart and Vascular Institute
Marquette, Michigan, United States, 49855
MidMichigan Medical Center
Midland, Michigan, United States, 48670
Nisus Research at McLaren Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
Remedica, LLC
Rochester, Michigan, United States, 48307
Michigan CardioVascular Institute
Saginaw, Michigan, United States, 48601-1423
American Center for Clinical Trials
Southfield, Michigan, United States, 48034
Medical Research Associates, Inc.
Traverse City, Michigan, United States, 49684-2386
Michigan Heart
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Minneapolis Heart Institute Foundation
Baxter, Minnesota, United States, 56425
Essentia Institute of Rural Health
Duluth, Minnesota, United States, 55805
MNCOME Clinic
Eagan, Minnesota, United States, 55123
Radiant Research, Inc.
Edina, Minnesota, United States, 55435
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United States, Mississippi
Coast Cardiovascular Consultants PLLC
Gulfport, Mississippi, United States, 39501
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States, 38801
United States, Missouri
Diabetes and Endocrinology Specialists Inc
Chesterfield, Missouri, United States, 63017
BodyAesthetic Research Center
Washington, Missouri, United States, 63090
United States, Montana
Billings Clinic Research Center
Billings, Montana, United States, 59101
Montana Health Research Institute, Inc.
Billings, Montana, United States, 59102
Glacier View Cardiology PC
Kalispell, Montana, United States, 59901
United States, Nebraska
Internal Medical Associates of Grand Island, PC
Grand Island, Nebraska, United States, 68803
United States, Nevada
Clinical Research Advantage / Rita Chuang, M.D.
Henderson, Nevada, United States, 89052
Clinical Research Advantage, Inc.
Las Vegas, Nevada, United States, 89117
Clinical Research of South Nevada
Las Vegas, Nevada, United States, 89121
United States, New Jersey
Medicor Cardiology, PA
Bridgewater, New Jersey, United States, 08807-3060
Advanced Heart Care
Bridgewater, New Jersey, United States, 08807
UmiMed Center LLC
East Brunswick, New Jersey, United States, 08816
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, United States, 08318-1715
Advocare Heights Primary Care
Haddon Heights, New Jersey, United States, 08035
Cardiovascular Associates of the Delaware Valley P
Haddon Heights, New Jersey, United States, 08035
NJ Heart
Linden, New Jersey, United States, 07036
Rutgers New Jersey Medical School
Mine Hill, New Jersey, United States, 07803
Cardiovascular Associates Delaware Valley Sewell
Sewell, New Jersey, United States, 08080-1715
Cardio Metabolic Institute
Somerset, New Jersey, United States, 08873
United States, New Mexico
New Mexico Heart Institute PA
Albuquerque, New Mexico, United States, 87102
United States, New York
Albany College of Medicine, Division of Endocrinology
Albany, New York, United States, 12206
United Medical Associates, PC
Binghamton, New York, United States, 13901
Buffalo Heart Group
Buffalo, New York, United States, 14215
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, United States, 11023
Long Island Heart Associates
Mineola, New York, United States, 11501
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, United States, 11042
Weill Cornell Medical College
New York, New York, United States, 10065
DiGiovanna Institute for Medical Education
North Massapequa, New York, United States, 11758
Hudson Valley Heart Center
Poughkeepsie, New York, United States, 12601
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
Northwell Health Physician Partners Cardiology
Southampton, New York, United States, 11968
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468
Capital Cardiology Associates
Troy, New York, United States, 12180
Great Lakes Medical Research
Westfield, New York, United States, 14787
United States, North Carolina
Kernodle Clinic
Burlington, North Carolina, United States, 27215
Clinical Trials of America Inc.
Cary, North Carolina, United States, 27518
Metrolina Internal Medicine
Charlotte, North Carolina, United States, 28204
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States, 28209
Bland Clinic, PA
Greensboro, North Carolina, United States, 27401
Clinical Trials of America Inc. Hickory
Hickory, North Carolina, United States, 28601
Clinical Trials of America, Inc.
Hickory, North Carolina, United States, 28601
Peters Medical Research
High Point, North Carolina, United States, 27262
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, United States, 28557
Burke Primary Care
Morganton, North Carolina, United States, 28655
Pinehurst Medical Clinic, Inc.
Pinehurst, North Carolina, United States, 28374-8798
Wake Research Associates LLC
Raleigh, North Carolina, United States, 27612
PMG Research of Rocky Mount
Rocky Mount, North Carolina, United States, 27804
PMG Research of Salisbury
Salisbury, North Carolina, United States, 28144
Sanford Cardiology
Sanford, North Carolina, United States, 27330
Piedmont Healthcare
Statesville, North Carolina, United States, 28625
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27104
United States, North Dakota
Lillestol Research, LLC
Fargo, North Dakota, United States, 58103
United States, Ohio
Aultman Hospital
Canton, Ohio, United States, 44710
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
Sentral Clinical Research
Cincinnati, Ohio, United States, 45236
Delaware Research Group, LLC
Delaware, Ohio, United States, 43015
Awasty Research Network, LLC
Marion, Ohio, United States, 43302
Community Health Care
Massillon, Ohio, United States, 44646
Apex Medical Research Inc.
Springfield, Ohio, United States, 45505
United States, Oklahoma
Integris Cardiovascular Physicians LLC
Oklahoma City, Oklahoma, United States, 73112
Memorial Clinical Research
Oklahoma City, Oklahoma, United States, 73120
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, United States, 73135
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74104
Vital Prospects Clinical Research Institute PC
Tulsa, Oklahoma, United States, 74136-7028
United States, Pennsylvania
Blair Medical Associates
Altoona, Pennsylvania, United States, 16602
Clinical Research Associates of Central PA, LLC
Altoona, Pennsylvania, United States, 16602
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States, 17011
Geisinger Health System
Danville, Pennsylvania, United States, 17822
Doylestown Health Cardiology a Division of Doylestown Health
Doylestown, Pennsylvania, United States, 18901
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Liberty Family Practice
Erie, Pennsylvania, United States, 16508
Endocrine Clinical Research LLC
Feasterville, Pennsylvania, United States, 19053
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Lycoming Internal Medicine, Inc.
Jersey Shore, Pennsylvania, United States, 17740
Berkley Hills Clinicals
Johnstown, Pennsylvania, United States, 15905-3443
Ilumina Clinical Associates, Johnstown
Johnstown, Pennsylvania, United States, 15905
Joseph Lamantia, DO
Johnstown, Pennsylvania, United States, 15905
Comprehensive Cardiology Consultants
Langhorne, Pennsylvania, United States, 19047
Detweiler Family Medicine and Associates PC
Lansdale, Pennsylvania, United States, 19446
Green & Seidner Family Practice Associates
Lansdale, Pennsylvania, United States, 19446
Capital Area Research LLC
Newport, Pennsylvania, United States, 17074
Endocrine Metabolic Associates
Philadelphia, Pennsylvania, United States, 19114
Pottstown Medical Specialists, Inc. (PMSI)
Pottstown, Pennsylvania, United States, 19464
Geisinger Clinic
Scranton, Pennsylvania, United States, 18508
United States, Rhode Island
Partners in Cinical Research
Cumberland, Rhode Island, United States, 02864
United States, South Carolina
Radiant Research, Inc.
Greer, South Carolina, United States, 29650
Mountain View Clinical Research
Greer, South Carolina, United States, 29651
Palmetto Research Center, LLC
Spartanburg, South Carolina, United States, 29302
United States, South Dakota
Brown Clinic, PLLP
Watertown, South Dakota, United States, 57201
United States, Tennessee
PMG Research of Bristol, LLC
Bristol, Tennessee, United States, 37620
Chattanooga Research and Medicine (CHARM)
Chattanooga, Tennessee, United States, 37404
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States, 37421
Research Associates of Jackson
Jackson, Tennessee, United States, 38301-3930
Kore Cardiovascular Research
Jackson, Tennessee, United States, 38305
The Jackson Clinic, PA
Jackson, Tennessee, United States, 38305
Wellmont CVA Heart Institute
Johnson City, Tennessee, United States, 37604
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States, 37660
The Endocrine Clinic
Memphis, Tennessee, United States, 38119
Cardiology Wellness Center
Nashville, Tennessee, United States, 37203
United States, Texas
Central Texas Clinical Research, LLC
Austin, Texas, United States, 78705
Texas Diabetes & Endocrinology
Austin, Texas, United States, 78731
Texas Health Physicians Group
Carrollton, Texas, United States, 75007
Adriana Pop-Moody MD Clinic, PA
Corpus Christi, Texas, United States, 78404
Baylor Research Institute
Dallas, Texas, United States, 75204
Texas Health Physicians Group
Dallas, Texas, United States, 75218
Research Institute of Dallas
Dallas, Texas, United States, 75231
Texas Health Physicians Group, Dallas
Dallas, Texas, United States, 75243
Odilon Alvarado, M.D.
Fort Worth, Texas, United States, 76104
Texas Health Physicians Group Fort Worth
Fort Worth, Texas, United States, 76107
T and R Clinic, PA
Fort Worth, Texas, United States, 76117
San Gabriel Clinical Research, LLC
Georgetown, Texas, United States, 78626
Angiocardiac Care of Texas PA
Houston, Texas, United States, 77025-5253
Oxford Clinical Research, LLC
Houston, Texas, United States, 77074
West Houston Area Clinical Trial Consultants, LLC
Houston, Texas, United States, 77094
Endocrine and Psychiatry Center
Houston, Texas, United States, 77095
Texas Health Physicians Group
Irving, Texas, United States, 75039
Texas Cardiology Associates of Houston
Kingwood, Texas, United States, 77339
Jalil Aziz Khan M.D., P.A.
Lewisville, Texas, United States, 75067
Midland Clinical Research Center
Midland, Texas, United States, 79707
Permian Research Foundation
Odessa, Texas, United States, 79761
Medical Clinic of North Texas
Plano, Texas, United States, 75023
Clinical Investigations of Texas, LLC
Plano, Texas, United States, 75075
Texas Diabetes
Round Rock, Texas, United States, 78681
Physician PrimeCare Research Institute, PLLC
San Antonio, Texas, United States, 78228
Cardiology Clinic of San Antonio
San Antonio, Texas, United States, 78229
Radiant Research San Antonio
San Antonio, Texas, United States, 78229
Martin Diagnostic Clinic
Tomball, Texas, United States, 77375
Cardiovascular Associates of East Texas
Tyler, Texas, United States, 75701
Bay Area Total Health Medical Group
Webster, Texas, United States, 77598
United States, Utah
Advanced Research Institute
Ogden, Utah, United States, 84405
Jean Brown Research
Salt Lake City, Utah, United States, 84124
United States, Virginia
Alexandria Clinical Research, LLC
Alexandria, Virginia, United States, 22304
Washington Center for Weight Management and Resear
Arlington, Virginia, United States, 22201
Cardiology Consultants of Danville Inc.
Danville, Virginia, United States, 24541
Danville Internal Medicine, Inc.
Danville, Virginia, United States, 24541
Virginia Heart
Falls Church, Virginia, United States, 22042-1262
Seven Corners Medical Research Center
Falls Church, Virginia, United States, 22044
INOVA Health Care Services
Manassas, Virginia, United States, 20109
Burke Internal Medicine and Research
Manassas, Virginia, United States, 20110
Manassas Clinical Research Center
Manassas, Virginia, United States, 20110
Health Research of Hampton Roads - Norfolk, Inc.
Norfolk, Virginia, United States, 23502
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
Clinical Research Partners
Richmond, Virginia, United States, 23220
Virginia Cardiovascular Specialists
Richmond, Virginia, United States, 23229
National Clinical Research-Richmond, Inc.
Richmond, Virginia, United States, 23294
Selma Medical Associates
Winchester, Virginia, United States, 22601
United States, Washington
Larry D. Stonesifer, MD, Inc PS
Federal Way, Washington, United States, 98003
Seattle Women's
Seattle, Washington, United States, 98105
Rowan Research Inc.
Spokane, Washington, United States, 99218
MultiCare Research Institute
Tacoma, Washington, United States, 98405
Universal Research Group
Tacoma, Washington, United States, 98405
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Cardiology Associates of Bellin Health
Green Bay, Wisconsin, United States, 54301
Prevea Clinic, Inc.
Green Bay, Wisconsin, United States, 54303
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States, 53142
Meriter hospital Inc., DBA: UnityPoint Health-Meriter Heart
Madison, Wisconsin, United States, 53713
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Aspirus Research Institute
Wausau, Wisconsin, United States, 54401
Australia, New South Wales
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Illawarra Shoalhaven Local Health District
Wollongong, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Australia, Queensland
Core Research Group
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
HeartCare Partners Clinical Research Unit
Milton, Queensland, Australia
AusTrials Pty Ltd
Sherwood, Queensland, Australia
Gold Coast Hospital
Southport, Queensland, Australia
Australia, South Australia
Cardiology Department, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Adelaide Medical Research
Ashford, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Heart and Vascular Institute
Fullarton, South Australia, Australia
Australia, Victoria
Ballarat Health Services
Ballarat, Victoria, Australia
Geelong Cardiology Research Unit, Barwon Health
Geelong, Victoria, Australia
Austin Health - Heidelberg Repatriation Hospital
Heidelberg Heights, Victoria, Australia
Avenue Cardiovascular Centre
Saint Kilda East, Victoria, Australia
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Australia
South Australian Medical Research Inst
Adelaide, Australia
Gosford Hospital
Gosford, Australia
Joondalup Cardiovascular Trials Foundation Inc
Joondalup, Australia
The Queen Elizabeth Hospital
Woodville South, Australia
Bahamas
The Partners Clinical Research Centre
Nassau, Bahamas
Canada, Alberta
LMC Clinical Research Inc. (Calgary)
Calgary, Alberta, Canada
Canada, British Columbia
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Nova Scotia Health Authority /QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
LMC Clinical Research Inc. (Brampton)
Brampton, Ontario, Canada
McMaster University
Brampton, Ontario, Canada
Aviva Clinical Trial Group In.
Burlington, Ontario, Canada
JBN Medical Diagnostic Services Inc.
Burlington, Ontario, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, Canada
Joanne F. Liutkus Medicine Professional Corp.
Cambridge, Ontario, Canada
Saul Vizel Professional Medicine Corporation
Cambridge, Ontario, Canada
LMC Clinical Research Inc. (Etobicoke)
Etobicoke, Ontario, Canada
Wharton Medical Clinic Clinical Trials Group Inc.
Hamilton, Ontario, Canada
Saint Josephs Health Care London
London, Ontario, Canada
LMC Clinical Research Inc. (Markham)
Markham, Ontario, Canada
New Market Cardiology Research Group
Newmarket, Ontario, Canada
Dr. Michael Heffernan
Oakville, Ontario, Canada
LMC Clinical Research Inc. (Oakville)
Oakville, Ontario, Canada
Dr. Cha
Oshawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, Canada
Dr. Dinkar Shukla Professional Medicine Corporation
Sudbury, Ontario, Canada
Dr. R. Labonte Professional Medicine Corporation
Sudbury, Ontario, Canada
LMC Clinical Research Inc. (Thornhill)
Thornhill, Ontario, Canada
JJ DIG Research Ltd.
Toronto, Ontario, Canada
Keele Medical Place
Toronto, Ontario, Canada
LMC Clinical Research Inc. (Bayview)
Toronto, Ontario, Canada
St Michael's Hospital Health Centre
Toronto, Ontario, Canada
Canada, Quebec
ViaCar Recherche Clinique
Brossard, Quebec, Canada
Q&T Research Outaouais Inc.
Gatineau, Quebec, Canada
ViaCar Recherche Clinique Inc.
Greenfield Park, Quebec, Canada
Manna Research Inc
Levis, Quebec, Canada
Clinique Sante Cardio MC
Montreal, Quebec, Canada
Universitaire de Cardiologie et de Pneumologie de Quebec
Quebec City, Quebec, Canada
Centre Hospitalier Regional de Lanaudiere
Saint-Charles-Borromee, Quebec, Canada
LMC Clinical Research Inc. (Montreal)
Saint-Laurent, Quebec, Canada
Recherche Clinique London
Sherbrooke, Quebec, Canada
CardioVasc HR, Inc.
St Jean sur Richelieu, Quebec, Canada
ViaCar Recherche Clinique Inc.
St-Lambert, Quebec, Canada
Chile
Biomedica Research Group
Providencia, Santiago, Chile
Sociedad Medica Cardiologica El Llano
San Miguel, Santiago, Chile
Hospital Regional Concepcion
Concepcion, Chile
Cardiocob
Santiago, Chile
Ccbr Cecim
Santiago, Chile
Servicios Medicos Godoy Ltda.
Santiago, Chile
CECMI Ltda.
Temuco, Chile
Centro Investigacion Clinica del Sur
Temuco, Chile
Mexico
ICLE
Guadalajara, Jalisco, Mexico
Private Medical Practice
Guadalajara, Jalisco, Mexico
Cardiolink ClinTrials S.C.
Monterrey, Nuevo Leon, Mexico
Centro de Estudios Clinicos y Especialidades Medicas S.C.
Monterrey, Nuevo Leon, Mexico
IMED Clin Trials
Monterrey, Nuevo Leon, Mexico
Hospital de Angeles Xalapa
Xalapa, Veracruz, Mexico
Fundacion Cardiovascular de Aguascalientes
Aguascalientes, Mexico
Hospital Cardiologica Aguascalientes
Aguascalientes, Mexico
Mentrials S.A.de C.V.
Distrito Federal, Mexico
New Zealand
North Shore Hospital-Cardiovascular
Milford, Auckland, New Zealand
Middlemore Hospital
Papatoetoe, Auckland, New Zealand
North Shore Hospital - Diabetes
Takapuna, Auckland, New Zealand
Christchurch Hospital, Lipids
Christchurch, Canterbury, New Zealand
Christchurch Hospital
Christchurch, Canterbury, New Zealand
Dunedin Hospital
Dunedin, Otago, New Zealand
Hutt Hospital
Lower Hutt, Wellington, New Zealand
Auckland City Hospital
Auckland, New Zealand
Hawkes Bay Regional Hospital
Hastings, New Zealand
Nelson Hospital
Nelson, New Zealand
Taranaki Base Hospital
New Plymouth, New Zealand
Lakeland Clinical Trials, Rotorua
Rotorua, New Zealand
Tauranga Hospital
Tauranga, New Zealand
Poland
NZOZ "Eskulap"
Biala Rawska, Poland
Podlaski Osrodek Kardiologii Janusz Korecki
Bialystok, Poland
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
Bydgoszcz, Poland
Centrum Medyczne KERmed
Bydgoszcz, Poland
Nzoz "Mada-Med"
Chorzow, Poland
DIABET Centrum Medyczne s. c.
Chrzanow, Poland
Gabinet Kardiologiczno-Internistyczny
Gdynia, Poland
ISPL w Dziedzinie Kardiologii lek.med. Krzysztof Cymerman
Gdynia, Poland
NZOZ SCBK ProCordis
Gdynia, Poland
Praktyka Lekarska dr n. med. Marek Bronisz
Inowroclaw, Poland
Piotr Mader Diabetic Clinic NZOZ PD-I
Kamieniec Zabkowicki, Poland
NZOZ Eskulap SC
Koluszki, Poland
Ewa Mirek-Bryniarska Specjalistyczna Praktyka Lekarska
Krakow, Poland
LANDA' Specjalistyczne Gabinety Lekarskie
Krakow, Poland
Medyczne Centrum Diabetologiczno Endokrynologiczno
Krakow, Poland
Indywidualna Specjalistyczna Praktyka Lekarska
Krzekowo-Bezrzecze, Poland
SP ZOZ w Lecznej
Leczna, Poland
Nzoz Cardiamed
Legnica, Poland
NZOZ ALL-MED Centrum Medyczne
Lodz, Poland
"CenterMed Lublin" Sp. z o.o.
Lublin, Poland
Indywidualna Praktyka Lekarska
Mragowo, Poland
Zechowicz MEDEUSZ-PLUS
Olsztyn, Poland
Specjalistyczna Przychodnia Lekarska MEDIKARD (SPL Medikard)
Plock, Poland
NZOZ NEURO-KARD "Ilkowski i Partnerzy"
Poznan, Poland
Praktyka Lekarska Ewa Krzyzagorska
Poznan, Poland
Specjalistyczny Gabinet Lekarski
Tarnow, Poland
Lecznice Citomed Sp. z o.o.
Torun, Poland
Praktyka Lekarska Pawlowicz Lidia
Torun, Poland
Centrum Badawcze Wspolczesnej Terapii
Warszawa, Poland
Centrum Medyczne AMED
Warszawa, Poland
SNZOZ Fundacji PROCLINICA
Warszawa, Poland
Centrum Zdrowia Wierzchoslawice
Wierzchoslawice, Poland
Specjalistyczne Gabinety Lekarskie "Medicor PLUS"
Wloclawek, Poland
Regionalna Poradnia Diabetologiczna
Wroclaw, Poland
Sponsors and Collaborators
Eisai Inc.
Thrombolysis In Myocardial Infarction (TIMI) Academic Research Organization

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02019264     History of Changes
Other Study ID Numbers: APD356-G000-401
2013-000324-34 ( EudraCT Number )
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Eisai Inc.:
Diabetes
Cardiovascular Disease
Multiple Cardiovascular Risk Factors
Obesity
Overweight
MACE
Conversion to Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms