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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02019264
Other study ID # APD356-G000-401
Secondary ID 2013-000324-34
Status Completed
Phase Phase 4
First received
Last updated
Start date January 24, 2014
Est. completion date May 14, 2018

Study information

Verified date November 2017
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 14673
Est. completion date May 14, 2018
Est. primary completion date May 14, 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria

1. BMI greater than or equal (>=) to 27 kilogram per meter square (kg/m^2)

2. Subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program

3. Age >= 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 >= to 55 years for women or >= to 50 years for men who have type 2 diabetes mellitus (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. Estimated glomerular filtration rate >= to 30 to less than equal (<=) to 60 mililitre per minute per 1.73 meter square (mL/min/1.73 m^) per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

4. High high sensitivity C-reactive protein (hsCRP)

5. Urinary albumin-to-creatinine ratio (ACR) >= 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 < than 20%

3. Moderate or greater symptoms of pulmonary hypertension (PH)

4. Known severe valvular disease

5. Moderate renal impairment, severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m^ per the CKD-EPI equation based on ideal body weight), or end stage renal disease (ESRD)

6. Severe hepatic impairment

7. Use of other products intended for weight loss including prescription drugs, over-the-counter (OTC) drugs, and herbal preparations

8. Use of more than one other serotonergic drug

9. Use of drugs known to increase the risk for cardiac valvulopathy within 6 months prior to Screening including, but not limited to: pergolide, ergotamine, methysergide, cabergoline

10. History or evidence of clinically significant disease (e.g., malignancy, cardiac, respiratory, gastrointestinal, renal or psychiatric disease)

11. Use of lorcaserin HCl prior to Screening or hypersensitivity to lorcaserin HCl or any of the excipients

12. Planned bariatric surgery

13. Females must not be breastfeeding or pregnant

Study Design


Intervention

Drug:
Lorcaserin hydrochloride
APD356 10 mg twice daily
Placebo
Placebo twice daily

Locations

Country Name City State
Australia New Royal Adelaide Hospital, Cardiology Department Adelaide South Australia
Australia South Australian Medical Research Inst, Centre for Clinical Research Adelaide
Australia Adelaide Medical Research Ashford South Australia
Australia Ballarat Health Services Ballarat Victoria
Australia Core Research Group Brisbane Queensland
Australia Princess Alexandra Hospital, Cardiology Research Department Brisbane Queensland
Australia Coffs Harbour Health Campus Coffs Harbour New South Wales
Australia Lyell McEwin Hospital, Department of Cardiology Elizabeth Vale South Australia
Australia Heart and Vascular Institute Fullarton South Australia
Australia Geelong Cardiology Research Unit, Barwon Health Geelong Victoria
Australia Gosford Hospital, Cardiology Clinical Trials Gosford New South Wales
Australia Austin Health - Heidelberg Repatriation Hospital, Department of Medicine, Boronia Centre Heidelberg Heights Victoria
Australia Royal Brisbane and Women's Hospital, Endocrinology Department Herston Queensland
Australia Joondalup Cardiovascular Trials Foundation Inc Joondalup Western Australia
Australia Liverpool Hospital Liverpool New South Wales
Australia HeartCare Partners Clinical Research Unit Milton Queensland
Australia Fiona Stanley Hospital, Cardiology Research Department,CDO11 Murdoch Western Australia
Australia Avenue Cardiovascular Centre Saint Kilda East Victoria
Australia AusTrials Pty Ltd Sherwood Queensland
Australia Gold Coast Hospital, Cardiovascular Research Centre Southport Queensland
Australia Illawarra Shoalhaven Local Health District, Clinical Trial and Research Unit Wollongong New South Wales
Australia Wollongong Hospital Wollongong New South Wales
Australia The Queen Elizabeth Hospital Woodville South South Australia
Bahamas The Partners Clinical Research Centre Nassau
Canada LMC Diabetes & Endocrinology - Brampton Brampton Ontario
Canada McMaster University Brampton Ontario
Canada ViaCar Recherche Clinique Brossard Quebec
Canada Aviva Clinical Trial Group In. Burlington Ontario
Canada JBN Medical Diagnostic Services Inc. Burlington Ontario
Canada LMC Clinical Research Inc. (Calgary) Calgary Alberta
Canada Cambridge Cardiac Care Centre Cambridge Ontario
Canada Joanne F. Liutkus Medicine Professional Corp. Cambridge Ontario
Canada Saul Vizel Professional Medicine Corporation, Vizel Cardiac Research Cambridge Ontario
Canada LMC Diabetes & Endocrinology (Etobicoke) Etobicoke Ontario
Canada Q&T Research Outaouais Inc. Gatineau Quebec
Canada ViaCar Recherche Clinique Inc. Greenfield Park Quebec
Canada Nova Scotia Health Authority /QEII Health Sciences Centre Halifax Nova Scotia
Canada Wharton Medical Clinic Clinical Trials Group Inc. Hamilton Ontario
Canada Manna Research Inc Levis Quebec
Canada Saint Josephs Health Care London London Ontario
Canada LMC Diabetes & Endocrinoly Markham Ontario
Canada Clinique Sante Cardio MC Montreal Quebec
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 Universitaire de Cardiologie et de Pneumologie de Quebec Quebec City Quebec
Canada Centre hospitalier régional de Lanaudière Saint-Charles-Borromee 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 Dr Roger Labonte Professional Medicine Corp Sudbury Ontario
Canada Dr. Dinkar Shukla Professional Medicine Corporation Sudbury Ontario
Canada LMC Diabetes & Endocrinology (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 Gordon and Leslie Diamond Health Care Centre Vancouver British Columbia
Canada LMC Clinical Research Inc. (Montreal) Ville Saint-Laurent Quebec
Chile Hospital Regional Concepcion Concepcion
Chile Biomedica Research Group Providencia Santiago
Chile Sociedad Medica Cardiologica El Llano San Miguel Santiago
Chile Cardiocob Santiago
Chile Ccbr Cecim Santiago
Chile Servicios Medicos Godoy Ltda. Santiago
Chile CECMI Ltda. Temuco
Chile Centro Investigacion Clinica del Sur Temuco
Mexico Fundacion Cardiovascular de Aguascalientes Aguascalientes
Mexico Hospital Cardiologica Aguascalientes Aguascalientes
Mexico Mentrials S.A.de C.V. Distrito Federal
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
New Zealand Auckland City Hospital Auckland
New Zealand Christchurch Hospital, Cardiology Research Christchurch Canterbury
New Zealand Christchurch Hospital, Lipids Christchurch Canterbury
New Zealand Dunedin Hospital Dunedin Otago
New Zealand Hawkes Bay Regional Hospital Hastings
New Zealand Hutt Hospital, Cardiology Dept Lower Hutt Wellington
New Zealand North Shore Hospital-Cardiology Research Milford Auckland
New Zealand Nelson Hospital, Cardiology Department Nelson
New Zealand Taranaki Base Hospital New Plymouth Taranaki
New Zealand Middlemore Hospital Papatoetoe Auckland
New Zealand Lakeland Clinical Trials, Rotorua Rotorua
New Zealand North Shore Hospital - Diabetes Clinic Takapuna Auckland
New Zealand Tauranga Hospital Tauranga
Poland Indywidualna Specjalistyczna Praktyka Lekarska Bezrzecze
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" Chorzów
Poland DIABET Centrum Medyczne s. c. Chrzanów
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 Kraków
Poland LANDA' Specjalistyczne Gabinety Lekarskie Kraków
Poland Medyczne Centrum Diabetologiczno Endokrynologiczno Kraków
Poland SP ZOZ w Lecznej Leczna
Poland Nzoz Cardiamed Legnica
Poland NZOZ ALL-MED Centrum Medyczne Lódz
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 Tarnów
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
United States Albany College of Medicine, Division of Endocrinology Albany New York
United States Capital Cardiology Associates Albany New York
United States New Mexico Heart Institute, PA Albuquerque New Mexico
United States Advanced Cardiovascular, LLC Alexander City Alabama
United States Alexandria Clinical Research, LLC Alexandria Virginia
United States Clinical Research Alliance Alhambra California
United States Endeavor Medical Research PLC Alpena Michigan
United States Blair Medical Associates Altoona Pennsylvania
United States Clinical Research Associates of Central PA, LLC Altoona Pennsylvania
United States Alaska Heart Institute Anchorage Alaska
United States Community Clinical Research Center Anderson Indiana
United States Medstar Cardiology Associates Annapolis Maryland
United States Washington Center for Weight Management and Resear Arlington Virginia
United States Northwest Heart Clinical Research, LLC Arlington Heights Illinois
United States North Alabama Research Center, LLC Athens Alabama
United States Atlanta Diabetes Associates, Endocrinology Atlanta Georgia
United States Central Maine Medical Center Auburn Maine
United States Central Texas Clinical Research, LLC Austin Texas
United States Texas Diabetes & Endocrinology Austin Texas
United States Aventura Heart Center Aventura Florida
United States American Health Network of IN, LLC, Avon Avon Indiana
United States Central Cardiology Bakersfield California
United States Chesapeake Cardiovascular Associates, GBMC Baltimore Maryland
United States Clinical Research, Inc Baltimore Maryland
United States Medstar Union Memorial Heart Specialists Baltimore Maryland
United States Medstar Union Memorial Hospital Baltimore Maryland
United States Overlea Personal Physicians Baltimore Maryland
United States Shahid Saeed MD, PC Baltimore Maryland
United States Spectrum Clinical Research Baltimore Maryland
United States Acadia Clinical Research, LLC Bangor Maine
United States Eastern Maine Medical Center Northeast Cardiology Associates Bangor Maine
United States Minneapolis Heart Institute Foundation Baxter Minnesota
United States Cardiovascular Research Foundation of Southern Cal Beverly Hills California
United States Southern Maine Health Care/Maine Medical Center Research Ins Biddeford Maine
United States Billings Clinic Research Center Billings Montana
United States Montana Health Research Institute, Inc. Billings Montana
United States United Medical Associates, PC Binghamton New York
United States UAB Medical Center Birmingham Alabama
United States Premier Healthcare, LLC Bloomington Indiana
United States Brigham and Women's Hospital Boston Massachusetts
United States MGH Weight Center Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Zasa Clinical Research Boynton Beach Florida
United States Meridien Research Bradenton Florida
United States NOVA Southeastern University Bradenton Florida
United States Bay Area Cardiology Brandon Florida
United States Bridgeport Hospital Bridgeport Connecticut
United States Connecticut Clinical Research, LLC Bridgeport Connecticut
United States Advanced Heart Care Bridgewater New Jersey
United States Medicor Cardiology, PA Bridgewater New Jersey
United States Clinical Research Works, Bristol Bristol Connecticut
United States PMG Research of Bristol, LLC Bristol Tennessee
United States James J. Peters VA Medical Center, Bronx, NY Bronx New York
United States Meridien Research, Brooksville Brooksville Florida
United States Buffalo Heart Group Buffalo New York
United States Burke Internal Medicine and Research Burke Virginia
United States Kernodle Clinic Burlington North Carolina
United States Cadillac Clinical Research, LLC Cadillac Michigan
United States Capital Area Research, LLC Camp Hill Pennsylvania
United States Aultman Hospital Canton Ohio
United States Capitol Interventional Cardiology Carmichael California
United States Texas Health Physicians Group Carrollton Texas
United States Clinical Trials of America Inc. Cary North Carolina
United States Connect Clinical Research Center, LCC Chandler Arizona
United States Metrolina Internal Medicine Charlotte North Carolina
United States PMG Research of Charlotte, LLC Charlotte North Carolina
United States Chattanooga Research and Medicine (CHARM) Chattanooga Tennessee
United States WR-ClinSearch, LLC Chattanooga Tennessee
United States Diabetes & Endocrinology Specialists, Inc. Chesterfield Missouri
United States Cedar-Crosse Research Center Chicago Illinois
United States Northwestern University Feinberg School of Medicine Chicago Illinois
United States University of Chicago Chicago Illinois
United States San Diego Costal Endocrinology Group AMC Chula Vista California
United States Sentral Clinical Research Cincinnati Ohio
United States The Lindner Research Center Cincinnati Ohio
United States Clearwater Cardiovascular and Interventional Cons. Clearwater Florida
United States UCH-MHS Cardiac Research Colorado Springs Colorado
United States John Muir Physician Network Clinical Research Cent Concord California
United States Rockdale Medical-Research Associates Conyers Georgia
United States Clinical Research of South Florida Coral Gables Florida
United States Holy Cross Medical Group Coral Springs Florida
United States Adriana Pop-Moody MD Clinic, PA Corpus Christi Texas
United States Partners in Clinical Research Cumberland Rhode Island
United States Atlanta Heart Specialists Cumming Georgia
United States Baylor Research Institute Dallas Texas
United States Research Institute of Dallas Dallas Texas
United States Texas Health Physicians Group Dallas Texas
United States Texas Health Physicians Group, Dallas Dallas Texas
United States Cardiology Consultants of Danville, Inc. Danville Virginia
United States Danville Internal Medicine, Inc Danville Virginia
United States Geisinger Health Clinic Danville Pennsylvania
United States Geisinger Health System Danville Pennsylvania
United States Cardiology Research Associates Daytona Beach Florida
United States International Medical Research Daytona Beach Florida
United States Delaware Research Group, LLC Delaware Ohio
United States Creekside Endocrine Associates PC Denver Colorado
United States Asclepius Medical Research Doral Florida
United States Doylestown Health Cardiology a Division of Doylestown Health Doylestown Pennsylvania
United States Essentia Institute of Rural Health Duluth Minnesota
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States MNCOME Clinic Eagan Minnesota
United States UmiMed Center LLC East Brunswick New Jersey
United States Radiant Research, Inc. Edina Minnesota
United States Cardiovascular Associates of the Delaware Valley Elmer New Jersey
United States Consultants in Cardiovascular Medicine Elmhurst Illinois
United States Medical Group of Encino Encino California
United States Regional Clinical Research, Inc. Endwell New York
United States Liberty Family Practice Erie Pennsylvania
United States Deaconess Clinic, Inc. Evansville Indiana
United States New England Center for Clinical Research, IMCA Fall River Massachusetts
United States Seven Corners Medical Research Center Falls Church Virginia
United States Virginia Heart Falls Church Virginia
United States Lillestol Research LLC Fargo North Dakota
United States Endocrine Clinical Research LLC Feasterville Pennsylvania
United States Larry D. Stonesifer, MD, Inc PS Federal Way Washington
United States Fleming Island Center for Clinical Research Fleming Island Florida
United States Integrative Research Associates, Inc. Fort Lauderdale Florida
United States M & O Clinical Research, LLC Fort Lauderdale Florida
United States Primary Care Associates Fort Myers Florida
United States Odilon Alvarado, M.D. Fort Worth Texas
United States Tand R Clinic, PA Fort Worth Texas
United States Texas Health Physicians Group Fort Worth Fort Worth Texas
United States American Health Network of IN, LLC, Franklin Franklin Indiana
United States Florida Research Network, LLC Gainesville Florida
United States San Gabriel Clinical Research, LLC Georgetown Texas
United States Maryland Heart Associates, LLC Glen Burnie Maryland
United States Arrowhead Health Centers Glendale Arizona
United States Phoenix Heart, PLLC Glendale Arizona
United States New West Physicians, PC Golden Colorado
United States Internal Medical Associates of Grand Island, PC Grand Island Nebraska
United States Long Island Gastrointestinal Research Group LLP Great Neck New York
United States Cardiology Associates of Bellin Health Green Bay Wisconsin
United States Prevea Clinic, Inc Green Bay Wisconsin
United States George E. Platt, M.D. Green Cove Springs Florida
United States Marin Endocrine Care & Research, Inc. Greenbrae California
United States Wellmont CVA Heart Institute Greeneville Tennessee
United States American Health Network of IN, LLC, Greenfield Greenfield Indiana
United States Bland Clinic, PA Greensboro North Carolina
United States Mountain View Clinical Research Greer South Carolina
United States Radiant Research, Inc. Greer South Carolina
United States Coast Cardiovascular Consultants PLLC Gulfport Mississippi
United States Clinical Investigation Specialists, Inc. in Gurnee Gurnee Illinois
United States Advocare Heights Primary Care Haddon Heights New Jersey
United States Cardiovascular Associates of the Delaware Valley P Haddon Heights New Jersey
United States Klein & Associates, MD, PA Hagerstown Maryland
United States Pentucket Medical Associates Haverhill Massachusetts
United States Clinical Research Advantage / Rita Chuang, M.D. Henderson Nevada
United States Eastern Research, Inc. Hialeah Florida
United States Clinical Trials of America Inc. Hickory Hickory North Carolina
United States Clinical Trials of America, Inc. Hickory North Carolina
United States Peters Medical Research High Point North Carolina
United States Larry K. Levinson, D.O., P.A. Hollywood Florida
United States Research Physicians Network Alliance Hollywood Florida
United States Angiocardiac Care of Texas PA Houston Texas
United States Endocrine and Psychiatry Center Houston Texas
United States Oxford Clinical Research, LLC Houston Texas
United States West Houston Area Clinical Trial Consultants, LLC Houston Texas
United States Pasco Cardiology Center Hudson Florida
United States California Heart Specialists Huntington Beach California
United States Del Rosario Medical Clinic, Inc. Huntington Park California
United States MedStar Health Research Institute Hyattsville Maryland
United States Joseph Lamantia, DO Indiana Pennsylvania
United States American Health Network - Thomas Moretto, MD Indianapolis Indiana
United States Nature Coast Clinical Research Inverness Florida
United States The University of Iowa, College of Public Health Iowa City Iowa
United States Texas Health Physicians Group Irving Texas
United States Kore Cardiovascular Research Jackson Tennessee
United States Research Associates of Jackson Jackson Tennessee
United States The Jackson Clinic, PA Jackson Tennessee
United States Jacksonville Center for Clinical Research Jacksonville Florida
United States University of Florida- Jacksonville Jacksonville Florida
United States Westside Center for Clinical Research Jacksonville Florida
United States The Clinical Trial Center, LLC Jenkintown Pennsylvania
United States Lycoming Internal Medicine, Inc. Jersey Shore Pennsylvania
United States Wellmont CVA Heart Institute Johnson City Tennessee
United States Berkley Hills Clinicals Johnstown Pennsylvania
United States Ilumina Clinical Associates, Johnstown Johnstown Pennsylvania
United States Joseph Lamantia, DO Johnstown Pennsylvania
United States NEA Baptist Clinic Jonesboro Arkansas
United States Westside Family Medical Center, PC Kalamazoo Michigan
United States Glacier View Cardiology PC Kalispell Montana
United States Clinical Investigation Specialists, Inc. Kenosha Wisconsin
United States Holston Medical Group Kingsport Tennessee
United States Wellmont CVA Heart Institute Kingsport Tennessee
United States Texas Cardiology Associates of Houston Kingwood Texas
United States Diabetes and Endocrine Associates La Mesa California
United States La Mesa Cardiac Center La Mesa California
United States Alliance Research Centers Laguna Hills California
United States Meridien Research Lakeland Florida
United States Comprehensive Cardiology Consultants Langhorne Pennsylvania
United States Detweiler Family Medicine and Associates PC Lansdale Pennsylvania
United States Green & Seidner Family Practice Associates Lansdale Pennsylvania
United States Cardiology Consultants of East Michigan Lapeer Michigan
United States Clinical Research Advantage, Inc. Las Vegas Nevada
United States Clinical Research of South Nevada Las Vegas Nevada
United States Clinical Trials of America, Inc. Lenoir North Carolina
United States Jalil Aziz Khan M.D., P.A. Lewisville Texas
United States NJ Heart Linden New Jersey
United States Arkansas Cardiology Clinic Little Rock Arkansas
United States Central Arkansas Veterans Healthcare System Little Rock Arkansas
United States Preferred Research Partners Little Rock Arkansas
United States Torrance Clinical Research Institute, Inc. Lomita California
United States Long Beach Center for Clinical Research Long Beach California
United States Beverly Hills Cardiology Los Angeles California
United States Metabolic Clinic and Research Center Los Angeles California
United States VA Greater Los Angeles Health Care System Los Angeles California
United States L-MARC Research Center Louisville Kentucky
United States Norton Heart Specialists Louisville Kentucky
United States Norton Heart Specialists Louisville Kentucky
United States University of Colorado Health Loveland Colorado
United States Lutherville Personal Physicians Lutherville Maryland
United States Meriter hospital Inc., DBA: UnityPoint Health-Meriter Heart Madison Wisconsin
United States Burke Internal Medicine and Research Manassas Virginia
United States INOVA Health Care Services Manassas Virginia
United States Manassas Clinical Research Center Manassas Virginia
United States Urban Family Practice Associates/Clinical Research Advantage Marietta Georgia
United States Awasty Research Network, LLC Marion Ohio
United States Marquette General Heart and Vascular Institute Marquette Michigan
United States Marshfield Clinic Marshfield Wisconsin
United States Community Health Care Massillon Ohio
United States The Endocrine Clinic Memphis Tennessee
United States ActivMed Practices Methuen Massachusetts
United States Cardiovascular Research Center of South Florida Miami Florida
United States Life Spring Research Foundation Miami Florida
United States Pharmax Research Clinic, Inc Miami Florida
United States South Florida Research Group LLC Miami Florida
United States United Clinical Research Corp. Miami Florida
United States Midland Clinical Research Center Midland Texas
United States MidMichigan Medical Center Midland Michigan
United States Rutgers New Jersey Medical School Mine Hill New Jersey
United States Long Island Heart Associates Mineola New York
United States Minneapolis Heart Institute Minneapolis Minnesota
United States South Florida Research Solutions Miramar Florida
United States Clinical Interventions Research Institute Mission Viejo California
United States Coastal Clinical Research, Inc. Mobile Alabama
United States Mobile Heart Specialists, PC Mobile Alabama
United States Diabetes & Endocrinology Consultants Morehead City North Carolina
United States Burke Primary Care Morganton North Carolina
United States American Health Network of IN, LLC Muncie Indiana
United States Medical Consultants PC Muncie Indiana
United States Cardiology Associates of Northwest Indiana, P.C Munster Indiana
United States Brigid Freyne MD Inc Murrieta California
United States Southwest Florida Research Naples Florida
United States Cardiology Wellness Center Nashville Tennessee
United States Partners Community Physicians Organization Natick Massachusetts
United States Partners Community Physicians Organization Needham Massachusetts
United States North Shore Diabetes and Endocrine Associates New Hyde Park New York
United States Weill Cornell Medical College New York New York
United States Red Clay Research Newark Delaware
United States Capital Area Research LLC Newport Pennsylvania
United States Clinical Research Associates of Tidewater Norfolk Virginia
United States Health Research of Hampton Roads - Norfolk, Inc. Norfolk Virginia
United States DiGiovanna Institute for Medical Education North Massapequa New York
United States Valley Clinical Trials Inc Northridge California
United States Cardiology Associates of Fairfield County, Norwalk Norwalk Connecticut
United States Ocala Research Institute, Inc Ocala Florida
United States Carr Cardiology Oceanside California
United States Permian Research Foundation Odessa Texas
United States Advanced Research Institute Ogden Utah
United States Integris Cardiovascular Physicians LLC Oklahoma City Oklahoma
United States Memorial Clinical Research Oklahoma City Oklahoma
United States South Oklahoma Heart Research, LLC Oklahoma City Oklahoma
United States Oviedo Medical Research Oviedo Florida
United States Research Integrity LLC Owensboro Kentucky
United States MD Medical Research Oxon Hill Maryland
United States Cardiology Partners Clinical Research Institute Palm Beach Gardens Florida
United States Palm Beach Gardens Research Center Palm Beach Gardens Florida
United States Research Physicians Network Alliance, Pembrok Pembroke Pines Florida
United States South Florida Research Solutions Pembroke Pines Florida
United States Cardiology Consultants Pensacola Florida
United States Nisus Research at McLaren Northern Michigan Hospital Petoskey Michigan
United States Endocrine Metabolic Associates Philadelphia Pennsylvania
United States Pinehurst Medical Clinic, Inc. Pinehurst North Carolina
United States Clinical Investigations of Texas, LLC Plano Texas
United States Medical Clinic of North Texas Plano Texas
United States Clinical Research of Central Florida Plant City Florida
United States Columbia Primary Care, LLC d/b/a Heart and Health Institute Plantation Florida
United States St Johns Center for Clinical Research Ponte Vedra Florida
United States Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Charlotte Heart Group Research Center Port Charlotte Florida
United States Progressive Medical Research Port Orange Florida
United States InterMed, PA Portland Maine
United States Pottstown Medical Specialists, Inc. (PMSI) Pottstown Pennsylvania
United States Hudson Valley Heart Center Poughkeepsie New York
United States Wake Research Associates, LLC Raleigh North Carolina
United States Northern California Clinical Research Center Redding California
United States Clinical Research Partners Richmond Virginia
United States National Clinical Research-Richmond, Inc Richmond Virginia
United States Virginia Cardiovascular Specialists Richmond Virginia
United States Remedica LLC Rochester Michigan
United States Rochester Clinical Research, Inc. Rochester New York
United States Advanced CardioVascular Consultants, SC Rock Island Illinois
United States Brevard Cardiovascular Research Associates Inc Rockledge Florida
United States Endocrine & Metabolic Consultants Rockville Maryland
United States PMG Research of Rocky Mount Rocky Mount North Carolina
United States Endocrine Research Solutions, Inc. Roswell Georgia
United States Texas Diabetes Round Rock Texas
United States Clearwater Cardiovascular and Interventional Cons. Safety Harbor Florida
United States Michigan CardioVascular Institute Saginaw Michigan
United States Regions Hospital Saint Paul Minnesota
United States Bayfront Health St. Petersburg, Research Saint Petersburg Florida
United States Meridien Research - St. Petersburg Saint Petersburg Florida
United States Professional Health Care of Pinellas, INC Saint Petersburg Florida
United States PMG Research of Salisbury Salisbury North Carolina
United States Jean Brown Research Salt Lake City Utah
United States Cardiology Clinic of San Antonio San Antonio Texas
United States Physician PrimeCare Research Institute, PLLC San Antonio Texas
United States Radiant Research San Antonio San Antonio Texas
United States Ritchken and First MD's San Diego California
United States Sharp Rees-Stealy Medical Group, Inc. San Diego California
United States University of California San Diego San Diego California
United States West Coast Research LLC San Ramon California
United States Sanford Cardiology Sanford North Carolina
United States Coastal Multi-Specialty Research Santa Ana California
United States Intercoastal Medical Group Sarasota Florida
United States Geisinger Clinic Scranton Pennsylvania
United States Seattle Women's Seattle Washington
United States Cardiovascular Associates Delaware Valley Sewell Sewell New Jersey
United States Cardio Metabolic Institute Somerset New Jersey
United States Northwell Health Physician Partners Cardiology Southampton New York
United States American Center for Clinical Trials Southfield Michigan
United States Palmetto Research Center, LLC Spartanburg South Carolina
United States Rowan Research Inc. Spokane Washington
United States Apex Medical Research Inc. Springfield Ohio
United States Springfield Medical Center Springfield Florida
United States Cardiology Associates of Fairfield County, P.C. Stamford Connecticut
United States Stamford Therapeutics Consortium Stamford Connecticut
United States Piedmont Healthcare Statesville North Carolina
United States Advanced Clinical Research Group Stuart Florida
United States Herman Clinical Research LLC Suwanee Georgia
United States MultiCare Research Institute Tacoma Washington
United States Universal Research Group Tacoma Washington
United States Healthpoint Medical Group, Inc Tampa Florida
United States Meridien Research - Tampa Tampa Florida
United States Stedman Clinical Trials Tampa Florida
United States Westlake Medical Research Thousand Oaks California
United States Martin Diagnostic Clinic Tomball Texas
United States Harbor - UCLA Medical Center Torrance California
United States Lutherville Personal Physicians Towson Maryland
United States Overlea Personal Physicians Towson Maryland
United States Medical Research Associates, Inc. Traverse City Michigan
United States Interventional Cardiac Consultants Trinity Florida
United States Capital Cardiology Associates Troy New York
United States Cardiology Associates of Fairfield County, P.C. Trumbull Connecticut
United States Connecticut Heart and Vascular Center Trumbull Connecticut
United States Atlanta Heart Specialists Tucker Georgia
United States Eclipse Clinical Research Tucson Arizona
United States Oklahoma Heart Institute Tulsa Oklahoma
United States Vital Prospects Clinical Research Institute PC Tulsa Oklahoma
United States Cardiology Associates Research, LLC Tupelo Mississippi
United States Cardiovascular Associates of East Texas Tyler Texas
United States Lovelace Scientific Research Venice Florida
United States Ronald Chochinov, MD Ventura California
United States Ventura Cardiology Consultants Ventura California
United States Indian River Medical Center-Cardiology Vero Beach Florida
United States BodyAesthetic Research Center Washington Missouri
United States Chase Medical Research, LLC Waterbury Connecticut
United States Brown Clinic, PLLP Watertown South Dakota
United States Aspirus Research Institute Wausau Wisconsin
United States Bay Area Total Health Medical Group Webster Texas
United States Cardiology Partners Clinical Research Institute Wellington Florida
United States Wenatchee Valley Hospital & Clinics Wenatchee Washington
United States Infosphere Clinical Research West Hills California
United States Cleveland Clinic Foundation West Palm Beach Florida
United States Metabolic Research Institute West Palm Beach Florida
United States Great Lakes Medical Research Westfield New York
United States Professional Research Network of Kansas, LLC Wichita Kansas
United States Alfieri Cardiology Wilmington Delaware
United States PMG Research of Wilmington Wilmington North Carolina
United States Selma Medical Associates Winchester Virginia
United States PMG Research of Winston-Salem, LLC Winston-Salem North Carolina
United States Clinical Research of Central Florida Winter Haven Florida
United States Michigan Heart Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
Eisai Inc. Thrombolysis In Myocardial Infarction (TIMI) Academic Research Organization

Countries where clinical trial is conducted

United States,  Australia,  Bahamas,  Canada,  Chile,  Mexico,  New Zealand,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis The MACE events involved myocardial infarction (MI), stroke, or cardiovascular (CV) death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Baseline up to Month 42
Primary Time From Randomization to First Occurrence of MACE+ The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or heart failure (HF), or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Baseline up to end of study (Month 56)
Secondary Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Participants With Prediabetes at Baseline Time from randomization to conversion to T2DM was defined as first occurrence of any component of the 2013 American Diabetes Association (ADA) Diagnostic Criteria (ADA, 2013) in participants with prediabetes at baseline. The diagnostic criteria were met if a participant had unequivocal hyperglycemia (random plasma glucose greater than or equal to (>=) 200 milligram per deciliter (mg/dL) (11.1 millimole per liter [mmol/L]) with classic symptoms of hyperglycemia or hyperglycemic crisis) or any of the following criteria were observed and subsequently confirmed on repeat laboratory testing such as: glycosylated hemoglobin (HbA1c) >=to 6.5%; fasting plasma glucose (FPG) >=126 mg/dL (7.0 mmol/L); 2-hour plasma glucose >=200 mg/dL (11.1 mmol/L) by an oral glucose tolerance test (OGTT). The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Baseline up to end of study (Month 56)
Secondary Time From Randomization to First Occurrence of the Individual Components of MACE+ The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or HF, or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Baseline up to end of study (Month 56)
Secondary Time From Randomization to Event of All-cause Mortality The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Baseline up to end of study (Month 56)
Secondary Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline Normal glucose homeostasis was defined as HbA1c less than or equal to (<=) 5.6% and FPG < 100 mg/dL without any antidiabetic treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Baseline up to end of study (Month 56)
Secondary Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Baseline up to end of study (Month 56)
Secondary Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline Baseline, and Month 6
Secondary Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (albumin-to-creatinine ratio [ACR] >=30mcg/mg and ACR>=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at Baseline developed macroalbuminuria, ACR increased >=30% from Baseline during treatment), newly developed chronic kidney disease (CKD) (eGFR >=90 milliliter per minute per 1.73 [mL/min/1.73]body surface area (BSA) and without kidney damage at Baseline changed to CKD Stage 1/higher as per National Kidney Foundation [NKF] Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times Baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Baseline up to end of study (Month 56)
Secondary Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR >=30mcg/mg and ACR >=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased >=30% from baseline during treatment), CKD (eGFR >=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Baseline up to end of study (Month 56)
Secondary Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR >=30 mcg/mg and ACR >=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased >=30% from baseline during treatment), CKD (eGFR >=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Baseline up to end of study (Month 56)
Secondary Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline Improvement in renal function was defined as first occurrence of regression of albuminuria or regression of CKD. Regression of albuminuria was defined as when participants with macroalbuminuria at baseline developed microalbuminuria or nonalbuminuria (ACR <30 mcg/mg in spot urine), or participants with microalbuminuria at baseline became nonalbuminuric, and ACR value decreased >= 30% from previous assessment during treatment. Regression of CKD defined as when participants with CKD Stage 1 or higher at baseline improved to normal or lower stages by NKF guidelines (eGFR >=90 with albuminuria at baseline improved to eGFR >=90 without albuminuria, or eGFR 60 to 89 at baseline became eGFR >=90 with or without albuminuria, or eGFR between 30 to 59 at baseline improved to >60 mL/min/1.73 BSA) during treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Baseline up to end of study (Month 56)
Secondary Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes Months 6 and 12
Secondary Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy Months 6 and 12
Secondary Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure Baseline, Month 12
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