Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02019264
Registration number
NCT02019264
Ethics application status
Date submitted
18/12/2013
Date registered
24/12/2013
Date last updated
16/07/2019
Titles & IDs
Public 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
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2013-000324-34
Query!
Secondary ID [2]
0
0
APD356-G000-401
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CAMELLIA-TIMI
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease
0
0
Query!
High Cardiovascular Risk
0
0
Query!
Obesity
0
0
Query!
Overweight
0
0
Query!
Type 2 Diabetes
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Diet and Nutrition
0
0
0
0
Query!
Obesity
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Lorcaserin hydrochloride
Treatment: Drugs - Placebo
Experimental: Lorcaserin hydrochloride (HCL)10 mg - APD356 10 mg twice daily
Placebo Comparator: Placebo - Placebo twice daily
Treatment: Drugs: Lorcaserin hydrochloride
APD356 10 mg twice daily
Treatment: Drugs: Placebo
Placebo twice daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis
Query!
Assessment method [1]
0
0
The MACE events involved myocardial infarction (MI), stroke, or cardiovascular (CV) death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Query!
Timepoint [1]
0
0
Baseline up to Month 42
Query!
Primary outcome [2]
0
0
Time From Randomization to First Occurrence of MACE+
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline up to end of study (Month 56)
Query!
Secondary outcome [1]
0
0
Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Participants With Prediabetes at Baseline
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline up to end of study (Month 56)
Query!
Secondary outcome [2]
0
0
Time From Randomization to First Occurrence of the Individual Components of MACE+
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline up to end of study (Month 56)
Query!
Secondary outcome [3]
0
0
Time From Randomization to Event of All-cause Mortality
Query!
Assessment method [3]
0
0
The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Query!
Timepoint [3]
0
0
Baseline up to end of study (Month 56)
Query!
Secondary outcome [4]
0
0
Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline up to end of study (Month 56)
Query!
Secondary outcome [5]
0
0
Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline
Query!
Assessment method [5]
0
0
The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Query!
Timepoint [5]
0
0
Baseline up to end of study (Month 56)
Query!
Secondary outcome [6]
0
0
Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Baseline, and Month 6
Query!
Secondary outcome [7]
0
0
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline up to end of study (Month 56)
Query!
Secondary outcome [8]
0
0
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline up to end of study (Month 56)
Query!
Secondary outcome [9]
0
0
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline up to end of study (Month 56)
Query!
Secondary outcome [10]
0
0
Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline up to end of study (Month 56)
Query!
Secondary outcome [11]
0
0
Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Months 6 and 12
Query!
Secondary outcome [12]
0
0
Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Months 6 and 12
Query!
Secondary outcome [13]
0
0
Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
Baseline, Month 12
Query!
Eligibility
Key inclusion criteria
Inclusion Criteria
1. BMI greater than or equal (>=) to 27 kilogram per meter square (kg/m^2)
2. Subjects able and willing to comply with a reduced-calorie diet and an increased
physical activity program
3. Age >= to 40 years with established CV disease as defined by one of the following:
1. History of documented MI or ischemic stroke
2. History of peripheral artery disease
3. History of revascularization (coronary, carotid, or peripheral artery)
4. Significant unrevascularized coronary arterial stenosis
OR
Age >= to 55 years for women or >= to 50 years for men who have type 2 diabetes mellitus
(T2DM) without established CV disease plus at least one of the following CV risk factors:
1. Hypertension, or currently receiving therapy for documented hypertension
2. Dyslipidemia, or currently taking prescription lipid-lowering therapy for documented
dyslipidemia
3. Estimated glomerular filtration rate >= to 30 to less than equal (<=) to 60 mililitre
per minute per 1.73 meter square (mL/min/1.73 m^) per the Chronic Kidney Disease
Epidemiology Collaboration (CKD-EPI) equation
4. High high sensitivity C-reactive protein (hsCRP)
5. Urinary albumin-to-creatinine ratio (ACR) >= 30 ug/mg
Subjects with T2DM may have a pre-existing or new diagnosis of T2DM. A new diagnosis of
T2DM (ie, discovered at Screening) should be based on the 2013 American Diabetes
Association (ADA) guidelines.
All T2DM subjects must have an HbA[1c] less (<) than 10% at Screening. If subjects are
being treated, or upon diagnosis need to be treated with antidiabetic agents, the T2DM
treatment regimen must be stable for at least 3 months prior to randomization.
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion Criteria
1. Moderate or greater symptoms of congestive cardiac failure (New York Heart Association
[NYHA] class III or IV)
2. Known left ventricular (LV) ejection fraction < than 20%
3. Moderate or greater symptoms of pulmonary hypertension (PH)
4. Known severe valvular disease
5. Moderate renal impairment, severe renal impairment (estimated glomerular filtration
rate < 30 mL/min/1.73 m^ per the CKD-EPI equation based on ideal body weight), or end
stage renal disease (ESRD)
6. Severe hepatic impairment
7. Use of other products intended for weight loss including prescription drugs,
over-the-counter (OTC) drugs, and herbal preparations
8. Use of more than one other serotonergic drug
9. Use of drugs known to increase the risk for cardiac valvulopathy within 6 months prior
to Screening including, but not limited to: pergolide, ergotamine, methysergide,
cabergoline
10. History or evidence of clinically significant disease (e.g., malignancy, cardiac,
respiratory, gastrointestinal, renal or psychiatric disease)
11. Use of lorcaserin HCl prior to Screening or hypersensitivity to lorcaserin HCl or any
of the excipients
12. Planned bariatric surgery
13. Females must not be breastfeeding or pregnant
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
24/01/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
14/05/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
14673
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Coffs Harbour Health Campus - Coffs Harbour
Query!
Recruitment hospital [2]
0
0
Gosford Hospital, Cardiology Clinical Trials - Gosford
Query!
Recruitment hospital [3]
0
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [4]
0
0
Illawarra Shoalhaven Local Health District, Clinical Trial and Research Unit - Wollongong
Query!
Recruitment hospital [5]
0
0
Wollongong Hospital - Wollongong
Query!
Recruitment hospital [6]
0
0
Core Research Group - Brisbane
Query!
Recruitment hospital [7]
0
0
Princess Alexandra Hospital, Cardiology Research Department - Brisbane
Query!
Recruitment hospital [8]
0
0
Royal Brisbane and Women's Hospital, Endocrinology Department - Herston
Query!
Recruitment hospital [9]
0
0
HeartCare Partners Clinical Research Unit - Milton
Query!
Recruitment hospital [10]
0
0
AusTrials Pty Ltd - Sherwood
Query!
Recruitment hospital [11]
0
0
Gold Coast Hospital, Cardiovascular Research Centre - Southport
Query!
Recruitment hospital [12]
0
0
New Royal Adelaide Hospital, Cardiology Department - Adelaide
Query!
Recruitment hospital [13]
0
0
Adelaide Medical Research - Ashford
Query!
Recruitment hospital [14]
0
0
Lyell McEwin Hospital, Department of Cardiology - Elizabeth Vale
Query!
Recruitment hospital [15]
0
0
Heart and Vascular Institute - Fullarton
Query!
Recruitment hospital [16]
0
0
The Queen Elizabeth Hospital - Woodville South
Query!
Recruitment hospital [17]
0
0
Ballarat Health Services - Ballarat
Query!
Recruitment hospital [18]
0
0
Geelong Cardiology Research Unit, Barwon Health - Geelong
Query!
Recruitment hospital [19]
0
0
Austin Health - Heidelberg Repatriation Hospital, Department of Medicine, Boronia Centre - Heidelberg Heights
Query!
Recruitment hospital [20]
0
0
Avenue Cardiovascular Centre - Saint Kilda East
Query!
Recruitment hospital [21]
0
0
Joondalup Cardiovascular Trials Foundation Inc - Joondalup
Query!
Recruitment hospital [22]
0
0
Fiona Stanley Hospital, Cardiology Research Department,CDO11 - Murdoch
Query!
Recruitment hospital [23]
0
0
South Australian Medical Research Inst, Centre for Clinical Research - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
2450 - Coffs Harbour
Query!
Recruitment postcode(s) [2]
0
0
2250 - Gosford
Query!
Recruitment postcode(s) [3]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [4]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [5]
0
0
4064 - Brisbane
Query!
Recruitment postcode(s) [6]
0
0
4102 - Brisbane
Query!
Recruitment postcode(s) [7]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [8]
0
0
4064 - Milton
Query!
Recruitment postcode(s) [9]
0
0
4075 - Sherwood
Query!
Recruitment postcode(s) [10]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [11]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [12]
0
0
5035 - Ashford
Query!
Recruitment postcode(s) [13]
0
0
5112 - Elizabeth Vale
Query!
Recruitment postcode(s) [14]
0
0
SA 5063 - Fullarton
Query!
Recruitment postcode(s) [15]
0
0
5011 - Woodville South
Query!
Recruitment postcode(s) [16]
0
0
3353 - Ballarat
Query!
Recruitment postcode(s) [17]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [18]
0
0
3081 - Heidelberg Heights
Query!
Recruitment postcode(s) [19]
0
0
3183 - Saint Kilda East
Query!
Recruitment postcode(s) [20]
0
0
6027 - Joondalup
Query!
Recruitment postcode(s) [21]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Alaska
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arizona
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Arkansas
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
California
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Colorado
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Connecticut
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Delaware
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Florida
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Georgia
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Illinois
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Indiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Iowa
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Kansas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Kentucky
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Maine
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Maryland
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Massachusetts
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Michigan
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Minnesota
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Mississippi
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Missouri
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Montana
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Nebraska
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Nevada
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
New Jersey
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
New Mexico
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
New York
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
North Carolina
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
North Dakota
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Ohio
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Oklahoma
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Pennsylvania
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Rhode Island
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
South Carolina
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
South Dakota
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Tennessee
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Texas
Query!
Country [39]
0
0
United States of America
Query!
State/province [39]
0
0
Utah
Query!
Country [40]
0
0
United States of America
Query!
State/province [40]
0
0
Virginia
Query!
Country [41]
0
0
United States of America
Query!
State/province [41]
0
0
Washington
Query!
Country [42]
0
0
United States of America
Query!
State/province [42]
0
0
Wisconsin
Query!
Country [43]
0
0
Bahamas
Query!
State/province [43]
0
0
Nassau
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Alberta
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
British Columbia
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Nova Scotia
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Ontario
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Quebec
Query!
Country [49]
0
0
Chile
Query!
State/province [49]
0
0
Santiago
Query!
Country [50]
0
0
Chile
Query!
State/province [50]
0
0
Concepcion
Query!
Country [51]
0
0
Chile
Query!
State/province [51]
0
0
Temuco
Query!
Country [52]
0
0
Mexico
Query!
State/province [52]
0
0
Jalisco
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Nuevo Leon
Query!
Country [54]
0
0
Mexico
Query!
State/province [54]
0
0
Veracruz
Query!
Country [55]
0
0
Mexico
Query!
State/province [55]
0
0
Aguascalientes
Query!
Country [56]
0
0
Mexico
Query!
State/province [56]
0
0
Distrito Federal
Query!
Country [57]
0
0
New Zealand
Query!
State/province [57]
0
0
Auckland
Query!
Country [58]
0
0
New Zealand
Query!
State/province [58]
0
0
Canterbury
Query!
Country [59]
0
0
New Zealand
Query!
State/province [59]
0
0
Otago
Query!
Country [60]
0
0
New Zealand
Query!
State/province [60]
0
0
Taranaki
Query!
Country [61]
0
0
New Zealand
Query!
State/province [61]
0
0
Wellington
Query!
Country [62]
0
0
New Zealand
Query!
State/province [62]
0
0
Hastings
Query!
Country [63]
0
0
New Zealand
Query!
State/province [63]
0
0
Nelson
Query!
Country [64]
0
0
New Zealand
Query!
State/province [64]
0
0
Rotorua
Query!
Country [65]
0
0
New Zealand
Query!
State/province [65]
0
0
Tauranga
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Bezrzecze
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Biala Rawska
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Bialystok
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Bydgoszcz
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Chorzów
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Chrzanów
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Gdynia
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Inowroclaw
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Kamieniec Zabkowicki
Query!
Country [75]
0
0
Poland
Query!
State/province [75]
0
0
Koluszki
Query!
Country [76]
0
0
Poland
Query!
State/province [76]
0
0
Kraków
Query!
Country [77]
0
0
Poland
Query!
State/province [77]
0
0
Legnica
Query!
Country [78]
0
0
Poland
Query!
State/province [78]
0
0
Lublin
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Mragowo
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Olsztyn
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Poznan
Query!
Country [82]
0
0
Poland
Query!
State/province [82]
0
0
Plock
Query!
Country [83]
0
0
Poland
Query!
State/province [83]
0
0
Tarnów
Query!
Country [84]
0
0
Poland
Query!
State/province [84]
0
0
Torun
Query!
Country [85]
0
0
Poland
Query!
State/province [85]
0
0
Warszawa
Query!
Country [86]
0
0
Poland
Query!
State/province [86]
0
0
Wierzchoslawice
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Wroclaw
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Wloclawek
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Lódz
Query!
Country [90]
0
0
Poland
Query!
State/province [90]
0
0
Leczna
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Eisai Inc.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Thrombolysis In Myocardial Infarction (TIMI) Academic Research Organization
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02019264
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02019264
Download to PDF