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Clinical Trial Details

Trial ID: L5078
Source ID: NCT02019264
Associated Drug: Lorcaserin Hydrochloride
Title: A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
Acronym: CAMELLIA-TIMI
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02019264/results
Conditions: Cardiovascular Disease|High Cardiovascular Risk|Obesity|Overweight|Type 2 Diabetes
Interventions: DRUG: Lorcaserin hydrochloride|DRUG: Placebo
Outcome Measures: 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|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)|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)|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)|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)|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)|Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline, Baseline, and Month 6|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)|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)|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)|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)|Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes, Months 6 and 12|Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy, Months 6 and 12|Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure, Baseline, Month 12
Sponsor/Collaborators: Sponsor: Eisai Inc. | Collaborators: The TIMI Study Group
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 14673
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-01-24
Completion Date: 2018-05-14
Results First Posted: 2019-07-16
Last Update Posted: 2019-07-16
Locations: Advanced Cardiovascular, LLC, Alexander City, Alabama, 35010, United States|North Alabama Research Center, LLC, Athens, Alabama, 35611, United States|UAB Medical Center, Birmingham, Alabama, 35294, United States|Coastal Clinical Research, Inc., Mobile, Alabama, 36608, United States|Mobile Heart Specialists, PC, Mobile, Alabama, 36608, United States|Alaska Heart Institute, Anchorage, Alaska, 99508, United States|Connect Clinical Research Center, LCC, Chandler, Arizona, 85224, United States|Arrowhead Health Centers, Glendale, Arizona, 85306, United States|Phoenix Heart, PLLC, Glendale, Arizona, 85306, United States|Eclipse Clinical Research, Tucson, Arizona, 85745, United States|NEA Baptist Clinic, Jonesboro, Arkansas, 72401, United States|Arkansas Cardiology Clinic, Little Rock, Arkansas, 72205, United States|Central Arkansas Veterans Healthcare System, Little Rock, Arkansas, 72205, United States|Preferred Research Partners, Little Rock, Arkansas, 72211, United States|Clinical Research Alliance, Alhambra, California, 91801, United States|Central Cardiology, Bakersfield, California, 93308, United States|Cardiovascular Research Foundation of Southern Cal, Beverly Hills, California, 90210, United States|Capitol Interventional Cardiology, Carmichael, California, 95608, United States|San Diego Costal Endocrinology Group AMC, Chula Vista, California, 91911 3813, United States|John Muir Physician Network Clinical Research Cent, Concord, California, 94520, United States|Medical Group of Encino, Encino, California, 91436, United States|Marin Endocrine Care & Research, Inc., Greenbrae, California, 94904, United States|California Heart Specialists, Huntington Beach, California, 92648, United States|Del Rosario Medical Clinic, Inc., Huntington Park, California, 90255, United States|Diabetes and Endocrine Associates, La Mesa, California, 91942, United States|La Mesa Cardiac Center, La Mesa, California, 91942, United States|Alliance Research Centers, Laguna Hills, California, 92653, United States|Torrance Clinical Research Institute, Inc., Lomita, California, 90717, United States|Long Beach Center for Clinical Research, Long Beach, California, 90807, United States|Metabolic Clinic and Research Center, Los Angeles, California, 90033, United States|Beverly Hills Cardiology, Los Angeles, California, 90067, United States|VA Greater Los Angeles Health Care System, Los Angeles, California, 90073, United States|Clinical Interventions Research Institute, Mission Viejo, California, 92692, United States|Brigid Freyne MD Inc, Murrieta, California, 92563, United States|Valley Clinical Trials Inc, Northridge, California, 91325, United States|Carr Cardiology, Oceanside, California, 92056, United States|Northern California Clinical Research Center, Redding, California, 96001, United States|Sharp Rees-Stealy Medical Group, Inc., San Diego, California, 92101, United States|University of California San Diego, San Diego, California, 92103, United States|Ritchken and First MD's, San Diego, California, 92117, United States|West Coast Research LLC, San Ramon, California, 94582, United States|Coastal Multi-Specialty Research, Santa Ana, California, 92704, United States|Westlake Medical Research, Thousand Oaks, California, 91360, United States|Harbor - UCLA Medical Center, Torrance, California, 90509, United States|Ronald Chochinov, MD, Ventura, California, 93003, United States|Ventura Cardiology Consultants, Ventura, California, 93003, United States|Infosphere Clinical Research, West Hills, California, 91307, United States|UCH-MHS Cardiac Research, Colorado Springs, Colorado, 80909, United States|Creekside Endocrine Associates PC, Denver, Colorado, 80209, United States|New West Physicians, PC, Golden, Colorado, 80401, United States|University of Colorado Health, Loveland, Colorado, 80538, United States|Connecticut Clinical Research, LLC, Bridgeport, Connecticut, 06606, United States|Bridgeport Hospital, Bridgeport, Connecticut, 06610, United States|Clinical Research Works, Bristol, Bristol, Connecticut, 06010-5103, United States|Cardiology Associates of Fairfield County, Norwalk, Norwalk, Connecticut, 06851, United States|Cardiology Associates of Fairfield County, P.C., Stamford, Connecticut, 06905, United States|Stamford Therapeutics Consortium, Stamford, Connecticut, 06905, United States|Cardiology Associates of Fairfield County, P.C., Trumbull, Connecticut, 06611, United States|Connecticut Heart and Vascular Center, Trumbull, Connecticut, 06611, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Red Clay Research, Newark, Delaware, 19713, United States|Alfieri Cardiology, Wilmington, Delaware, 19803-3733, United States|Aventura Heart Center, Aventura, Florida, 33180, United States|Zasa Clinical Research, Boynton Beach, Florida, 33427, United States|Meridien Research, Bradenton, Florida, 34201, United States|NOVA Southeastern University, Bradenton, Florida, 34209, United States|Bay Area Cardiology, Brandon, Florida, 33511, United States|Meridien Research, Brooksville, Brooksville, Florida, 34601, United States|Clearwater Cardiovascular and Interventional Cons., Clearwater, Florida, 33756, United States|Clinical Research of South Florida, Coral Gables, Florida, 33143, United States|Holy Cross Medical Group, Coral Springs, Florida, 33065, United States|Cardiology Research Associates, Daytona Beach, Florida, 32117, United States|International Medical Research, Daytona Beach, Florida, 32117, United States|Asclepius Medical Research, Doral, Florida, 33166, United States|Fleming Island Center for Clinical Research, Fleming Island, Florida, 32003, United States|Integrative Research Associates, Inc., Fort Lauderdale, Florida, 33312, United States|M & O Clinical Research, LLC, Fort Lauderdale, Florida, 33316, United States|Primary Care Associates, Fort Myers, Florida, 33907, United States|Florida Research Network, LLC, Gainesville, Florida, 32605, United States|George E. Platt, M.D., Green Cove Springs, Florida, 32043, United States|Eastern Research, Inc., Hialeah, Florida, 33013, United States|Larry K. Levinson, D.O., P.A., Hollywood, Florida, 33021, United States|Research Physicians Network Alliance, Hollywood, Florida, 33021, United States|Pasco Cardiology Center, Hudson, Florida, 34667, United States|Nature Coast Clinical Research, Inverness, Florida, 34452, United States|University of Florida- Jacksonville, Jacksonville, Florida, 32209, United States|Jacksonville Center for Clinical Research, Jacksonville, Florida, 32216, United States|Westside Center for Clinical Research, Jacksonville, Florida, 32216, United States|Meridien Research, Lakeland, Florida, 33805, United States|Pharmax Research Clinic, Inc, Miami, Florida, 33126-2956, United States|Life Spring Research Foundation, Miami, Florida, 33134, United States|United Clinical Research Corp., Miami, Florida, 33155, United States|Cardiovascular Research Center of South Florida, Miami, Florida, 33173, United States|South Florida Research Group LLC, Miami, Florida, 33176, United States|South Florida Research Solutions, Miramar, Florida, 33025, United States|Southwest Florida Research, Naples, Florida, 34102, United States|Ocala Research Institute, Inc, Ocala, Florida, 34471, United States|Oviedo Medical Research, Oviedo, Florida, 32765, United States|Cardiology Partners Clinical Research Institute, Palm Beach Gardens, Florida, 33410-4304, United States|Palm Beach Gardens Research Center, Palm Beach Gardens, Florida, 33410, United States|Research Physicians Network Alliance, Pembrok, Pembroke Pines, Florida, 33025, United States|South Florida Research Solutions, Pembroke Pines, Florida, 33028, United States|Cardiology Consultants, Pensacola, Florida, 32501 6335, United States|Clinical Research of Central Florida, Plant City, Florida, 33563, United States|Columbia Primary Care, LLC d/b/a Heart and Health Institute, Plantation, Florida, 33324, United States|St Johns Center for Clinical Research, Ponte Vedra, Florida, 32081, United States|Charlotte Heart Group Research Center, Port Charlotte, Florida, 33952, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|Brevard Cardiovascular Research Associates Inc, Rockledge, Florida, 32955, United States|Clearwater Cardiovascular and Interventional Cons., Safety Harbor, Florida, 34695, United States|Bayfront Health St. Petersburg, Research, Saint Petersburg, Florida, 33701, United States|Meridien Research - St. Petersburg, Saint Petersburg, Florida, 33709, United States|Professional Health Care of Pinellas, INC, Saint Petersburg, Florida, 33713, United States|Intercoastal Medical Group, Sarasota, Florida, 34239, United States|Springfield Medical Center, Springfield, Florida, 32401, United States|Advanced Clinical Research Group, Stuart, Florida, 34996, United States|Meridien Research - Tampa, Tampa, Florida, 33606, United States|Stedman Clinical Trials, Tampa, Florida, 33613, United States|Healthpoint Medical Group, Inc, Tampa, Florida, 33614, United States|Interventional Cardiac Consultants, Trinity, Florida, 34655, United States|Lovelace Scientific Research, Venice, Florida, 34292, United States|Indian River Medical Center-Cardiology, Vero Beach, Florida, 32960-3296, United States|Cardiology Partners Clinical Research Institute, Wellington, Florida, 33449, United States|Cleveland Clinic Foundation, West Palm Beach, Florida, 33401, United States|Metabolic Research Institute, West Palm Beach, Florida, 33401, United States|Clinical Research of Central Florida, Winter Haven, Florida, 33880, United States|Atlanta Diabetes Associates, Endocrinology, Atlanta, Georgia, 30318, United States|Rockdale Medical-Research Associates, Conyers, Georgia, 30094, United States|Atlanta Heart Specialists, Cumming, Georgia, 30041, United States|Urban Family Practice Associates/Clinical Research Advantage, Marietta, Georgia, 30067, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|Herman Clinical Research LLC, Suwanee, Georgia, 30024, United States|Atlanta Heart Specialists, Tucker, Georgia, 30084, United States|Northwest Heart Clinical Research, LLC, Arlington Heights, Illinois, 60005, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Northwestern University Feinberg School of Medicine, Chicago, Illinois, 60611, United States|University of Chicago, Chicago, Illinois, 60637, United States|Consultants in Cardiovascular Medicine, Elmhurst, Illinois, 60126, United States|Clinical Investigation Specialists, Inc. in Gurnee, Gurnee, Illinois, 60031, United States|Advanced CardioVascular Consultants, SC, Rock Island, Illinois, 61201, United States|Community Clinical Research Center, Anderson, Indiana, 46011, United States|American Health Network of IN, LLC, Avon, Avon, Indiana, 46123, United States|Premier Healthcare, LLC, Bloomington, Indiana, 47403 3239, United States|Deaconess Clinic, Inc., Evansville, Indiana, 47713, United States|American Health Network of IN, LLC, Franklin, Franklin, Indiana, 46131, United States|American Health Network of IN, LLC, Greenfield, Greenfield, Indiana, 46140, United States|American Health Network - Thomas Moretto, MD, Indianapolis, Indiana, 46254-5471, United States|Medical Consultants PC, Muncie, Indiana, 47303, United States|American Health Network of IN, LLC, Muncie, Indiana, 47304, United States|Cardiology Associates of Northwest Indiana, P.C, Munster, Indiana, 46321, United States|The University of Iowa, College of Public Health, Iowa City, Iowa, 52242, United States|Professional Research Network of Kansas, LLC, Wichita, Kansas, 67203, United States|Norton Heart Specialists, Louisville, Kentucky, 40205 3338, United States|Norton Heart Specialists, Louisville, Kentucky, 40205-3338, United States|L-MARC Research Center, Louisville, Kentucky, 40213, United States|Research Integrity LLC, Owensboro, Kentucky, 42303, United States|Central Maine Medical Center, Auburn, Maine, 04210, United States|Acadia Clinical Research, LLC, Bangor, Maine, 04401, United States|Eastern Maine Medical Center Northeast Cardiology Associates, Bangor, Maine, 04401, United States|Southern Maine Health Care/Maine Medical Center Research Ins, Biddeford, Maine, 04005, United States|InterMed, PA, Portland, Maine, 04101, United States|Medstar Cardiology Associates, Annapolis, Maryland, 21401, United States|Chesapeake Cardiovascular Associates, GBMC, Baltimore, Maryland, 21204, United States|Clinical Research, Inc, Baltimore, Maryland, 21204, United States|Medstar Union Memorial Heart Specialists, Baltimore, Maryland, 21218, United States|Medstar Union Memorial Hospital, Baltimore, Maryland, 21218, United States|Spectrum Clinical Research, Baltimore, Maryland, 21229, United States|Overlea Personal Physicians, Baltimore, Maryland, 21236, United States|Shahid Saeed MD, PC, Baltimore, Maryland, 21237, United States|Maryland Heart Associates, LLC, Glen Burnie, Maryland, 21061, United States|Klein & Associates, MD, PA, Hagerstown, Maryland, 21740, United States|MedStar Health Research Institute, Hyattsville, Maryland, 20782, United States|Lutherville Personal Physicians, Lutherville, Maryland, 21093, United States|MD Medical Research, Oxon Hill, Maryland, 20745, United States|Endocrine & Metabolic Consultants, Rockville, Maryland, 20852, United States|Lutherville Personal Physicians, Towson, Maryland, 21204, United States|Overlea Personal Physicians, Towson, Maryland, 21204, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|MGH Weight Center, Boston, Massachusetts, 02114, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States|New England Center for Clinical Research, IMCA, Fall River, Massachusetts, 02720, United States|Pentucket Medical Associates, Haverhill, Massachusetts, 01830, United States|ActivMed Practices, Methuen, Massachusetts, 01844, United States|Partners Community Physicians Organization, Natick, Massachusetts, 01760, United States|Partners Community Physicians Organization, Needham, Massachusetts, 02494, United States|Endeavor Medical Research PLC, Alpena, Michigan, 49707, United States|Cadillac Clinical Research, LLC, Cadillac, Michigan, 49601, United States|Westside Family Medical Center, PC, Kalamazoo, Michigan, 49009, United States|Cardiology Consultants of East Michigan, Lapeer, Michigan, 48446, United States|Marquette General Heart and Vascular Institute, Marquette, Michigan, 49855, United States|MidMichigan Medical Center, Midland, Michigan, 48670, United States|Nisus Research at McLaren Northern Michigan Hospital, Petoskey, Michigan, 49770, United States|Saint Joseph Mercy Oakland Hospital, Pontiac, Michigan, 48341-2985, United States|Remedica LLC, Rochester, Michigan, 48307, United States|Michigan CardioVascular Institute, Saginaw, Michigan, 48601 1423, United States|American Center for Clinical Trials, Southfield, Michigan, 48034, United States|Medical Research Associates, Inc., Traverse City, Michigan, 49684-2386, United States|Michigan Heart, Ypsilanti, Michigan, 48197, United States|Minneapolis Heart Institute Foundation, Baxter, Minnesota, 56425, United States|Essentia Institute of Rural Health, Duluth, Minnesota, 55805, United States|MNCOME Clinic, Eagan, Minnesota, 55123, United States|Radiant Research, Inc., Edina, Minnesota, 55435, United States|Minneapolis Heart Institute, Minneapolis, Minnesota, 55407, United States|Regions Hospital, Saint Paul, Minnesota, 55101, United States|Coast Cardiovascular Consultants PLLC, Gulfport, Mississippi, 39501, United States|Cardiology Associates Research, LLC, Tupelo, Mississippi, 38801, United States|Diabetes & Endocrinology Specialists, Inc., Chesterfield, Missouri, 63017, United States|BodyAesthetic Research Center, Washington, Missouri, 63090, United States|Billings Clinic Research Center, Billings, Montana, 59101, United States|Montana Health Research Institute, Inc., Billings, Montana, 59102, United States|Glacier View Cardiology PC, Kalispell, Montana, 59901, United States|Internal Medical Associates of Grand Island, PC, Grand Island, Nebraska, 68803, United States|Clinical Research Advantage / Rita Chuang, M.D., Henderson, Nevada, 89052, United States|Clinical Research Advantage, Inc., Las Vegas, Nevada, 89117, United States|Clinical Research of South Nevada, Las Vegas, Nevada, 89121, United States|Medicor Cardiology, PA, Bridgewater, New Jersey, 08807-3060, United States|Advanced Heart Care, Bridgewater, New Jersey, 08807, United States|UmiMed Center LLC, East Brunswick, New Jersey, 08816, United States|Cardiovascular Associates of the Delaware Valley, Elmer, New Jersey, 08318-1715, United States|Advocare Heights Primary Care, Haddon Heights, New Jersey, 08035, United States|Cardiovascular Associates of the Delaware Valley P, Haddon Heights, New Jersey, 08035, United States|NJ Heart, Linden, New Jersey, 07036, United States|Rutgers New Jersey Medical School, Mine Hill, New Jersey, 07103, United States|Cardiovascular Associates Delaware Valley Sewell, Sewell, New Jersey, 08080-1715, United States|Cardio Metabolic Institute, Somerset, New Jersey, 08873, United States|New Mexico Heart Institute, PA, Albuquerque, New Mexico, 87102, United States|Albany College of Medicine, Division of Endocrinology, Albany, New York, 12206, United States|Capital Cardiology Associates, Albany, New York, 12211, United States|United Medical Associates, PC, Binghamton, New York, 13901, United States|James J. Peters VA Medical Center, Bronx, NY, Bronx, New York, 10468, United States|Buffalo Heart Group, Buffalo, New York, 14215, United States|Regional Clinical Research, Inc., Endwell, New York, 13760, United States|Long Island Gastrointestinal Research Group LLP, Great Neck, New York, 11023, United States|Long Island Heart Associates, Mineola, New York, 11501, United States|North Shore Diabetes and Endocrine Associates, New Hyde Park, New York, 11042, United States|Weill Cornell Medical College, New York, New York, 10065, United States|DiGiovanna Institute for Medical Education, North Massapequa, New York, 11758, United States|Hudson Valley Heart Center, Poughkeepsie, New York, 12601, United States|Rochester Clinical Research, Inc., Rochester, New York, 14609, United States|Northwell Health Physician Partners Cardiology, Southampton, New York, 11968, United States|Capital Cardiology Associates, Troy, New York, 12180, United States|Great Lakes Medical Research, Westfield, New York, 14787, United States|Kernodle Clinic, Burlington, North Carolina, 27215, United States|Clinical Trials of America Inc., Cary, North Carolina, 27518, United States|Metrolina Internal Medicine, Charlotte, North Carolina, 28204, United States|PMG Research of Charlotte, LLC, Charlotte, North Carolina, 28209, United States|Bland Clinic, PA, Greensboro, North Carolina, 27401, United States|Clinical Trials of America Inc. Hickory, Hickory, North Carolina, 28601, United States|Clinical Trials of America, Inc., Hickory, North Carolina, 28601, United States|Peters Medical Research, High Point, North Carolina, 27262, United States|Clinical Trials of America, Inc., Lenoir, North Carolina, 28645, United States|Diabetes & Endocrinology Consultants, Morehead City, North Carolina, 28557, United States|Burke Primary Care, Morganton, North Carolina, 28655, United States|Pinehurst Medical Clinic, Inc., Pinehurst, North Carolina, 28374-8798, United States|Wake Research Associates, LLC, Raleigh, North Carolina, 27612, United States|PMG Research of Rocky Mount, Rocky Mount, North Carolina, 27804, United States|PMG Research of Salisbury, Salisbury, North Carolina, 28144, United States|Sanford Cardiology, Sanford, North Carolina, 27330, United States|Piedmont Healthcare, Statesville, North Carolina, 28625, United States|PMG Research of Wilmington, Wilmington, North Carolina, 28401, United States|PMG Research of Winston-Salem, LLC, Winston-Salem, North Carolina, 27103, United States|Lillestol Research LLC, Fargo, North Dakota, 58103, United States|Aultman Hospital, Canton, Ohio, 44710, United States|The Lindner Research Center, Cincinnati, Ohio, 45219, United States|Sentral Clinical Research, Cincinnati, Ohio, 45236, United States|Delaware Research Group, LLC, Delaware, Ohio, 43015, United States|Awasty Research Network, LLC, Marion, Ohio, 43302, United States|Community Health Care, Massillon, Ohio, 44646, United States|Apex Medical Research Inc., Springfield, Ohio, 45505, United States|Integris Cardiovascular Physicians LLC, Oklahoma City, Oklahoma, 73112, United States|Memorial Clinical Research, Oklahoma City, Oklahoma, 73120, United States|South Oklahoma Heart Research, LLC, Oklahoma City, Oklahoma, 73135, United States|Oklahoma Heart Institute, Tulsa, Oklahoma, 74104, United States|Vital Prospects Clinical Research Institute PC, Tulsa, Oklahoma, 74136 7028, United States|Blair Medical Associates, Altoona, Pennsylvania, 16602, United States|Clinical Research Associates of Central PA, LLC, Altoona, Pennsylvania, 16602, United States|Capital Area Research, LLC, Camp Hill, Pennsylvania, 17011, United States|Geisinger Health Clinic, Danville, Pennsylvania, 17822, United States|Geisinger Health System, Danville, Pennsylvania, 17822, United States|Doylestown Health Cardiology a Division of Doylestown Health, Doylestown, Pennsylvania, 18901, United States|Altoona Center for Clinical Research, Duncansville, Pennsylvania, 16635, United States|Liberty Family Practice, Erie, Pennsylvania, 16508, United States|Endocrine Clinical Research LLC, Feasterville, Pennsylvania, 19053, United States|Joseph Lamantia, DO, Indiana, Pennsylvania, 15701, United States|The Clinical Trial Center, LLC, Jenkintown, Pennsylvania, 19046, United States|Lycoming Internal Medicine, Inc., Jersey Shore, Pennsylvania, 17740, United States|Berkley Hills Clinicals, Johnstown, Pennsylvania, 15905-3443, United States|Ilumina Clinical Associates, Johnstown, Johnstown, Pennsylvania, 15905, United States|Joseph Lamantia, DO, Johnstown, Pennsylvania, 15905, United States|Comprehensive Cardiology Consultants, Langhorne, Pennsylvania, 19047, United States|Detweiler Family Medicine and Associates PC, Lansdale, Pennsylvania, 19446, United States|Green & Seidner Family Practice Associates, Lansdale, Pennsylvania, 19446, United States|Capital Area Research LLC, Newport, Pennsylvania, 17074, United States|Endocrine Metabolic Associates, Philadelphia, Pennsylvania, 19114, United States|Pottstown Medical Specialists, Inc. (PMSI), Pottstown, Pennsylvania, 19464, United States|Geisinger Clinic, Scranton, Pennsylvania, 18508, United States|Partners in Clinical Research, Cumberland, Rhode Island, 02864, United States|Radiant Research, Inc., Greer, South Carolina, 29650, United States|Mountain View Clinical Research, Greer, South Carolina, 29651, United States|Palmetto Research Center, LLC, Spartanburg, South Carolina, 29302, United States|Brown Clinic, PLLP, Watertown, South Dakota, 57201, United States|PMG Research of Bristol, LLC, Bristol, Tennessee, 37620, United States|Chattanooga Research and Medicine (CHARM), Chattanooga, Tennessee, 37404, United States|WR-ClinSearch, LLC, Chattanooga, Tennessee, 37421, United States|Wellmont CVA Heart Institute, Greeneville, Tennessee, 37745-5810, United States|Research Associates of Jackson, Jackson, Tennessee, 38301-3930, United States|Kore Cardiovascular Research, Jackson, Tennessee, 38305, United States|The Jackson Clinic, PA, Jackson, Tennessee, 38305, United States|Wellmont CVA Heart Institute, Johnson City, Tennessee, 37604, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Wellmont CVA Heart Institute, Kingsport, Tennessee, 37660, United States|The Endocrine Clinic, Memphis, Tennessee, 38119, United States|Cardiology Wellness Center, Nashville, Tennessee, 37203, United States|Central Texas Clinical Research, LLC, Austin, Texas, 78705, United States|Texas Diabetes & Endocrinology, Austin, Texas, 78731, United States|Texas Health Physicians Group, Carrollton, Texas, 75007, United States|Adriana Pop-Moody MD Clinic, PA, Corpus Christi, Texas, 78404, United States|Baylor Research Institute, Dallas, Texas, 75024, United States|Texas Health Physicians Group, Dallas, Texas, 75218, United States|Texas Health Physicians Group, Dallas, Dallas, Texas, 75220, United States|Research Institute of Dallas, Dallas, Texas, 75231, United States|Odilon Alvarado, M.D., Fort Worth, Texas, 76104, United States|Texas Health Physicians Group Fort Worth, Fort Worth, Texas, 76107, United States|Tand R Clinic, PA, Fort Worth, Texas, 76117, United States|San Gabriel Clinical Research, LLC, Georgetown, Texas, 78626, United States|Angiocardiac Care of Texas PA, Houston, Texas, 77025 5253, United States|Oxford Clinical Research, LLC, Houston, Texas, 77074, United States|West Houston Area Clinical Trial Consultants, LLC, Houston, Texas, 77094, United States|Endocrine and Psychiatry Center, Houston, Texas, 77095, United States|Texas Health Physicians Group, Irving, Texas, 75039, United States|Texas Cardiology Associates of Houston, Kingwood, Texas, 77339, United States|Jalil Aziz Khan M.D., P.A., Lewisville, Texas, 75067, United States|Midland Clinical Research Center, Midland, Texas, 79707, United States|Permian Research Foundation, Odessa, Texas, 79761, United States|Medical Clinic of North Texas, Plano, Texas, 75023, United States|Clinical Investigations of Texas, LLC, Plano, Texas, 75075, United States|Texas Diabetes, Round Rock, Texas, 78681, United States|Physician PrimeCare Research Institute, PLLC, San Antonio, Texas, 78228, United States|Cardiology Clinic of San Antonio, San Antonio, Texas, 78229, United States|Radiant Research San Antonio, San Antonio, Texas, 78229, United States|Martin Diagnostic Clinic, Tomball, Texas, 77375, United States|Cardiovascular Associates of East Texas, Tyler, Texas, 75701, United States|Bay Area Total Health Medical Group, Webster, Texas, 77598, United States|Advanced Research Institute, Ogden, Utah, 84405, United States|Jean Brown Research, Salt Lake City, Utah, 84124, United States|Alexandria Clinical Research, LLC, Alexandria, Virginia, 22304, United States|Washington Center for Weight Management and Resear, Arlington, Virginia, 22201, United States|Burke Internal Medicine and Research, Burke, Virginia, 22015, United States|Cardiology Consultants of Danville, Inc., Danville, Virginia, 24541, United States|Danville Internal Medicine, Inc, Danville, Virginia, 24541, United States|Virginia Heart, Falls Church, Virginia, 22042-1262, United States|Seven Corners Medical Research Center, Falls Church, Virginia, 22044, United States|INOVA Health Care Services, Manassas, Virginia, 20109, United States|Burke Internal Medicine and Research, Manassas, Virginia, 20110, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Health Research of Hampton Roads - Norfolk, Inc., Norfolk, Virginia, 23502, United States|Clinical Research Associates of Tidewater, Norfolk, Virginia, 23507, United States|Clinical Research Partners, Richmond, Virginia, 23220, United States|Virginia Cardiovascular Specialists, Richmond, Virginia, 23229, United States|National Clinical Research-Richmond, Inc, Richmond, Virginia, 23294, United States|Selma Medical Associates, Winchester, Virginia, 22601, United States|Larry D. Stonesifer, MD, Inc PS, Federal Way, Washington, 98003, United States|Seattle Women's, Seattle, Washington, 98105, United States|Rowan Research Inc., Spokane, Washington, 99218, United States|MultiCare Research Institute, Tacoma, Washington, 98405, United States|Universal Research Group, Tacoma, Washington, 98405, United States|Wenatchee Valley Hospital & Clinics, Wenatchee, Washington, 98801, United States|Cardiology Associates of Bellin Health, Green Bay, Wisconsin, 54301, United States|Prevea Clinic, Inc, Green Bay, Wisconsin, 54303, United States|Clinical Investigation Specialists, Inc., Kenosha, Wisconsin, 53142, United States|Meriter hospital Inc., DBA: UnityPoint Health-Meriter Heart, Madison, Wisconsin, 53713, United States|Marshfield Clinic, Marshfield, Wisconsin, 54449, United States|Aspirus Research Institute, Wausau, Wisconsin, 54401, United States|Coffs Harbour Health Campus, Coffs Harbour, New South Wales, 2450, Australia|Gosford Hospital, Cardiology Clinical Trials, Gosford, New South Wales, 2250, Australia|Liverpool Hospital, Liverpool, New South Wales, 2170, Australia|Illawarra Shoalhaven Local Health District, Clinical Trial and Research Unit, Wollongong, New South Wales, 2500, Australia|Wollongong Hospital, Wollongong, New South Wales, 2500, Australia|Core Research Group, Brisbane, Queensland, 4064, Australia|Princess Alexandra Hospital, Cardiology Research Department, Brisbane, Queensland, 4102, Australia|Royal Brisbane and Women's Hospital, Endocrinology Department, Herston, Queensland, 4029, Australia|HeartCare Partners Clinical Research Unit, Milton, Queensland, 4064, Australia|AusTrials Pty Ltd, Sherwood, Queensland, 4075, Australia|Gold Coast Hospital, Cardiovascular Research Centre, Southport, Queensland, 4215, Australia|New Royal Adelaide Hospital, Cardiology Department, Adelaide, South Australia, 5000, Australia|Adelaide Medical Research, Ashford, South Australia, 5035, Australia|Lyell McEwin Hospital, Department of Cardiology, Elizabeth Vale, South Australia, 5112, Australia|Heart and Vascular Institute, Fullarton, South Australia, SA 5063, Australia|The Queen Elizabeth Hospital, Woodville South, South Australia, 5011, Australia|Ballarat Health Services, Ballarat, Victoria, 3353, Australia|Geelong Cardiology Research Unit, Barwon Health, Geelong, Victoria, 3220, Australia|Austin Health - Heidelberg Repatriation Hospital, Department of Medicine, Boronia Centre, Heidelberg Heights, Victoria, 3081, Australia|Avenue Cardiovascular Centre, Saint Kilda East, Victoria, 3183, Australia|Joondalup Cardiovascular Trials Foundation Inc, Joondalup, Western Australia, 6027, Australia|Fiona Stanley Hospital, Cardiology Research Department,CDO11, Murdoch, Western Australia, 6150, Australia|South Australian Medical Research Inst, Centre for Clinical Research, Adelaide, 5000, Australia|The Partners Clinical Research Centre, Nassau, Bahamas|LMC Clinical Research Inc. (Calgary), Calgary, Alberta, T2H 2G4, Canada|Gordon and Leslie Diamond Health Care Centre, Vancouver, British Columbia, V5Z 1M9, Canada|Nova Scotia Health Authority /QEII Health Sciences Centre, Halifax, Nova Scotia, B3H 3A7, Canada|LMC Diabetes & Endocrinology - Brampton, Brampton, Ontario, L6S0C9, Canada|McMaster University, Brampton, Ontario, L6Z 4N5, Canada|JBN Medical Diagnostic Services Inc., Burlington, Ontario, L7M 4Y1, Canada|Aviva Clinical Trial Group In., Burlington, Ontario, L7R 1E2, Canada|Cambridge Cardiac Care Centre, Cambridge, Ontario, N1R 6V6, Canada|Joanne F. Liutkus Medicine Professional Corp., Cambridge, Ontario, N1R 7L6, Canada|Saul Vizel Professional Medicine Corporation, Vizel Cardiac Research, Cambridge, Ontario, N1R 7R1, Canada|LMC Diabetes & Endocrinology (Etobicoke), Etobicoke, Ontario, M9R4E1, Canada|Wharton Medical Clinic Clinical Trials Group Inc., Hamilton, Ontario, L8L 5G8, Canada|Saint Josephs Health Care London, London, Ontario, N6A 4V2, Canada|LMC Diabetes & Endocrinoly, Markham, Ontario, L6B0P9, Canada|New Market Cardiology Research Group, Newmarket, Ontario, L3Y 8C3, Canada|Dr. Michael Heffernan, Oakville, Ontario, L6K 3W7, Canada|LMC Clinical Research Inc. (Oakville), Oakville, Ontario, L6M 4H8, Canada|Dr. Cha, Oshawa, Ontario, L1J 2K1, Canada|University of Ottawa Heart Institute, Ottawa, Ontario, K1Y 4W7, Canada|Kawartha Cardiology Clinical Trials, Peterborough, Ontario, K9J 0B2, Canada|Dr. Dinkar Shukla Professional Medicine Corporation, Sudbury, Ontario, P3E 6C3, Canada|Dr Roger Labonte Professional Medicine Corp, Sudbury, Ontario, P3E3B8, Canada|LMC Diabetes & Endocrinology (Thornhill), Thornhill, Ontario, L4J8L7, Canada|JJ DIG Research Ltd., Toronto, Ontario, M3J 1N2, Canada|Keele Medical Place, Toronto, Ontario, M3M 3E5, Canada|LMC Clinical Research Inc. (Bayview), Toronto, Ontario, M4G 3E8, Canada|St Michael's Hospital Health Centre, Toronto, Ontario, M5C 2T2, Canada|ViaCar Recherche Clinique, Brossard, Quebec, J4X 1S4, Canada|Q&T Research Outaouais Inc., Gatineau, Quebec, J8Y 6S8, Canada|ViaCar Recherche Clinique Inc., Greenfield Park, Quebec, J4V 2G8, Canada|Manna Research Inc, Levis, Quebec, G6W 0M6, Canada|Clinique Sante Cardio MC, Montreal, Quebec, H1T 3Y7, Canada|Universitaire de Cardiologie et de Pneumologie de Quebec, Quebec City, Quebec, G1V 4G5, Canada|Centre hospitalier régional de Lanaudière, Saint-Charles-Borromee, Quebec, J6E 6J2, Canada|Recherche Clinique London, Sherbrooke, Quebec, J1J 2E3, Canada|CardioVasc HR, Inc., St Jean sur Richelieu, Quebec, J3A1C3, Canada|ViaCar Recherche Clinique Inc., St-Lambert, Quebec, J4P 2H4, Canada|LMC Clinical Research Inc. (Montreal), Ville Saint-Laurent, Quebec, H4T 1Z9, Canada|Biomedica Research Group, Providencia, Santiago, 7500710, Chile|Sociedad Medica Cardiologica El Llano, San Miguel, Santiago, 8910259, Chile|Hospital Regional Concepcion, Concepcion, 4070038, Chile|Cardiocob, Santiago, 7500520, Chile|Servicios Medicos Godoy Ltda., Santiago, 7500710, Chile|Ccbr Cecim, Santiago, 8331143, Chile|Centro Investigacion Clinica del Sur, Temuco, 4781156, Chile|CECMI Ltda., Temuco, 4813299, Chile|ICLE, Guadalajara, Jalisco, 44600, Mexico|Private Medical Practice, Guadalajara, Jalisco, 44657, Mexico|IMED Clin Trials, Monterrey, Nuevo Leon, 64020, Mexico|Cardiolink ClinTrials S.C., Monterrey, Nuevo Leon, 64060, Mexico|Centro de Estudios Clinicos y Especialidades Medicas S.C., Monterrey, Nuevo Leon, 64620, Mexico|Hospital de Angeles Xalapa, Xalapa, Veracruz, 91193, Mexico|Fundacion Cardiovascular de Aguascalientes, Aguascalientes, 20230, Mexico|Hospital Cardiologica Aguascalientes, Aguascalientes, 20230, Mexico|Mentrials S.A.de C.V., Distrito Federal, 06700, Mexico|North Shore Hospital-Cardiology Research, Milford, Auckland, 0622, New Zealand|Middlemore Hospital, Papatoetoe, Auckland, 2025, New Zealand|North Shore Hospital - Diabetes Clinic, Takapuna, Auckland, 0740, New Zealand|Christchurch Hospital, Lipids, Christchurch, Canterbury, 8011, New Zealand|Christchurch Hospital, Cardiology Research, Christchurch, Canterbury, 8811, New Zealand|Dunedin Hospital, Dunedin, Otago, 9016, New Zealand|Taranaki Base Hospital, New Plymouth, Taranaki, 4310, New Zealand|Hutt Hospital, Cardiology Dept, Lower Hutt, Wellington, 5010, New Zealand|Auckland City Hospital, Auckland, 1148, New Zealand|Hawkes Bay Regional Hospital, Hastings, 4120, New Zealand|Nelson Hospital, Cardiology Department, Nelson, 7010, New Zealand|Lakeland Clinical Trials, Rotorua, Rotorua, 3010, New Zealand|Tauranga Hospital, Tauranga, 3112, New Zealand|Indywidualna Specjalistyczna Praktyka Lekarska, Bezrzecze, 72-003, Poland|NZOZ "Eskulap", Biala Rawska, 96-230, Poland|Podlaski Osrodek Kardiologii Janusz Korecki, Białystok, 15-875, Poland|Centrum Medyczne KERmed, Bydgoszcz, 85-231, Poland|10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ, Bydgoszcz, 85-681, Poland|Nzoz "Mada-Med", Chorzów, 41-500, Poland|DIABET Centrum Medyczne s. c., Chrzanów, 32-500, Poland|ISPL w Dziedzinie Kardiologii lek.med. Krzysztof Cymerman, Gdynia, 81-157, Poland|NZOZ SCBK ProCordis, Gdynia, 81-423, Poland|Gabinet Kardiologiczno-Internistyczny, Gdynia, 81-472, Poland|Praktyka Lekarska dr n. med. Marek Bronisz, Inowroclaw, 88-100, Poland|Piotr Mader Diabetic Clinic NZOZ PD-I, Kamieniec Ząbkowicki, 57-230, Poland|NZOZ Eskulap SC, Koluszki, 95-040, Poland|Ewa Mirek-Bryniarska Specjalistyczna Praktyka Lekarska, Kraków, 30-082, Poland|LANDA' Specjalistyczne Gabinety Lekarskie, Kraków, 31-156, Poland|Medyczne Centrum Diabetologiczno Endokrynologiczno, Kraków, 31-261, Poland|Nzoz Cardiamed, Legnica, 59-220, Poland|"CenterMed Lublin" Sp. z o.o., Lublin, 20-044, Poland|Indywidualna Praktyka Lekarska, Mrągowo, 11-700, Poland|Zechowicz MEDEUSZ-PLUS, Olsztyn, 10-010, Poland|Praktyka Lekarska Ewa Krzyzagorska, Poznań, 61-655, Poland|NZOZ NEURO-KARD "Ilkowski i Partnerzy", Poznań, 61-853, Poland|Specjalistyczna Przychodnia Lekarska MEDIKARD (SPL Medikard), Płock, 09-402, Poland|Specjalistyczny Gabinet Lekarski, Tarnów, 33-100, Poland|Lecznice Citomed Sp. z o.o., Toruń, 87-100, Poland|Praktyka Lekarska Pawlowicz Lidia, Toruń, 87-100, Poland|Centrum Medyczne AMED, Warszawa, 01-518, Poland|Centrum Badawcze Wspolczesnej Terapii, Warszawa, 02-679, Poland|SNZOZ Fundacji PROCLINICA, Warszawa, 03-973, Poland|Centrum Zdrowia Wierzchoslawice, Wierzchosławice, 33-122, Poland|Regionalna Poradnia Diabetologiczna, Wroclaw, 50-127, Poland|Specjalistyczne Gabinety Lekarskie "Medicor PLUS", Włocławek, 87-800, Poland|NZOZ ALL-MED Centrum Medyczne, Łódź, 94-048, Poland|SP ZOZ w Lecznej, Łęczna, 21-010, Poland
URL: https://clinicaltrials.gov/show/NCT02019264