AzTrials
AzTrials

Cardiovascular DiseasePhase 4CAMELLIA-TIMINCT02019264

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

A Phase 4 study testing Lorcaserin hydrochloride in people with Cardiovascular Disease and High Cardiovascular Risk, run by Eisai Inc. at 499 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 40 years and older
What is being tested?
Lorcaserin hydrochloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14,673 participants
Where
499 sitesin 8 countries
Study dates
24 Jan 2014to 14 May 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BMI greater than or equal (>=) to 27 kilogram per meter square (kg/m^2)
  • Subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program
  • Age >= to 40 years with established CV disease as defined by one of the following:
  • History of documented MI or ischemic stroke
  • History of peripheral artery disease
  • History of revascularization (coronary, carotid, or peripheral artery)
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  • 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:
  • Hypertension, or currently receiving therapy for documented hypertension
  • Dyslipidemia, or currently taking prescription lipid-lowering therapy for documented dyslipidemia
  • 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
  • High high sensitivity C-reactive protein (hsCRP)
  • 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.

Who cannot join

  • Moderate or greater symptoms of congestive cardiac failure (New York Heart Association [NYHA] class III or IV)
  • Known left ventricular (LV) ejection fraction < than 20%
  • Moderate or greater symptoms of pulmonary hypertension (PH)
  • Known severe valvular disease
  • 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)
  • Severe hepatic impairment
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  • Use of other products intended for weight loss including prescription drugs, over-the-counter (OTC) drugs, and herbal preparations
  • Use of more than one other serotonergic drug
  • 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
  • History or evidence of clinically significant disease (e.g., malignancy, cardiac, respiratory, gastrointestinal, renal or psychiatric disease)
  • Use of lorcaserin HCl prior to Screening or hypersensitivity to lorcaserin HCl or any of the excipients
  • Planned bariatric surgery
  • Females must not be breastfeeding or pregnant

Trial locations and contacts

499 sites in 8 countries.

426 sites in 8 countries

United States300 sites

  • Albany College of Medicine, Division of Endocrinology

    Albany, New York, 12206

  • Capital Cardiology Associates

    Albany, New York, 12211

  • New Mexico Heart Institute, PA

    Albuquerque, New Mexico, 87102

  • Advanced Cardiovascular, LLC

    Alexander City, Alabama, 35010

  • Alexandria Clinical Research, LLC

    Alexandria, Virginia, 22304

  • Clinical Research Alliance

    Alhambra, California, 91801

  • Endeavor Medical Research PLC

    Alpena, Michigan, 49707

  • Blair Medical Associates

    Altoona, Pennsylvania, 16602

  • Clinical Research Associates of Central PA, LLC

    Altoona, Pennsylvania, 16602

  • Alaska Heart Institute

    Anchorage, Alaska, 99508

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Medstar Cardiology Associates

    Annapolis, Maryland, 21401

  • Washington Center for Weight Management and Resear

    Arlington, Virginia, 22201

  • Northwest Heart Clinical Research, LLC

    Arlington Heights, Illinois, 60005

  • North Alabama Research Center, LLC

    Athens, Alabama, 35611

  • Atlanta Diabetes Associates, Endocrinology

    Atlanta, Georgia, 30318

  • Central Maine Medical Center

    Auburn, Maine, 04210

  • Central Texas Clinical Research, LLC

    Austin, Texas, 78705

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78731

  • Aventura Heart Center

    Aventura, Florida, 33180

  • American Health Network of IN, LLC, Avon

    Avon, Indiana, 46123

  • Central Cardiology

    Bakersfield, California, 93308

  • Chesapeake Cardiovascular Associates, GBMC

    Baltimore, Maryland, 21204

  • Clinical Research, Inc

    Baltimore, Maryland, 21204

  • Medstar Union Memorial Heart Specialists

    Baltimore, Maryland, 21218

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Spectrum Clinical Research

    Baltimore, Maryland, 21229

  • Overlea Personal Physicians

    Baltimore, Maryland, 21236

  • Shahid Saeed MD, PC

    Baltimore, Maryland, 21237

  • Acadia Clinical Research, LLC

    Bangor, Maine, 04401

  • Eastern Maine Medical Center Northeast Cardiology Associates

    Bangor, Maine, 04401

  • Minneapolis Heart Institute Foundation

    Baxter, Minnesota, 56425

  • Cardiovascular Research Foundation of Southern Cal

    Beverly Hills, California, 90210

  • Southern Maine Health Care/Maine Medical Center Research Ins

    Biddeford, Maine, 04005

  • Billings Clinic Research Center

    Billings, Montana, 59101

  • Montana Health Research Institute, Inc.

    Billings, Montana, 59102

  • United Medical Associates, PC

    Binghamton, New York, 13901

  • UAB Medical Center

    Birmingham, Alabama, 35294

  • Premier Healthcare, LLC

    Bloomington, Indiana, 47403 3239

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • MGH Weight Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Zasa Clinical Research

    Boynton Beach, Florida, 33427

  • Meridien Research

    Bradenton, Florida, 34201

  • NOVA Southeastern University

    Bradenton, Florida, 34209

  • Bay Area Cardiology

    Brandon, Florida, 33511

  • Connecticut Clinical Research, LLC

    Bridgeport, Connecticut, 06606

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Medicor Cardiology, PA

    Bridgewater, New Jersey, 08807-3060

  • Advanced Heart Care

    Bridgewater, New Jersey, 08807

  • Clinical Research Works, Bristol

    Bristol, Connecticut, 06010-5103

  • PMG Research of Bristol, LLC

    Bristol, Tennessee, 37620

  • Meridien Research, Brooksville

    Brooksville, Florida, 34601

  • Buffalo Heart Group

    Buffalo, New York, 14215

  • Burke Internal Medicine and Research

    Burke, Virginia, 22015

  • Kernodle Clinic

    Burlington, North Carolina, 27215

  • Cadillac Clinical Research, LLC

    Cadillac, Michigan, 49601

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Aultman Hospital

    Canton, Ohio, 44710

  • Capitol Interventional Cardiology

    Carmichael, California, 95608

  • Texas Health Physicians Group

    Carrollton, Texas, 75007

  • Clinical Trials of America Inc.

    Cary, North Carolina, 27518

  • Connect Clinical Research Center, LCC

    Chandler, Arizona, 85224

  • Metrolina Internal Medicine

    Charlotte, North Carolina, 28204

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina, 28209

  • Chattanooga Research and Medicine (CHARM)

    Chattanooga, Tennessee, 37404

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Diabetes & Endocrinology Specialists, Inc.

    Chesterfield, Missouri, 63017

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • San Diego Costal Endocrinology Group AMC

    Chula Vista, California, 91911 3813

  • The Lindner Research Center

    Cincinnati, Ohio, 45219

  • Sentral Clinical Research

    Cincinnati, Ohio, 45236

  • Clearwater Cardiovascular and Interventional Cons.

    Clearwater, Florida, 33756

  • UCH-MHS Cardiac Research

    Colorado Springs, Colorado, 80909

  • John Muir Physician Network Clinical Research Cent

    Concord, California, 94520

  • Rockdale Medical-Research Associates

    Conyers, Georgia, 30094

  • Clinical Research of South Florida

    Coral Gables, Florida, 33143

  • Holy Cross Medical Group

    Coral Springs, Florida, 33065

  • Adriana Pop-Moody MD Clinic, PA

    Corpus Christi, Texas, 78404

  • Partners in Clinical Research

    Cumberland, Rhode Island, 02864

  • Atlanta Heart Specialists

    Cumming, Georgia, 30041

  • Baylor Research Institute

    Dallas, Texas, 75024

  • Texas Health Physicians Group

    Dallas, Texas, 75218

  • Texas Health Physicians Group, Dallas

    Dallas, Texas, 75220

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Geisinger Health Clinic

    Danville, Pennsylvania, 17822

  • Geisinger Health System

    Danville, Pennsylvania, 17822

  • Cardiology Consultants of Danville, Inc.

    Danville, Virginia, 24541

  • Danville Internal Medicine, Inc

    Danville, Virginia, 24541

  • Cardiology Research Associates

    Daytona Beach, Florida, 32117

  • International Medical Research

    Daytona Beach, Florida, 32117

  • Delaware Research Group, LLC

    Delaware, Ohio, 43015

  • Creekside Endocrine Associates PC

    Denver, Colorado, 80209

  • Asclepius Medical Research

    Doral, Florida, 33166

  • Doylestown Health Cardiology a Division of Doylestown Health

    Doylestown, Pennsylvania, 18901

  • Essentia Institute of Rural Health

    Duluth, Minnesota, 55805

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • MNCOME Clinic

    Eagan, Minnesota, 55123

  • UmiMed Center LLC

    East Brunswick, New Jersey, 08816

  • Radiant Research, Inc.

    Edina, Minnesota, 55435

  • Cardiovascular Associates of the Delaware Valley

    Elmer, New Jersey, 08318-1715

  • Consultants in Cardiovascular Medicine

    Elmhurst, Illinois, 60126

  • Medical Group of Encino

    Encino, California, 91436

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Liberty Family Practice

    Erie, Pennsylvania, 16508

  • Deaconess Clinic, Inc.

    Evansville, Indiana, 47713

  • New England Center for Clinical Research, IMCA

    Fall River, Massachusetts, 02720

  • Virginia Heart

    Falls Church, Virginia, 22042-1262

  • Seven Corners Medical Research Center

    Falls Church, Virginia, 22044

  • Lillestol Research LLC

    Fargo, North Dakota, 58103

  • Endocrine Clinical Research LLC

    Feasterville, Pennsylvania, 19053

  • Larry D. Stonesifer, MD, Inc PS

    Federal Way, Washington, 98003

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • Integrative Research Associates, Inc.

    Fort Lauderdale, Florida, 33312

  • M & O Clinical Research, LLC

    Fort Lauderdale, Florida, 33316

  • Primary Care Associates

    Fort Myers, Florida, 33907

  • Odilon Alvarado, M.D.

    Fort Worth, Texas, 76104

  • Texas Health Physicians Group Fort Worth

    Fort Worth, Texas, 76107

  • Tand R Clinic, PA

    Fort Worth, Texas, 76117

  • American Health Network of IN, LLC, Franklin

    Franklin, Indiana, 46131

  • Florida Research Network, LLC

    Gainesville, Florida, 32605

  • San Gabriel Clinical Research, LLC

    Georgetown, Texas, 78626

  • Maryland Heart Associates, LLC

    Glen Burnie, Maryland, 21061

  • Arrowhead Health Centers

    Glendale, Arizona, 85306

  • Phoenix Heart, PLLC

    Glendale, Arizona, 85306

  • New West Physicians, PC

    Golden, Colorado, 80401

  • Internal Medical Associates of Grand Island, PC

    Grand Island, Nebraska, 68803

  • Long Island Gastrointestinal Research Group LLP

    Great Neck, New York, 11023

  • Cardiology Associates of Bellin Health

    Green Bay, Wisconsin, 54301

  • Prevea Clinic, Inc

    Green Bay, Wisconsin, 54303

  • George E. Platt, M.D.

    Green Cove Springs, Florida, 32043

  • Marin Endocrine Care & Research, Inc.

    Greenbrae, California, 94904

  • Wellmont CVA Heart Institute

    Greeneville, Tennessee, 37745-5810

  • American Health Network of IN, LLC, Greenfield

    Greenfield, Indiana, 46140

  • Bland Clinic, PA

    Greensboro, North Carolina, 27401

  • Radiant Research, Inc.

    Greer, South Carolina, 29650

  • Mountain View Clinical Research

    Greer, South Carolina, 29651

  • Coast Cardiovascular Consultants PLLC

    Gulfport, Mississippi, 39501

  • Clinical Investigation Specialists, Inc. in Gurnee

    Gurnee, Illinois, 60031

  • Advocare Heights Primary Care

    Haddon Heights, New Jersey, 08035

  • Cardiovascular Associates of the Delaware Valley P

    Haddon Heights, New Jersey, 08035

  • Klein & Associates, MD, PA

    Hagerstown, Maryland, 21740

  • Pentucket Medical Associates

    Haverhill, Massachusetts, 01830

  • Clinical Research Advantage / Rita Chuang, M.D.

    Henderson, Nevada, 89052

  • Eastern Research, Inc.

    Hialeah, Florida, 33013

  • Clinical Trials of America Inc. Hickory

    Hickory, North Carolina, 28601

  • Clinical Trials of America, Inc.

    Hickory, North Carolina, 28601

  • Peters Medical Research

    High Point, North Carolina, 27262

  • Larry K. Levinson, D.O., P.A.

    Hollywood, Florida, 33021

  • Research Physicians Network Alliance

    Hollywood, Florida, 33021

  • Angiocardiac Care of Texas PA

    Houston, Texas, 77025 5253

  • Oxford Clinical Research, LLC

    Houston, Texas, 77074

  • West Houston Area Clinical Trial Consultants, LLC

    Houston, Texas, 77094

  • Endocrine and Psychiatry Center

    Houston, Texas, 77095

  • Pasco Cardiology Center

    Hudson, Florida, 34667

  • California Heart Specialists

    Huntington Beach, California, 92648

  • Del Rosario Medical Clinic, Inc.

    Huntington Park, California, 90255

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782

  • Joseph Lamantia, DO

    Indiana, Pennsylvania, 15701

  • American Health Network - Thomas Moretto, MD

    Indianapolis, Indiana, 46254-5471

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • The University of Iowa, College of Public Health

    Iowa City, Iowa, 52242

  • Texas Health Physicians Group

    Irving, Texas, 75039

  • Research Associates of Jackson

    Jackson, Tennessee, 38301-3930

  • Kore Cardiovascular Research

    Jackson, Tennessee, 38305

  • The Jackson Clinic, PA

    Jackson, Tennessee, 38305

  • University of Florida- Jacksonville

    Jacksonville, Florida, 32209

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32216

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Lycoming Internal Medicine, Inc.

    Jersey Shore, Pennsylvania, 17740

  • Wellmont CVA Heart Institute

    Johnson City, Tennessee, 37604

  • Berkley Hills Clinicals

    Johnstown, Pennsylvania, 15905-3443

  • Ilumina Clinical Associates, Johnstown

    Johnstown, Pennsylvania, 15905

  • Joseph Lamantia, DO

    Johnstown, Pennsylvania, 15905

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Westside Family Medical Center, PC

    Kalamazoo, Michigan, 49009

  • Glacier View Cardiology PC

    Kalispell, Montana, 59901

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin, 53142

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee, 37660

  • Texas Cardiology Associates of Houston

    Kingwood, Texas, 77339

  • Diabetes and Endocrine Associates

    La Mesa, California, 91942

  • La Mesa Cardiac Center

    La Mesa, California, 91942

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • Meridien Research

    Lakeland, Florida, 33805

  • Comprehensive Cardiology Consultants

    Langhorne, Pennsylvania, 19047

  • Detweiler Family Medicine and Associates PC

    Lansdale, Pennsylvania, 19446

  • Green & Seidner Family Practice Associates

    Lansdale, Pennsylvania, 19446

  • Cardiology Consultants of East Michigan

    Lapeer, Michigan, 48446

  • Clinical Research Advantage, Inc.

    Las Vegas, Nevada, 89117

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121

  • Clinical Trials of America, Inc.

    Lenoir, North Carolina, 28645

  • Jalil Aziz Khan M.D., P.A.

    Lewisville, Texas, 75067

  • NJ Heart

    Linden, New Jersey, 07036

  • Arkansas Cardiology Clinic

    Little Rock, Arkansas, 72205

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas, 72205

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • Torrance Clinical Research Institute, Inc.

    Lomita, California, 90717

  • Long Beach Center for Clinical Research

    Long Beach, California, 90807

  • Metabolic Clinic and Research Center

    Los Angeles, California, 90033

  • Beverly Hills Cardiology

    Los Angeles, California, 90067

  • VA Greater Los Angeles Health Care System

    Los Angeles, California, 90073

  • Norton Heart Specialists

    Louisville, Kentucky, 40205 3338

  • Norton Heart Specialists

    Louisville, Kentucky, 40205-3338

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • University of Colorado Health

    Loveland, Colorado, 80538

  • Lutherville Personal Physicians

    Lutherville, Maryland, 21093

  • Meriter hospital Inc., DBA: UnityPoint Health-Meriter Heart

    Madison, Wisconsin, 53713

  • INOVA Health Care Services

    Manassas, Virginia, 20109

  • Burke Internal Medicine and Research

    Manassas, Virginia, 20110

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Urban Family Practice Associates/Clinical Research Advantage

    Marietta, Georgia, 30067

  • Awasty Research Network, LLC

    Marion, Ohio, 43302

  • Marquette General Heart and Vascular Institute

    Marquette, Michigan, 49855

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Community Health Care

    Massillon, Ohio, 44646

  • The Endocrine Clinic

    Memphis, Tennessee, 38119

  • ActivMed Practices

    Methuen, Massachusetts, 01844

  • Pharmax Research Clinic, Inc

    Miami, Florida, 33126-2956

  • Life Spring Research Foundation

    Miami, Florida, 33134

  • United Clinical Research Corp.

    Miami, Florida, 33155

  • Cardiovascular Research Center of South Florida

    Miami, Florida, 33173

  • South Florida Research Group LLC

    Miami, Florida, 33176

  • MidMichigan Medical Center

    Midland, Michigan, 48670

  • Midland Clinical Research Center

    Midland, Texas, 79707

  • Rutgers New Jersey Medical School

    Mine Hill, New Jersey, 07103

  • Long Island Heart Associates

    Mineola, New York, 11501

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • South Florida Research Solutions

    Miramar, Florida, 33025

  • Clinical Interventions Research Institute

    Mission Viejo, California, 92692

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Mobile Heart Specialists, PC

    Mobile, Alabama, 36608

  • Diabetes & Endocrinology Consultants

    Morehead City, North Carolina, 28557

  • Burke Primary Care

    Morganton, North Carolina, 28655

  • Medical Consultants PC

    Muncie, Indiana, 47303

  • American Health Network of IN, LLC

    Muncie, Indiana, 47304

  • Cardiology Associates of Northwest Indiana, P.C

    Munster, Indiana, 46321

  • Brigid Freyne MD Inc

    Murrieta, California, 92563

  • Southwest Florida Research

    Naples, Florida, 34102

  • Cardiology Wellness Center

    Nashville, Tennessee, 37203

  • Partners Community Physicians Organization

    Natick, Massachusetts, 01760

  • Partners Community Physicians Organization

    Needham, Massachusetts, 02494

  • North Shore Diabetes and Endocrine Associates

    New Hyde Park, New York, 11042

  • Weill Cornell Medical College

    New York, New York, 10065

  • Red Clay Research

    Newark, Delaware, 19713

  • Capital Area Research LLC

    Newport, Pennsylvania, 17074

  • Health Research of Hampton Roads - Norfolk, Inc.

    Norfolk, Virginia, 23502

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • DiGiovanna Institute for Medical Education

    North Massapequa, New York, 11758

  • Valley Clinical Trials Inc

    Northridge, California, 91325

  • Cardiology Associates of Fairfield County, Norwalk

    Norwalk, Connecticut, 06851

  • Ocala Research Institute, Inc

    Ocala, Florida, 34471

  • Carr Cardiology

    Oceanside, California, 92056

  • Permian Research Foundation

    Odessa, Texas, 79761

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Integris Cardiovascular Physicians LLC

    Oklahoma City, Oklahoma, 73112

  • Memorial Clinical Research

    Oklahoma City, Oklahoma, 73120

  • South Oklahoma Heart Research, LLC

    Oklahoma City, Oklahoma, 73135

  • Oviedo Medical Research

    Oviedo, Florida, 32765

  • Research Integrity LLC

    Owensboro, Kentucky, 42303

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Cardiology Partners Clinical Research Institute

    Palm Beach Gardens, Florida, 33410-4304

  • Palm Beach Gardens Research Center

    Palm Beach Gardens, Florida, 33410

  • Research Physicians Network Alliance, Pembrok

    Pembroke Pines, Florida, 33025

  • South Florida Research Solutions

    Pembroke Pines, Florida, 33028

  • Cardiology Consultants

    Pensacola, Florida, 32501 6335

  • Nisus Research at McLaren Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Endocrine Metabolic Associates

    Philadelphia, Pennsylvania, 19114

  • Pinehurst Medical Clinic, Inc.

    Pinehurst, North Carolina, 28374-8798

  • Medical Clinic of North Texas

    Plano, Texas, 75023

  • Clinical Investigations of Texas, LLC

    Plano, Texas, 75075

  • Clinical Research of Central Florida

    Plant City, Florida, 33563

  • Columbia Primary Care, LLC d/b/a Heart and Health Institute

    Plantation, Florida, 33324

  • St Johns Center for Clinical Research

    Ponte Vedra, Florida, 32081

  • Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341-2985

  • Charlotte Heart Group Research Center

    Port Charlotte, Florida, 33952

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • InterMed, PA

    Portland, Maine, 04101

  • Pottstown Medical Specialists, Inc. (PMSI)

    Pottstown, Pennsylvania, 19464

  • Hudson Valley Heart Center

    Poughkeepsie, New York, 12601

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Northern California Clinical Research Center

    Redding, California, 96001

  • Clinical Research Partners

    Richmond, Virginia, 23220

  • Virginia Cardiovascular Specialists

    Richmond, Virginia, 23229

  • National Clinical Research-Richmond, Inc

    Richmond, Virginia, 23294

  • Remedica LLC

    Rochester, Michigan, 48307

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Advanced CardioVascular Consultants, SC

    Rock Island, Illinois, 61201

  • Brevard Cardiovascular Research Associates Inc

    Rockledge, Florida, 32955

  • Endocrine & Metabolic Consultants

    Rockville, Maryland, 20852

  • PMG Research of Rocky Mount

    Rocky Mount, North Carolina, 27804

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Texas Diabetes

    Round Rock, Texas, 78681

  • Clearwater Cardiovascular and Interventional Cons.

    Safety Harbor, Florida, 34695

  • Michigan CardioVascular Institute

    Saginaw, Michigan, 48601 1423

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

Other trials in United States

Canada38 sites

  • LMC Diabetes & Endocrinology - Brampton

    Brampton, Ontario, L6S0C9

  • McMaster University

    Brampton, Ontario, L6Z 4N5

  • ViaCar Recherche Clinique

    Brossard, Quebec, J4X 1S4

  • JBN Medical Diagnostic Services Inc.

    Burlington, Ontario, L7M 4Y1

  • Aviva Clinical Trial Group In.

    Burlington, Ontario, L7R 1E2

  • LMC Clinical Research Inc. (Calgary)

    Calgary, Alberta, T2H 2G4

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario, N1R 6V6

  • Joanne F. Liutkus Medicine Professional Corp.

    Cambridge, Ontario, N1R 7L6

  • Saul Vizel Professional Medicine Corporation, Vizel Cardiac Research

    Cambridge, Ontario, N1R 7R1

  • LMC Diabetes & Endocrinology (Etobicoke)

    Etobicoke, Ontario, M9R4E1

  • Q&T Research Outaouais Inc.

    Gatineau, Quebec, J8Y 6S8

  • Dr. Dinkar Shukla Professional Medicine Corporation

    Greater Sudbury, Ontario, P3E 6C3

  • Dr Roger Labonte Professional Medicine Corp

    Greater Sudbury, Ontario, P3E3B8

  • ViaCar Recherche Clinique Inc.

    Greenfield Park, Quebec, J4V 2G8

  • Nova Scotia Health Authority /QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • Wharton Medical Clinic Clinical Trials Group Inc.

    Hamilton, Ontario, L8L 5G8

  • Manna Research Inc

    Lévis, Quebec, G6W 0M6

  • Saint Josephs Health Care London

    London, Ontario, N6A 4V2

  • LMC Diabetes & Endocrinoly

    Markham, Ontario, L6B0P9

  • Clinique Sante Cardio MC

    Montreal, Quebec, H1T 3Y7

  • New Market Cardiology Research Group

    Newmarket, Ontario, L3Y 8C3

  • Dr. Michael Heffernan

    Oakville, Ontario, L6K 3W7

  • LMC Clinical Research Inc. (Oakville)

    Oakville, Ontario, L6M 4H8

  • Dr. Cha

    Oshawa, Ontario, L1J 2K1

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Kawartha Cardiology Clinical Trials

    Peterborough, Ontario, K9J 0B2

  • Universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, Quebec, G1V 4G5

  • Centre hospitalier régional de Lanaudière

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • CardioVasc HR, Inc.

    Saint-Jean-sur-Richelieu, Quebec, J3A1C3

  • ViaCar Recherche Clinique Inc.

    Saint-Lambert, Quebec, J4P 2H4

  • LMC Clinical Research Inc. (Montreal)

    Saint-Laurent, Quebec, H4T 1Z9

  • Recherche Clinique London

    Sherbrooke, Quebec, J1J 2E3

  • LMC Diabetes & Endocrinology (Thornhill)

    Thornhill, Ontario, L4J8L7

  • JJ DIG Research Ltd.

    Toronto, Ontario, M3J 1N2

  • Keele Medical Place

    Toronto, Ontario, M3M 3E5

  • LMC Clinical Research Inc. (Bayview)

    Toronto, Ontario, M4G 3E8

  • St Michael's Hospital Health Centre

    Toronto, Ontario, M5C 2T2

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Poland34 sites

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Bezrzecze, 72-003

  • NZOZ "Eskulap"

    Biała Rawska, 96-230

  • Podlaski Osrodek Kardiologii Janusz Korecki

    Bialystok, 15-875

  • Centrum Medyczne KERmed

    Bydgoszcz, 85-231

  • 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

    Bydgoszcz, 85-681

  • Nzoz "Mada-Med"

    Chorzów, 41-500

  • DIABET Centrum Medyczne s. c.

    Chrzanów, 32-500

  • ISPL w Dziedzinie Kardiologii lek.med. Krzysztof Cymerman

    Gdynia, 81-157

  • NZOZ SCBK ProCordis

    Gdynia, 81-423

  • Gabinet Kardiologiczno-Internistyczny

    Gdynia, 81-472

  • Praktyka Lekarska dr n. med. Marek Bronisz

    Inowrocław, 88-100

  • Piotr Mader Diabetic Clinic NZOZ PD-I

    Kamieniec Ząbkowicki, 57-230

  • NZOZ Eskulap SC

    Koluszki, 95-040

  • Ewa Mirek-Bryniarska Specjalistyczna Praktyka Lekarska

    Krakow, 30-082

  • LANDA' Specjalistyczne Gabinety Lekarskie

    Krakow, 31-156

  • Medyczne Centrum Diabetologiczno Endokrynologiczno

    Krakow, 31-261

  • SP ZOZ w Lecznej

    Łęczna, 21-010

  • Nzoz Cardiamed

    Legnica, 59-220

  • NZOZ ALL-MED Centrum Medyczne

    Lodz, 94-048

  • "CenterMed Lublin" Sp. z o.o.

    Lublin, 20-044

  • Indywidualna Praktyka Lekarska

    Mrągowo, 11-700

  • Zechowicz MEDEUSZ-PLUS

    Olsztyn, 10-010

  • Specjalistyczna Przychodnia Lekarska MEDIKARD (SPL Medikard)

    Płock, 09-402

  • Praktyka Lekarska Ewa Krzyzagorska

    Poznan, 61-655

  • NZOZ NEURO-KARD "Ilkowski i Partnerzy"

    Poznan, 61-853

  • Specjalistyczny Gabinet Lekarski

    Tarnów, 33-100

  • Lecznice Citomed Sp. z o.o.

    Torun, 87-100

  • Praktyka Lekarska Pawlowicz Lidia

    Torun, 87-100

  • Centrum Medyczne AMED

    Warsaw, 01-518

  • Centrum Badawcze Wspolczesnej Terapii

    Warsaw, 02-679

  • SNZOZ Fundacji PROCLINICA

    Warsaw, 03-973

  • Centrum Zdrowia Wierzchoslawice

    Wierzchosławice, 33-122

  • Specjalistyczne Gabinety Lekarskie "Medicor PLUS"

    Włocławek, 87-800

  • Regionalna Poradnia Diabetologiczna

    Wroclaw, 50-127

Other trials in Poland

Australia23 sites

  • New Royal Adelaide Hospital, Cardiology Department

    Adelaide, South Australia, 5000

  • South Australian Medical Research Inst, Centre for Clinical Research

    Adelaide, 5000

  • Adelaide Medical Research

    Ashford, South Australia, 5035

  • Ballarat Health Services

    Ballarat, Victoria, 3353

  • Core Research Group

    Brisbane, Queensland, 4064

  • Princess Alexandra Hospital, Cardiology Research Department

    Brisbane, Queensland, 4102

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales, 2450

  • Lyell McEwin Hospital, Department of Cardiology

    Elizabeth Vale, South Australia, 5112

  • Heart and Vascular Institute

    Fullarton, South Australia, SA 5063

  • Geelong Cardiology Research Unit, Barwon Health

    Geelong, Victoria, 3220

  • Gosford Hospital, Cardiology Clinical Trials

    Gosford, New South Wales, 2250

  • Austin Health - Heidelberg Repatriation Hospital, Department of Medicine, Boronia Centre

    Heidelberg Heights, Victoria, 3081

  • Royal Brisbane and Women's Hospital, Endocrinology Department

    Herston, Queensland, 4029

  • Joondalup Cardiovascular Trials Foundation Inc

    Joondalup, Western Australia, 6027

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • HeartCare Partners Clinical Research Unit

    Milton, Queensland, 4064

  • Fiona Stanley Hospital, Cardiology Research Department,CDO11

    Murdoch, Western Australia, 6150

  • Avenue Cardiovascular Centre

    Saint Kilda East, Victoria, 3183

  • AusTrials Pty Ltd

    Sherwood, Queensland, 4075

  • Gold Coast Hospital, Cardiovascular Research Centre

    Southport, Queensland, 4215

  • Illawarra Shoalhaven Local Health District, Clinical Trial and Research Unit

    Wollongong, New South Wales, 2500

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

New Zealand13 sites

  • Auckland City Hospital

    Auckland, 1148

  • Christchurch Hospital, Lipids

    Christchurch, Canterbury, 8011

  • Christchurch Hospital, Cardiology Research

    Christchurch, Canterbury, 8811

  • Dunedin Hospital

    Dunedin, Otago, 9016

  • Hawkes Bay Regional Hospital

    Hastings, 4120

  • Hutt Hospital, Cardiology Dept

    Lower Hutt, Wellington Region, 5010

  • North Shore Hospital-Cardiology Research

    Milford, Auckland, 0622

  • Nelson Hospital, Cardiology Department

    Nelson, 7010

  • Taranaki Base Hospital

    New Plymouth, Taranaki Region, 4310

  • Middlemore Hospital

    Papatoetoe, Auckland, 2025

  • Lakeland Clinical Trials, Rotorua

    Rotorua, 3010

  • North Shore Hospital - Diabetes Clinic

    Takapuna, Auckland, 0740

  • Tauranga Hospital

    Tauranga, 3112

Other trials in New Zealand

Mexico9 sites

  • Fundacion Cardiovascular de Aguascalientes

    Aguascalientes, 20230

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20230

  • Mentrials S.A.de C.V.

    Distrito Federal, 06700

  • ICLE

    Guadalajara, Jalisco, 44600

  • Private Medical Practice

    Guadalajara, Jalisco, 44657

  • IMED Clin Trials

    Monterrey, Nuevo León, 64020

  • Cardiolink ClinTrials S.C.

    Monterrey, Nuevo León, 64060

  • Centro de Estudios Clinicos y Especialidades Medicas S.C.

    Monterrey, Nuevo León, 64620

  • Hospital de Angeles Xalapa

    Xalapa, Veracruz, 91193

Other trials in Mexico

Chile8 sites

  • Hospital Regional Concepcion

    Concepción, 4070038

  • Biomedica Research Group

    Providencia, Santiago Metropolitan, 7500710

  • Sociedad Medica Cardiologica El Llano

    San Miguel, Santiago Metropolitan, 8910259

  • Cardiocob

    Santiago, 7500520

  • Servicios Medicos Godoy Ltda.

    Santiago, 7500710

  • Ccbr Cecim

    Santiago, 8331143

  • Centro Investigacion Clinica del Sur

    Temuco, 4781156

  • CECMI Ltda.

    Temuco, 4813299

Other trials in Chile

The Bahamas1 site

  • The Partners Clinical Research Centre

    Nassau

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors

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.

Read the detailed description

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

Being tested
Lorcaserin hydrochloride, Placebo
Keywords
Diabetes, Cardiovascular Disease, Multiple Cardiovascular Risk Factors, Obesity, Overweight, MACE, Conversion to Diabetes
Medical subject headings
Cardiovascular Diseases, Obesity, Overweight, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lorcaserin hydrochlorideDrug

    Also called APD356, BELVIQ

    APD356 10 mg twice daily

  • PlaceboDrug

    Placebo twice daily

Study groups in NCT02019264
Study groupRoleWhat they receive
Lorcaserin hydrochloride (HCL)10 mgExperimentalAPD356 10 mg twice daily
Receives: Drug: Lorcaserin hydrochloride
PlaceboPlacebo comparatorPlacebo twice daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to Month 42

  2. 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.

    Measured: Baseline up to end of study (Month 56)

Secondary outcomes (13)

  1. 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.

    Measured: Baseline up to end of study (Month 56)

  2. 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.

    Measured: Baseline up to end of study (Month 56)

  3. Time From Randomization to Event of All-cause Mortality

    The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

    Measured: Baseline up to end of study (Month 56)

  4. 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.

    Measured: Baseline up to end of study (Month 56)

  5. 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.

    Measured: Baseline up to end of study (Month 56)

  6. Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline

    Measured: Baseline, and Month 6

  7. 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.

    Measured: Baseline up to end of study (Month 56)

  8. 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.

    Measured: Baseline up to end of study (Month 56)

  9. 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.

    Measured: Baseline up to end of study (Month 56)

  10. 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.

    Measured: Baseline up to end of study (Month 56)

  11. Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes

    Measured: Months 6 and 12

  12. Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy

    Measured: Months 6 and 12

  13. Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure

    Measured: Baseline, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2013 (estimated)
  2. Study start24 Jan 2014
  3. Primary completion14 May 2018
  4. Study completion14 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
14,673 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02019264
Sponsor's protocol ID
APD356-G000-401
Other IDs
2013-000324-34
Acronym
CAMELLIA-TIMI
Status last verified
Nov 2017
First submitted
18 Dec 2013
Last updated
16 Jul 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes

Publications

  • 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.

    PubMed 30586726

  • 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.

    PubMed 30293771

  • 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.

    PubMed 30145941

  • 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.

    PubMed 29803985

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lorcaserin hydrochloride in people with Cardiovascular Disease and High Cardiovascular Risk, run by Eisai Inc. at 499 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 499 sites in United States, Canada, Poland, Australia, New Zealand and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis (time frame: Baseline up to Month 42). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02019264, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.

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CAMELLIA-TIMI Clinical Trial NCT02019264 | AzTrials