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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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2013-000324-34
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Secondary ID [2]
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APD356-G000-401
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Universal Trial Number (UTN)
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Trial acronym
CAMELLIA-TIMI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease
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High Cardiovascular Risk
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Obesity
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Overweight
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Type 2 Diabetes
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Diet and Nutrition
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Obesity
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis
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Assessment method [1]
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The MACE events involved myocardial infarction (MI), stroke, or cardiovascular (CV) death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
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Timepoint [1]
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Baseline up to Month 42
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Primary outcome [2]
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Time From Randomization to First Occurrence of MACE+
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to end of study (Month 56)
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Secondary outcome [1]
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Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Participants With Prediabetes at Baseline
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to end of study (Month 56)
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Secondary outcome [2]
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Time From Randomization to First Occurrence of the Individual Components of MACE+
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to end of study (Month 56)
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Secondary outcome [3]
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Time From Randomization to Event of All-cause Mortality
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Assessment method [3]
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The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
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Timepoint [3]
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Baseline up to end of study (Month 56)
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Secondary outcome [4]
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Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline up to end of study (Month 56)
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Secondary outcome [5]
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Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline
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Assessment method [5]
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The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
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Timepoint [5]
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Baseline up to end of study (Month 56)
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Secondary outcome [6]
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Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline
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Assessment method [6]
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Timepoint [6]
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Baseline, and Month 6
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Secondary outcome [7]
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Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline up to end of study (Month 56)
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Secondary outcome [8]
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Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline up to end of study (Month 56)
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Secondary outcome [9]
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Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline up to end of study (Month 56)
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Secondary outcome [10]
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Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline up to end of study (Month 56)
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Secondary outcome [11]
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Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes
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Assessment method [11]
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Timepoint [11]
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Months 6 and 12
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Secondary outcome [12]
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Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy
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Assessment method [12]
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Timepoint [12]
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Months 6 and 12
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Secondary outcome [13]
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Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure
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Assessment method [13]
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Timepoint [13]
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Baseline, Month 12
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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.
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/05/2018
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Sample size
Target
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Accrual to date
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Final
14673
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Coffs Harbour Health Campus - Coffs Harbour
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Gosford Hospital, Cardiology Clinical Trials - Gosford
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Liverpool Hospital - Liverpool
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Illawarra Shoalhaven Local Health District, Clinical Trial and Research Unit - Wollongong
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Wollongong Hospital - Wollongong
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Core Research Group - Brisbane
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Princess Alexandra Hospital, Cardiology Research Department - Brisbane
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Royal Brisbane and Women's Hospital, Endocrinology Department - Herston
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Recruitment hospital [9]
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HeartCare Partners Clinical Research Unit - Milton
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AusTrials Pty Ltd - Sherwood
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Gold Coast Hospital, Cardiovascular Research Centre - Southport
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New Royal Adelaide Hospital, Cardiology Department - Adelaide
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Adelaide Medical Research - Ashford
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Lyell McEwin Hospital, Department of Cardiology - Elizabeth Vale
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Heart and Vascular Institute - Fullarton
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The Queen Elizabeth Hospital - Woodville South
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Ballarat Health Services - Ballarat
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Geelong Cardiology Research Unit, Barwon Health - Geelong
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Austin Health - Heidelberg Repatriation Hospital, Department of Medicine, Boronia Centre - Heidelberg Heights
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Avenue Cardiovascular Centre - Saint Kilda East
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Recruitment hospital [21]
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Joondalup Cardiovascular Trials Foundation Inc - Joondalup
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Recruitment hospital [22]
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Fiona Stanley Hospital, Cardiology Research Department,CDO11 - Murdoch
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Recruitment hospital [23]
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South Australian Medical Research Inst, Centre for Clinical Research - Adelaide
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2450 - Coffs Harbour
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2250 - Gosford
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2170 - Liverpool
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2500 - Wollongong
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4064 - Brisbane
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4102 - Brisbane
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4029 - Herston
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4064 - Milton
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4075 - Sherwood
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4215 - Southport
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Recruitment postcode(s) [11]
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5000 - Adelaide
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5035 - Ashford
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5112 - Elizabeth Vale
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SA 5063 - Fullarton
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5011 - Woodville South
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3353 - Ballarat
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3220 - Geelong
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3081 - Heidelberg Heights
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3183 - Saint Kilda East
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6027 - Joondalup
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Recruitment postcode(s) [21]
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6150 - Murdoch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eisai Inc.
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Thrombolysis In Myocardial Infarction (TIMI) Academic Research Organization
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02019264
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Trial related presentations / 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. 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.
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Public notes
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Contacts
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/64/NCT02019264/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/64/NCT02019264/SAP_001.pdf
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https://clinicaltrials.gov/study/NCT02019264
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