A Phase 4 interventional study of Lorcaserin hydrochloride and Placebo in Cardiovascular Disease, High Cardiovascular Risk and Obesity, sponsored by Eisai Inc.. Completed at 499 sites in 8 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-07-16.
Sponsored by Eisai Inc. · Phase 4, Interventional, and Treatment
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.
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's enrollment of 14,673 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Eisai Inc. is the lead sponsor of 368 studies on the registry; 7 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 56 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age >= to 40 years with established CV disease as defined by one of the following:
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:
Subjects with T2DM may have a pre-existing or new diagnosis of T2DM. A new diagnosis of T2DM (ie, discovered at Screening) should be based on the 2013 American Diabetes Association (ADA) guidelines.
All T2DM subjects must have an HbA[1c] less (\<) than 10% at Screening. If subjects are being treated, or upon diagnosis need to be treated with antidiabetic agents, the T2DM treatment regimen must be stable for at least 3 months prior to randomization.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
APD356 10 mg twice daily
Drug: Lorcaserin hydrochloride
Placebo twice daily
Drug: Placebo
APD356 10 mg twice daily
Also known as: APD356, BELVIQ
Placebo twice daily
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.
Time frame: Baseline up to Month 42
Time From Randomization to First Occurrence of MACE+
The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or heart failure (HF), or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Time frame: Baseline up to end of study (Month 56)
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.
Time frame: Baseline up to end of study (Month 56)
Time From Randomization to First Occurrence of the Individual Components of MACE+
The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or HF, or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Time frame: Baseline up to end of study (Month 56)
Time From Randomization to Event of All-cause Mortality
The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Time frame: Baseline up to end of study (Month 56)
Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline
Normal glucose homeostasis was defined as HbA1c less than or equal to (\<=) 5.6% and FPG \< 100 mg/dL without any antidiabetic treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Time frame: Baseline up to end of study (Month 56)
Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline
The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Time frame: Baseline up to end of study (Month 56)
Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline
Time frame: Baseline, and Month 6
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants
New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (albumin-to-creatinine ratio \[ACR\] \>=30mcg/mg and ACR\>=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at Baseline developed macroalbuminuria, ACR increased \>=30% from Baseline during treatment), newly developed chronic kidney disease (CKD) (eGFR \>=90 milliliter per minute per 1.73 \[mL/min/1.73\]body surface area (BSA) and without kidney damage at Baseline changed to CKD Stage 1/higher as per National Kidney Foundation \[NKF\] Guidelines \[2002\]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines \[2002\] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times Baseline value and \>=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Time frame: Baseline up to end of study (Month 56)
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline
New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR \>=30mcg/mg and ACR \>=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased \>=30% from baseline during treatment), CKD (eGFR \>=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines \[2002\]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines \[2002\] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and \>=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Time frame: Baseline up to end of study (Month 56)
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline
New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR \>=30 mcg/mg and ACR \>=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased \>=30% from baseline during treatment), CKD (eGFR \>=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines \[2002\]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines \[2002\] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and \>=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Time frame: Baseline up to end of study (Month 56)
Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline
Improvement in renal function was defined as first occurrence of regression of albuminuria or regression of CKD. Regression of albuminuria was defined as when participants with macroalbuminuria at baseline developed microalbuminuria or nonalbuminuria (ACR \<30 mcg/mg in spot urine), or participants with microalbuminuria at baseline became nonalbuminuric, and ACR value decreased \>= 30% from previous assessment during treatment. Regression of CKD defined as when participants with CKD Stage 1 or higher at baseline improved to normal or lower stages by NKF guidelines (eGFR \>=90 with albuminuria at baseline improved to eGFR \>=90 without albuminuria, or eGFR 60 to 89 at baseline became eGFR \>=90 with or without albuminuria, or eGFR between 30 to 59 at baseline improved to \>60 mL/min/1.73 BSA) during treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Time frame: Baseline up to end of study (Month 56)
Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes
Time frame: Months 6 and 12
Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy
Time frame: Months 6 and 12
Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure
Time frame: Baseline, Month 12
Participants took part in the study at investigative sites in the United States, Bahamas, Canada, Mexico, Chile, New Zealand, Poland, and Australia from 24 Jan 2014 to 14 May 2018.
| Milestone | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Started | 6000 | 6000 |
| Safety analysis set | 5992 | 5995 |
| Completed | 5752 | 5793 |
| Not completed | 248 | 207 |
| Withdrew: Not treated | 6 | 4 |
| Withdrew: Lost to follow-up | 50 | 47 |
| Withdrew: Withdrawal by subject | 142 | 117 |
| Withdrew: Administrative reason | 36 | 28 |
| Withdrew: Missing | 14 | 11 |
The MACE events involved myocardial infarction (MI), stroke, or cardiovascular (CV) death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
| days | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis | NA (NA to NA) | NA (NA to NA) |
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.
| days | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Time From Randomization to First Occurrence of MACE+ | NA (NA to NA) | NA (NA to NA) |
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.
| days | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Participants With Prediabetes at Baseline | NA (NA to NA) | NA (NA to NA) |
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.
| days | Placebo | Lorcaserin 10 mg |
|---|---|---|
| MI | NA (NA to NA) | NA (NA to NA) |
| Stroke | NA (NA to NA) | NA (NA to NA) |
| CV death | NA (NA to NA) | NA (NA to NA) |
| Hospitalization for unstable angina | NA (NA to NA) | NA (NA to NA) |
| HF | NA (NA to NA) | NA (NA to NA) |
| Coronary revascularization | NA (NA to NA) | NA (NA to NA) |
The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
| days | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Time From Randomization to Event of All-cause Mortality | NA (NA to NA) | NA (NA to NA) |
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.
| days | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline | NA (NA to NA) | NA (NA to NA) |
The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
| days | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline | NA (NA to NA) | NA (NA to NA) |
| percentage of HbA1c | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Baseline | 6.99 ± 1.066 | 7.01 ± 1.082 |
| Change at Month 6 | 0.06 ± 0.777 | -0.33 ± 0.785 |
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.
| days | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants | NA (NA to NA) | NA (NA to NA) |
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.
| days | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline | NA (NA to NA) | NA (NA to NA) |
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.
| days | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline | NA (NA to NA) | NA (NA to NA) |
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.
| days | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline | NA (NA to NA) | NA (NA to NA) |
| percentage of participants | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Month 6 | 1.4 | 2.1 |
| Month 12 | 1.5 | 1.8 |
| percentage of participants | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Month 6 | 2.1 | 3.5 |
| Month 12 | 1.7 | 2.1 |
| Millimeter of mercury (mmHg) | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Baseline | 26.4354 ± 7.66312 | 26.2029 ± 7.54123 |
| Change at Month 12 | -0.6418 ± 6.81716 | -0.8223 ± 7.23770 |
Collected over From baseline up to 30 days after last dose of study drug (approximately 56 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 202/5,992 (3.4%) | 2,021/5,992 (33.7%) | 4,788/5,992 (79.9%) |
| Lorcaserin 10 mg | 219/5,995 (3.7%) | 1,974/5,995 (32.9%) | 4,946/5,995 (82.5%) |
| Event | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Angina pectorisCardiac disorders | 123/5992 | 142/5995 |
| Non-cardiac chest painGeneral disorders | 132/5992 | 133/5995 |
| Acute myocardial infarctionCardiac disorders | 117/5992 | 105/5995 |
| Angina unstableCardiac disorders | 106/5992 | 113/5995 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 109/5992 | 93/5995 |
| Cardiac failure congestiveCardiac disorders | 106/5992 | 91/5995 |
| Atrial fibrillationCardiac disorders | 102/5992 | 105/5995 |
| PneumoniaInfections and infestations | 86/5992 | 92/5995 |
| Coronary artery diseaseCardiac disorders | 78/5992 | 87/5995 |
| CellulitisInfections and infestations | 71/5992 | 48/5995 |
| Event | Placebo | Lorcaserin 10 mg |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 567/5992 | 528/5995 |
| DizzinessNervous system disorders | 340/5992 | 537/5995 |
| FatigueGeneral disorders | 302/5992 | 496/5995 |
| BronchitisInfections and infestations | 468/5992 | 455/5995 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 452/5992 | 457/5995 |
| Back painMusculoskeletal and connective tissue disorders | 452/5992 | 457/5995 |
| Urinary tract infectionInfections and infestations | 400/5992 | 440/5995 |
| DiarrhoeaGastrointestinal disorders | 324/5992 | 419/5995 |
| HeadacheNervous system disorders | 274/5992 | 383/5995 |
| CoughRespiratory, thoracic and mediastinal disorders | 303/5992 | 376/5995 |
The full analysis (FA) set included all randomized participants regardless of whether they took study drug or not.
| Age, Continuous(years) | Placebo | Lorcaserin 10 mg | Total |
|---|---|---|---|
| Mean | 63.7 ± 8.31 | 63.5 ± 8.33 | 63.6 ± 8.32 |
| Sex: Female, Male(Participants) | Placebo | Lorcaserin 10 mg | Total |
|---|---|---|---|
| Female | 2186 | 2112 | 4298 |
| Male | 3814 | 3888 | 7702 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Lorcaserin 10 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 536 | 502 | 1038 |
| Not Hispanic or Latino | 5464 | 5498 | 10962 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Lorcaserin 10 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 21 | 26 | 47 |
| Asian | 74 | 85 | 159 |
| Native Hawaiian or Other Pacific Islander | 23 | 30 | 53 |
| Black or African American | 466 | 454 | 920 |
| White | 5331 | 5309 | 10640 |
| More than one race | 85 | 96 | 181 |
| Unknown or Not Reported | 0 | 0 | 0 |
Showing the first 100 of 499 sites across 8 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2014 to primary completion in May 2018, 51 months.
Results were first posted in Jul 2019, 1 year 2 months after primary completion.
Of 113 phase 4 interventional studies under Cardiovascular Diseases, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 64. This study's 51 months is above that.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lorcaserin