Obesity Clinical Trial
— CAMELLIA-TIMIOfficial 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
Verified date | November 2017 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Eisai Inc. | Thrombolysis In Myocardial Infarction (TIMI) Academic Research Organization |
United States, Australia, Bahamas, Canada, Chile, Mexico, New Zealand, Poland,
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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