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
NCT ID: NCT02019264
Last Updated: 2019-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
14673 participants
INTERVENTIONAL
2014-01-24
2018-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lorcaserin hydrochloride (HCL)10 mg
APD356 10 mg twice daily
Lorcaserin hydrochloride
APD356 10 mg twice daily
Placebo
Placebo twice daily
Placebo
Placebo twice daily
Interventions
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Lorcaserin hydrochloride
APD356 10 mg twice daily
Placebo
Placebo twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
ALL
No
Sponsors
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The TIMI Study Group
OTHER
Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Advanced Cardiovascular, LLC
Alexander City, Alabama, United States
North Alabama Research Center, LLC
Athens, Alabama, United States
UAB Medical Center
Birmingham, Alabama, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Mobile Heart Specialists, PC
Mobile, Alabama, United States
Alaska Heart Institute
Anchorage, Alaska, United States
Connect Clinical Research Center, LCC
Chandler, Arizona, United States
Arrowhead Health Centers
Glendale, Arizona, United States
Phoenix Heart, PLLC
Glendale, Arizona, United States
Eclipse Clinical Research
Tucson, Arizona, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 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
Clinical Research Alliance
Alhambra, California, United States
Central Cardiology
Bakersfield, California, United States
Cardiovascular Research Foundation of Southern Cal
Beverly Hills, California, United States
Capitol Interventional Cardiology
Carmichael, California, United States
San Diego Costal Endocrinology Group AMC
Chula Vista, California, United States
John Muir Physician Network Clinical Research Cent
Concord, California, United States
Medical Group of Encino
Encino, California, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States
California Heart Specialists
Huntington Beach, California, United States
Del Rosario Medical Clinic, Inc.
Huntington Park, California, 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
Torrance Clinical Research Institute, Inc.
Lomita, California, United States
Long Beach Center for Clinical Research
Long Beach, California, United States
Metabolic Clinic and Research Center
Los Angeles, California, United States
Beverly Hills Cardiology
Los Angeles, California, United States
VA Greater Los Angeles Health Care System
Los Angeles, California, United States
Clinical Interventions Research Institute
Mission Viejo, California, United States
Brigid Freyne MD Inc
Murrieta, California, United States
Valley Clinical Trials Inc
Northridge, California, United States
Carr Cardiology
Oceanside, California, United States
Northern California Clinical Research Center
Redding, California, United States
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, United States
University of California San Diego
San Diego, California, United States
Ritchken and First MD's
San Diego, California, United States
West Coast Research LLC
San Ramon, California, United States
Coastal Multi-Specialty Research
Santa Ana, California, United States
Westlake Medical Research
Thousand Oaks, California, United States
Harbor - UCLA Medical Center
Torrance, California, United States
Ronald Chochinov, MD
Ventura, California, United States
Ventura Cardiology Consultants
Ventura, California, United States
Infosphere Clinical Research
West Hills, California, United States
UCH-MHS Cardiac Research
Colorado Springs, Colorado, United States
Creekside Endocrine Associates PC
Denver, Colorado, United States
New West Physicians, PC
Golden, Colorado, United States
University of Colorado Health
Loveland, Colorado, United States
Connecticut Clinical Research, LLC
Bridgeport, Connecticut, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Clinical Research Works, Bristol
Bristol, Connecticut, United States
Cardiology Associates of Fairfield County, Norwalk
Norwalk, Connecticut, United States
Cardiology Associates of Fairfield County, P.C.
Stamford, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Cardiology Associates of Fairfield County, P.C.
Trumbull, Connecticut, United States
Connecticut Heart and Vascular Center
Trumbull, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Red Clay Research
Newark, Delaware, United States
Alfieri Cardiology
Wilmington, Delaware, United States
Aventura Heart Center
Aventura, Florida, 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
Meridien Research, Brooksville
Brooksville, Florida, United States
Clearwater Cardiovascular and Interventional Cons.
Clearwater, Florida, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Holy Cross Medical Group
Coral Springs, Florida, United States
Cardiology Research Associates
Daytona Beach, Florida, United States
International Medical Research
Daytona Beach, Florida, United States
Asclepius Medical Research
Doral, Florida, 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
Florida Research Network, LLC
Gainesville, Florida, United States
George E. Platt, M.D.
Green Cove Springs, Florida, United States
Eastern Research, Inc.
Hialeah, Florida, United States
Larry K. Levinson, D.O., P.A.
Hollywood, Florida, United States
Research Physicians Network Alliance
Hollywood, Florida, United States
Pasco Cardiology Center
Hudson, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
University of Florida- Jacksonville
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Meridien Research
Lakeland, Florida, United States
Pharmax Research Clinic, Inc
Miami, Florida, United States
Life Spring Research Foundation
Miami, Florida, United States
United Clinical Research Corp.
Miami, Florida, United States
Cardiovascular Research Center of South Florida
Miami, Florida, United States
South Florida Research Group LLC
Miami, Florida, United States
South Florida Research Solutions
Miramar, Florida, United States
Southwest Florida Research
Naples, Florida, United States
Ocala Research Institute, Inc
Ocala, Florida, United States
Oviedo Medical Research
Oviedo, Florida, 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
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
Charlotte Heart Group Research Center
Port Charlotte, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Brevard Cardiovascular Research Associates Inc
Rockledge, Florida, United States
Clearwater Cardiovascular and Interventional Cons.
Safety Harbor, Florida, United States
Intercoastal Medical Group
Sarasota, Florida, United States
Springfield Medical Center
Springfield, Florida, United States
Bayfront Health St. Petersburg, Research
St. Petersburg, Florida, United States
Meridien Research - St. Petersburg
St. Petersburg, Florida, United States
Professional Health Care of Pinellas, INC
St. Petersburg, Florida, United States
Advanced Clinical Research Group
Stuart, Florida, United States
Meridien Research - Tampa
Tampa, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Healthpoint Medical Group, Inc
Tampa, Florida, United States
Interventional Cardiac Consultants
Trinity, Florida, United States
Lovelace Scientific Research
Venice, Florida, United States
Indian River Medical Center-Cardiology
Vero Beach, Florida, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States
Cleveland Clinic Foundation
West Palm Beach, Florida, United States
Metabolic Research Institute
West Palm Beach, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Atlanta Diabetes Associates, Endocrinology
Atlanta, Georgia, United States
Rockdale Medical-Research Associates
Conyers, Georgia, United States
Atlanta Heart Specialists
Cumming, Georgia, United States
Urban Family Practice Associates/Clinical Research Advantage
Marietta, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Herman Clinical Research LLC
Suwanee, Georgia, United States
Atlanta Heart Specialists
Tucker, Georgia, United States
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, 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
Consultants in Cardiovascular Medicine
Elmhurst, Illinois, United States
Clinical Investigation Specialists, Inc. in Gurnee
Gurnee, Illinois, United States
Advanced CardioVascular Consultants, SC
Rock Island, Illinois, United States
Community Clinical Research Center
Anderson, Indiana, United States
American Health Network of IN, LLC, Avon
Avon, Indiana, United States
Premier Healthcare, LLC
Bloomington, Indiana, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
American Health Network of IN, LLC, Franklin
Franklin, Indiana, United States
American Health Network of IN, LLC, Greenfield
Greenfield, Indiana, United States
American Health Network - Thomas Moretto, MD
Indianapolis, Indiana, United States
Medical Consultants PC
Muncie, Indiana, United States
American Health Network of IN, LLC
Muncie, Indiana, United States
Cardiology Associates of Northwest Indiana, P.C
Munster, Indiana, United States
The University of Iowa, College of Public Health
Iowa City, Iowa, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States
Norton Heart Specialists
Louisville, Kentucky, United States
Norton Heart Specialists
Louisville, Kentucky, United States
L-MARC Research Center
Louisville, Kentucky, United States
Research Integrity LLC
Owensboro, Kentucky, United States
Central Maine Medical Center
Auburn, Maine, United States
Acadia Clinical Research, LLC
Bangor, Maine, United States
Eastern Maine Medical Center Northeast Cardiology Associates
Bangor, Maine, United States
Southern Maine Health Care/Maine Medical Center Research Ins
Biddeford, Maine, United States
InterMed, PA
Portland, Maine, United States
Medstar Cardiology Associates
Annapolis, Maryland, 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
Spectrum Clinical Research
Baltimore, Maryland, United States
Overlea Personal Physicians
Baltimore, Maryland, United States
Shahid Saeed MD, PC
Baltimore, Maryland, United States
Maryland Heart Associates, LLC
Glen Burnie, Maryland, United States
Klein & Associates, MD, PA
Hagerstown, Maryland, United States
MedStar Health Research Institute
Hyattsville, Maryland, United States
Lutherville Personal Physicians
Lutherville, Maryland, United States
MD Medical Research
Oxon Hill, Maryland, United States
Endocrine & Metabolic Consultants
Rockville, Maryland, United States
Lutherville Personal Physicians
Towson, Maryland, United States
Overlea Personal Physicians
Towson, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
MGH Weight Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
New England Center for Clinical Research, IMCA
Fall River, Massachusetts, United States
Pentucket Medical Associates
Haverhill, Massachusetts, United States
ActivMed Practices
Methuen, Massachusetts, United States
Partners Community Physicians Organization
Natick, Massachusetts, United States
Partners Community Physicians Organization
Needham, Massachusetts, United States
Endeavor Medical Research PLC
Alpena, Michigan, United States
Cadillac Clinical Research, LLC
Cadillac, Michigan, United States
Westside Family Medical Center, PC
Kalamazoo, Michigan, United States
Cardiology Consultants of East Michigan
Lapeer, Michigan, United States
Marquette General Heart and Vascular Institute
Marquette, Michigan, United States
MidMichigan Medical Center
Midland, Michigan, United States
Nisus Research at McLaren Northern Michigan Hospital
Petoskey, Michigan, United States
Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Remedica LLC
Rochester, Michigan, United States
Michigan CardioVascular Institute
Saginaw, Michigan, United States
American Center for Clinical Trials
Southfield, Michigan, United States
Medical Research Associates, Inc.
Traverse City, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Minneapolis Heart Institute Foundation
Baxter, Minnesota, United States
Essentia Institute of Rural Health
Duluth, Minnesota, United States
MNCOME Clinic
Eagan, Minnesota, United States
Radiant Research, Inc.
Edina, Minnesota, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Coast Cardiovascular Consultants PLLC
Gulfport, Mississippi, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
Diabetes & Endocrinology Specialists, Inc.
Chesterfield, Missouri, United States
BodyAesthetic Research Center
Washington, Missouri, United States
Billings Clinic Research Center
Billings, Montana, United States
Montana Health Research Institute, Inc.
Billings, Montana, United States
Glacier View Cardiology PC
Kalispell, Montana, United States
Internal Medical Associates of Grand Island, PC
Grand Island, Nebraska, United States
Clinical Research Advantage / Rita Chuang, M.D.
Henderson, Nevada, United States
Clinical Research Advantage, Inc.
Las Vegas, Nevada, United States
Clinical Research of South Nevada
Las Vegas, Nevada, United States
Medicor Cardiology, PA
Bridgewater, New Jersey, United States
Advanced Heart Care
Bridgewater, New Jersey, United States
UmiMed Center LLC
East Brunswick, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, 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
NJ Heart
Linden, New Jersey, United States
Rutgers New Jersey Medical School
Mine Hill, New Jersey, United States
Cardiovascular Associates Delaware Valley Sewell
Sewell, New Jersey, United States
Cardio Metabolic Institute
Somerset, New Jersey, United States
New Mexico Heart Institute, PA
Albuquerque, New Mexico, United States
Albany College of Medicine, Division of Endocrinology
Albany, New York, United States
Capital Cardiology Associates
Albany, New York, United States
United Medical Associates, PC
Binghamton, New York, United States
Buffalo Heart Group
Buffalo, New York, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, United States
Long Island Heart Associates
Mineola, New York, 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
DiGiovanna Institute for Medical Education
North Massapequa, New York, United States
Hudson Valley Heart Center
Poughkeepsie, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Northwell Health Physician Partners Cardiology
Southampton, New York, United States
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States
Capital Cardiology Associates
Troy, New York, United States
Great Lakes Medical Research
Westfield, New York, United States
Kernodle Clinic
Burlington, North Carolina, United States
Clinical Trials of America Inc.
Cary, North Carolina, United States
Metrolina Internal Medicine
Charlotte, North Carolina, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
Bland Clinic, PA
Greensboro, North Carolina, 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
Clinical Trials of America, Inc.
Lenoir, North Carolina, United States
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, United States
Burke Primary Care
Morganton, North Carolina, United States
Pinehurst Medical Clinic, Inc.
Pinehurst, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
PMG Research of Rocky Mount
Rocky Mount, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Sanford Cardiology
Sanford, North Carolina, United States
Piedmont Healthcare
Statesville, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Aultman Hospital
Canton, Ohio, United States
The Lindner Research Center
Cincinnati, Ohio, United States
Sentral Clinical Research
Cincinnati, Ohio, United States
Delaware Research Group, LLC
Delaware, Ohio, United States
Awasty Research Network, LLC
Marion, Ohio, United States
Community Health Care
Massillon, Ohio, United States
Apex Medical Research Inc.
Springfield, Ohio, 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
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Vital Prospects Clinical Research Institute PC
Tulsa, Oklahoma, United States
Blair Medical Associates
Altoona, Pennsylvania, United States
Clinical Research Associates of Central PA, LLC
Altoona, Pennsylvania, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
Geisinger Health Clinic
Danville, Pennsylvania, United States
Geisinger Health System
Danville, Pennsylvania, United States
Doylestown Health Cardiology a Division of Doylestown Health
Doylestown, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Liberty Family Practice
Erie, Pennsylvania, United States
Endocrine Clinical Research LLC
Feasterville, Pennsylvania, United States
Joseph Lamantia, DO
Indiana, Pennsylvania, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Lycoming Internal Medicine, Inc.
Jersey Shore, Pennsylvania, United States
Berkley Hills Clinicals
Johnstown, Pennsylvania, United States
Ilumina Clinical Associates, Johnstown
Johnstown, Pennsylvania, United States
Joseph Lamantia, DO
Johnstown, Pennsylvania, 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
Capital Area Research LLC
Newport, Pennsylvania, United States
Endocrine Metabolic Associates
Philadelphia, Pennsylvania, United States
Pottstown Medical Specialists, Inc. (PMSI)
Pottstown, Pennsylvania, United States
Geisinger Clinic
Scranton, Pennsylvania, United States
Partners in Clinical Research
Cumberland, Rhode Island, United States
Radiant Research, Inc.
Greer, South Carolina, United States
Mountain View Clinical Research
Greer, South Carolina, United States
Palmetto Research Center, LLC
Spartanburg, South Carolina, United States
Brown Clinic, PLLP
Watertown, South Dakota, United States
PMG Research of Bristol, LLC
Bristol, Tennessee, United States
Chattanooga Research and Medicine (CHARM)
Chattanooga, Tennessee, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States
Wellmont CVA Heart Institute
Greeneville, Tennessee, United States
Research Associates of Jackson
Jackson, Tennessee, United States
Kore Cardiovascular Research
Jackson, Tennessee, United States
The Jackson Clinic, PA
Jackson, Tennessee, United States
Wellmont CVA Heart Institute
Johnson City, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
The Endocrine Clinic
Memphis, Tennessee, United States
Cardiology Wellness Center
Nashville, Tennessee, United States
Central Texas Clinical Research, LLC
Austin, Texas, United States
Texas Diabetes & Endocrinology
Austin, Texas, United States
Texas Health Physicians Group
Carrollton, Texas, United States
Adriana Pop-Moody MD Clinic, PA
Corpus Christi, Texas, United States
Baylor Research Institute
Dallas, Texas, United States
Texas Health Physicians Group
Dallas, Texas, United States
Texas Health Physicians Group, Dallas
Dallas, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
Odilon Alvarado, M.D.
Fort Worth, Texas, United States
Texas Health Physicians Group Fort Worth
Fort Worth, Texas, United States
Tand R Clinic, PA
Fort Worth, Texas, United States
San Gabriel Clinical Research, LLC
Georgetown, Texas, United States
Angiocardiac Care of Texas PA
Houston, Texas, United States
Oxford Clinical Research, LLC
Houston, Texas, United States
West Houston Area Clinical Trial Consultants, LLC
Houston, Texas, United States
Endocrine and Psychiatry Center
Houston, Texas, United States
Texas Health Physicians Group
Irving, Texas, United States
Texas Cardiology Associates of Houston
Kingwood, Texas, United States
Jalil Aziz Khan M.D., P.A.
Lewisville, Texas, United States
Midland Clinical Research Center
Midland, Texas, United States
Permian Research Foundation
Odessa, Texas, United States
Medical Clinic of North Texas
Plano, Texas, United States
Clinical Investigations of Texas, LLC
Plano, Texas, United States
Texas Diabetes
Round Rock, Texas, United States
Physician PrimeCare Research Institute, PLLC
San Antonio, Texas, United States
Cardiology Clinic of San Antonio
San Antonio, Texas, United States
Radiant Research San Antonio
San Antonio, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
Cardiovascular Associates of East Texas
Tyler, Texas, United States
Bay Area Total Health Medical Group
Webster, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Jean Brown Research
Salt Lake City, Utah, United States
Alexandria Clinical Research, LLC
Alexandria, Virginia, United States
Washington Center for Weight Management and Resear
Arlington, Virginia, United States
Burke Internal Medicine and Research
Burke, Virginia, United States
Cardiology Consultants of Danville, Inc.
Danville, Virginia, United States
Danville Internal Medicine, Inc
Danville, Virginia, United States
Virginia Heart
Falls Church, Virginia, United States
Seven Corners Medical Research Center
Falls Church, Virginia, United States
INOVA Health Care Services
Manassas, Virginia, United States
Burke Internal Medicine and Research
Manassas, Virginia, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Health Research of Hampton Roads - Norfolk, Inc.
Norfolk, Virginia, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Clinical Research Partners
Richmond, Virginia, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, United States
National Clinical Research-Richmond, Inc
Richmond, Virginia, United States
Selma Medical Associates
Winchester, Virginia, United States
Larry D. Stonesifer, MD, Inc PS
Federal Way, Washington, United States
Seattle Women's
Seattle, Washington, United States
Rowan Research Inc.
Spokane, Washington, United States
MultiCare Research Institute
Tacoma, Washington, United States
Universal Research Group
Tacoma, Washington, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States
Cardiology Associates of Bellin Health
Green Bay, Wisconsin, United States
Prevea Clinic, Inc
Green Bay, Wisconsin, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States
Meriter hospital Inc., DBA: UnityPoint Health-Meriter Heart
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Aspirus Research Institute
Wausau, Wisconsin, United States
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
Gosford Hospital, Cardiology Clinical Trials
Gosford, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Illawarra Shoalhaven Local Health District, Clinical Trial and Research Unit
Wollongong, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Core Research Group
Brisbane, Queensland, Australia
Princess Alexandra Hospital, Cardiology Research Department
Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital, Endocrinology Department
Herston, Queensland, Australia
HeartCare Partners Clinical Research Unit
Milton, Queensland, Australia
AusTrials Pty Ltd
Sherwood, Queensland, Australia
Gold Coast Hospital, Cardiovascular Research Centre
Southport, Queensland, Australia
New Royal Adelaide Hospital, Cardiology Department
Adelaide, South Australia, Australia
Adelaide Medical Research
Ashford, South Australia, Australia
Lyell McEwin Hospital, Department of Cardiology
Elizabeth Vale, South Australia, Australia
Heart and Vascular Institute
Fullarton, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Ballarat Health Services
Ballarat, Victoria, Australia
Geelong Cardiology Research Unit, Barwon Health
Geelong, Victoria, Australia
Austin Health - Heidelberg Repatriation Hospital, Department of Medicine, Boronia Centre
Heidelberg Heights, Victoria, Australia
Avenue Cardiovascular Centre
Saint Kilda East, Victoria, Australia
Joondalup Cardiovascular Trials Foundation Inc
Joondalup, Western Australia, Australia
Fiona Stanley Hospital, Cardiology Research Department,CDO11
Murdoch, Western Australia, Australia
South Australian Medical Research Inst, Centre for Clinical Research
Adelaide, , Australia
LMC Clinical Research Inc. (Calgary)
Calgary, Alberta, Canada
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
Nova Scotia Health Authority /QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
LMC Diabetes & Endocrinology - Brampton
Brampton, Ontario, Canada
McMaster University
Brampton, Ontario, Canada
JBN Medical Diagnostic Services Inc.
Burlington, Ontario, Canada
Aviva Clinical Trial Group In.
Burlington, Ontario, 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
Dr. Dinkar Shukla Professional Medicine Corporation
Greater Sudbury, Ontario, Canada
Dr Roger Labonte Professional Medicine Corp
Greater Sudbury, Ontario, Canada
Wharton Medical Clinic Clinical Trials Group Inc.
Hamilton, Ontario, Canada
Saint Josephs Health Care London
London, Ontario, Canada
LMC Diabetes & Endocrinoly
Markham, Ontario, Canada
New Market Cardiology Research Group
Newmarket, Ontario, Canada
Dr. Michael Heffernan
Oakville, Ontario, Canada
LMC Clinical Research Inc. (Oakville)
Oakville, Ontario, Canada
Dr. Cha
Oshawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, Canada
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
ViaCar Recherche Clinique
Brossard, Quebec, Canada
Q&T Research Outaouais Inc.
Gatineau, Quebec, Canada
ViaCar Recherche Clinique Inc.
Greenfield Park, Quebec, Canada
Manna Research Inc
Lévis, Quebec, Canada
Clinique Sante Cardio MC
Montreal, Quebec, Canada
Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada
Centre hospitalier régional de Lanaudière
Saint-Charles-Borromée, Quebec, Canada
CardioVasc HR, Inc.
Saint-Jean-sur-Richelieu, Quebec, Canada
ViaCar Recherche Clinique Inc.
Saint-Lambert, Quebec, Canada
LMC Clinical Research Inc. (Montreal)
Saint-Laurent, Quebec, Canada
Recherche Clinique London
Sherbrooke, Quebec, Canada
Biomedica Research Group
Providencia, Santiago Metropolitan, Chile
Sociedad Medica Cardiologica El Llano
San Miguel, Santiago Metropolitan, Chile
Hospital Regional Concepcion
Concepción, , Chile
Cardiocob
Santiago, , Chile
Servicios Medicos Godoy Ltda.
Santiago, , Chile
Ccbr Cecim
Santiago, , Chile
Centro Investigacion Clinica del Sur
Temuco, , Chile
CECMI Ltda.
Temuco, , Chile
ICLE
Guadalajara, Jalisco, Mexico
Private Medical Practice
Guadalajara, Jalisco, Mexico
IMED Clin Trials
Monterrey, Nuevo León, Mexico
Cardiolink ClinTrials S.C.
Monterrey, Nuevo León, Mexico
Centro de Estudios Clinicos y Especialidades Medicas S.C.
Monterrey, Nuevo León, Mexico
Hospital de Angeles Xalapa
Xalapa, Veracruz, Mexico
Fundacion Cardiovascular de Aguascalientes
Aguascalientes, , Mexico
Hospital Cardiologica Aguascalientes
Aguascalientes, , Mexico
Mentrials S.A.de C.V.
Distrito Federal, , Mexico
North Shore Hospital-Cardiology Research
Milford, Auckland, New Zealand
Middlemore Hospital
Papatoetoe, Auckland, New Zealand
North Shore Hospital - Diabetes Clinic
Takapuna, Auckland, New Zealand
Christchurch Hospital, Lipids
Christchurch, Canterbury, New Zealand
Christchurch Hospital, Cardiology Research
Christchurch, Canterbury, New Zealand
Dunedin Hospital
Dunedin, Otago, New Zealand
Taranaki Base Hospital
New Plymouth, Taranaki Region, New Zealand
Hutt Hospital, Cardiology Dept
Lower Hutt, Wellington Region, New Zealand
Auckland City Hospital
Auckland, , New Zealand
Hawkes Bay Regional Hospital
Hastings, , New Zealand
Nelson Hospital, Cardiology Department
Nelson, , New Zealand
Lakeland Clinical Trials, Rotorua
Rotorua, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
Indywidualna Specjalistyczna Praktyka Lekarska
Bezrzecze, , Poland
Podlaski Osrodek Kardiologii Janusz Korecki
Bialystok, , Poland
NZOZ "Eskulap"
Biała Rawska, , Poland
Centrum Medyczne KERmed
Bydgoszcz, , Poland
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
Bydgoszcz, , Poland
Nzoz "Mada-Med"
Chorzów, , Poland
DIABET Centrum Medyczne s. c.
Chrzanów, , Poland
ISPL w Dziedzinie Kardiologii lek.med. Krzysztof Cymerman
Gdynia, , Poland
NZOZ SCBK ProCordis
Gdynia, , Poland
Gabinet Kardiologiczno-Internistyczny
Gdynia, , Poland
Praktyka Lekarska dr n. med. Marek Bronisz
Inowrocław, , Poland
Piotr Mader Diabetic Clinic NZOZ PD-I
Kamieniec Ząbkowicki, , Poland
NZOZ Eskulap SC
Koluszki, , Poland
Ewa Mirek-Bryniarska Specjalistyczna Praktyka Lekarska
Krakow, , Poland
LANDA' Specjalistyczne Gabinety Lekarskie
Krakow, , Poland
Medyczne Centrum Diabetologiczno Endokrynologiczno
Krakow, , Poland
Nzoz Cardiamed
Legnica, , Poland
NZOZ ALL-MED Centrum Medyczne
Lodz, , Poland
"CenterMed Lublin" Sp. z o.o.
Lublin, , Poland
Indywidualna Praktyka Lekarska
Mrągowo, , Poland
Zechowicz MEDEUSZ-PLUS
Olsztyn, , Poland
Praktyka Lekarska Ewa Krzyzagorska
Poznan, , Poland
NZOZ NEURO-KARD "Ilkowski i Partnerzy"
Poznan, , Poland
Specjalistyczna Przychodnia Lekarska MEDIKARD (SPL Medikard)
Płock, , Poland
Specjalistyczny Gabinet Lekarski
Tarnów, , Poland
Lecznice Citomed Sp. z o.o.
Torun, , Poland
Praktyka Lekarska Pawlowicz Lidia
Torun, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
Centrum Badawcze Wspolczesnej Terapii
Warsaw, , Poland
SNZOZ Fundacji PROCLINICA
Warsaw, , Poland
Centrum Zdrowia Wierzchoslawice
Wierzchosławice, , Poland
Regionalna Poradnia Diabetologiczna
Wroclaw, , Poland
Specjalistyczne Gabinety Lekarskie "Medicor PLUS"
Włocławek, , Poland
SP ZOZ w Lecznej
Łęczna, , Poland
The Partners Clinical Research Centre
Nassau, , The Bahamas
Countries
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References
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Scirica BM, Bohula EA, Dwyer JP, Qamar A, Inzucchi SE, McGuire DK, Keech AC, Smith SR, Murphy SA, Im K, Leiter LA, Gupta M, Patel T, Miao W, Perdomo C, Bonaca MP, Ruff CT, Sabatine MS, Wiviott SD; CAMELLIA-TIMI 61 Steering Committee and Investigators. Lorcaserin and Renal Outcomes in Obese and Overweight Patients in the CAMELLIA-TIMI 61 Trial. Circulation. 2019 Jan 15;139(3):366-375. doi: 10.1161/CIRCULATIONAHA.118.038341.
Bohula EA, Scirica BM, Inzucchi SE, McGuire DK, Keech AC, Smith SR, Kanevsky E, Murphy SA, Leiter LA, Dwyer JP, Corbalan R, Hamm C, Kaplan L, Nicolau JC, Ophuis TO, Ray KK, Ruda M, Spinar J, Patel T, Miao W, Perdomo C, Francis B, Dhadda S, Bonaca MP, Ruff CT, Sabatine MS, Wiviott SD; CAMELLIA-TIMI 61 Steering Committee Investigators. Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial. Lancet. 2018 Nov 24;392(10161):2269-2279. doi: 10.1016/S0140-6736(18)32328-6. Epub 2018 Oct 4.
Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, Fanola CL, Qamar A, Brown C, Budaj A, Garcia-Castillo A, Gupta M, Leiter LA, Weissman NJ, White HD, Patel T, Francis B, Miao W, Perdomo C, Dhadda S, Bonaca MP, Ruff CT, Keech AC, Smith SR, Sabatine MS, Scirica BM; CAMELLIA-TIMI 61 Steering Committee and Investigators. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. N Engl J Med. 2018 Sep 20;379(12):1107-1117. doi: 10.1056/NEJMoa1808721. Epub 2018 Aug 26.
Bohula EA, Scirica BM, Fanola C, Inzucchi SE, Keech A, McGuire DK, Smith SR, Abrahamsen T, Francis BH, Miao W, Perdomo CA, Satlin A, Wiviott SD, Sabatine MS. Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial. Am Heart J. 2018 Aug;202:39-48. doi: 10.1016/j.ahj.2018.03.012. Epub 2018 Mar 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-000324-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
APD356-G000-401
Identifier Type: -
Identifier Source: org_study_id
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