ID

35171

Beschreibung

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; ODM derived from: https://clinicaltrials.gov/show/NCT02019264

Link

https://clinicaltrials.gov/show/NCT02019264

Stichworte

Versionen (1)
  1. 21.02.19 21.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. Februar 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT02019264

Englisch

Eligibility Cardiovascular Disease NCT02019264

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. bmi greater than or equal to 27 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
2. subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program
Beschreibung

Compliance behavior Low-Calorie Diet | Compliance behavior Increased physical activity levels

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2930544
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0851792
3. age greater than or equal to 40 years with established cv disease as defined by one of the following:
Beschreibung

Age | Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0007222
1. history of documented mi or ischemic stroke
Beschreibung

Myocardial Infarction | Ischemic stroke

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0948008
2. history of peripheral artery disease
Beschreibung

Peripheral Arterial Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1704436
3. history of revascularization (coronary, carotid, or peripheral artery)
Beschreibung

Coronary revascularisation | Carotid revascularisation | Peripheral revascularisation

Datentyp

boolean

Alias
UMLS CUI [1]
C0877341
UMLS CUI [2]
C3495793
UMLS CUI [3]
C1096418
4. significant unrevascularized coronary arterial stenosis
Beschreibung

Coronary Stenosis | Revascularization Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0242231
UMLS CUI [2,1]
C0581603
UMLS CUI [2,2]
C0332197
age greater than or equal to 55 years for women or greater than or equal to 50 years for men who have t2dm without established cv disease plus at least one of the following cv risk factors:
Beschreibung

Age | Gender | Diabetes Mellitus, Non-Insulin-Dependent | Cardiovascular Disease Absent | Cardiovascular risk factor Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0011860
UMLS CUI [4,1]
C0007222
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0850624
UMLS CUI [5,2]
C1265611
1. hypertension, or currently receiving therapy for documented hypertension
Beschreibung

Hypertensive disease | Therapeutic procedure Hypertensive disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0020538
2. dyslipidemia, or currently taking prescription lipid-lowering therapy for documented dyslipidemia
Beschreibung

Dyslipidemia | Lipid-lowering therapy Dyslipidemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0242339
UMLS CUI [2,1]
C0585943
UMLS CUI [2,2]
C0242339
3. calculated creatinine clearance greater than or equal to 30 to less than or equal to 60 ml/min per the chronic kidney disease epidemiology collaboration (ckd-epi) equation
Beschreibung

Creatinine clearance measurement Creatinine-based formula (CKD-EPI)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0373595
UMLS CUI [1,2]
C2964649
4. high hscrp
Beschreibung

High-sensitivity C-reactive protein increased

Datentyp

boolean

Alias
UMLS CUI [1]
C1963867
5. urinary albumin-to-creatinine ratio (acr) greater than or equal to 30 ug/mg
Beschreibung

Urine albumin/creatinine ratio measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0455271
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.
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Pre-existing | Non-Insulin-Dependent Diabetes Mellitus Newly Diagnosed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C1518321
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.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Antidiabetics | Therapeutic procedure Stable Non-Insulin-Dependent Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0935929
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0205360
UMLS CUI [4,3]
C0011860
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. moderate or greater symptoms of congestive cardiac failure (new york heart association [nyha] class iii or iv)
Beschreibung

Moderate signs/symptoms Congestive heart failure New York Heart Association Classification | Symptom severe Congestive heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3846034
UMLS CUI [1,2]
C0018802
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0436345
UMLS CUI [2,2]
C0018802
UMLS CUI [2,3]
C1275491
2. known left ventricular (lv) ejection fraction less than 20%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
3. moderate or greater symptoms of pulmonary hypertension (ph)
Beschreibung

Moderate signs/symptoms Pulmonary Hypertension | Symptom severe Pulmonary Hypertension

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3846034
UMLS CUI [1,2]
C0020542
UMLS CUI [2,1]
C0436345
UMLS CUI [2,2]
C0020542
4. known severe valvular disease moderate renal impairment, severe renal impairment, or end stage renal disease (esrd) (calculated creatinine clearance less than 30 ml/min per the ckd-epi equation based on ideal body weight)
Beschreibung

Valvular disease | Renal Insufficiency Moderate | Renal Insufficiency Severe | Kidney Failure, Chronic | Creatinine clearance measurement Creatinine-based formula (CKD-EPI) Ideal Body Weight Based

Datentyp

boolean

Alias
UMLS CUI [1]
C3258293
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0022661
UMLS CUI [5,1]
C0373595
UMLS CUI [5,2]
C2964649
UMLS CUI [5,3]
C0421272
UMLS CUI [5,4]
C1705938
5. severe hepatic impairment
Beschreibung

Hepatic impairment Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205082
6. use of other products intended for weight loss including prescription drugs, over-the-counter (otc) drugs, and herbal preparations
Beschreibung

Weight-Loss Agents | Prescription Drugs | Drugs, Non-Prescription | Plant Preparations

Datentyp

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2]
C0304227
UMLS CUI [3]
C0013231
UMLS CUI [4]
C0949854
7. use of more than one other serotonergic drug
Beschreibung

Serotonin Agents Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242701
UMLS CUI [1,2]
C1265611
8. use of drugs known to increase the risk for cardiac valvulopathy prior to screening including, but not limited to: cyproheptadine, amoxapine, tcas, mirtazapine, pergolide, ergotamine, methysergide, cabergoline
Beschreibung

Pharmaceutical Preparations At risk Heart valve disease | Cyproheptadine | Amoxapine | Tricyclic Antidepressive Agents | Mirtazapine | Pergolide | Ergotamine | Methysergide | cabergoline

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0018824
UMLS CUI [2]
C0010620
UMLS CUI [3]
C0002644
UMLS CUI [4]
C0003290
UMLS CUI [5]
C0049506
UMLS CUI [6]
C0031007
UMLS CUI [7]
C0014710
UMLS CUI [8]
C0025842
UMLS CUI [9]
C0107994
9. history or evidence of clinically significant disease (e.g., malignancy, cardiac, respiratory, gastrointestinal, renal or psychiatric disease)
Beschreibung

Disease Clinical Significance | Malignant Neoplasms | Heart Diseases | Respiration Disorders | Gastrointestinal Diseases | Kidney Diseases | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0035204
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0004936
10. use of lorcaserin hcl prior to screening or hypersensitivity to lorcaserin hcl or any of the excipients
Beschreibung

lorcaserin hydrochloride | Hypersensitivity Lorcaserin hydrochloride | Hypersensitivity Lorcaserin hydrochloride Excipient

Datentyp

boolean

Alias
UMLS CUI [1]
C2697942
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2697942
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2697942
UMLS CUI [3,3]
C0015237
11. planned bariatric surgery
Beschreibung

Bariatric Surgery Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1456587
UMLS CUI [1,2]
C1301732
12. females must not be breastfeeding or pregnant
Beschreibung

Breast Feeding | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
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Ähnliche Modelle

Eligibility Cardiovascular Disease NCT02019264

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
1. bmi greater than or equal to 27 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Compliance behavior Low-Calorie Diet | Compliance behavior Increased physical activity levels
Item
2. subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program
boolean
C1321605 (UMLS CUI [1,1])
C2930544 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0851792 (UMLS CUI [2,2])
Age | Cardiovascular Disease
Item
3. age greater than or equal to 40 years with established cv disease as defined by one of the following:
boolean
C0001779 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
Myocardial Infarction | Ischemic stroke
Item
1. history of documented mi or ischemic stroke
boolean
C0027051 (UMLS CUI [1])
C0948008 (UMLS CUI [2])
Peripheral Arterial Disease
Item
2. history of peripheral artery disease
boolean
C1704436 (UMLS CUI [1])
Coronary revascularisation | Carotid revascularisation | Peripheral revascularisation
Item
3. history of revascularization (coronary, carotid, or peripheral artery)
boolean
C0877341 (UMLS CUI [1])
C3495793 (UMLS CUI [2])
C1096418 (UMLS CUI [3])
Coronary Stenosis | Revascularization Absent
Item
4. significant unrevascularized coronary arterial stenosis
boolean
C0242231 (UMLS CUI [1])
C0581603 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Age | Gender | Diabetes Mellitus, Non-Insulin-Dependent | Cardiovascular Disease Absent | Cardiovascular risk factor Quantity
Item
age greater than or equal to 55 years for women or greater than or equal to 50 years for men who have t2dm without established cv disease plus at least one of the following cv risk factors:
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
C0007222 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0850624 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Hypertensive disease | Therapeutic procedure Hypertensive disease
Item
1. hypertension, or currently receiving therapy for documented hypertension
boolean
C0020538 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0020538 (UMLS CUI [2,2])
Dyslipidemia | Lipid-lowering therapy Dyslipidemia
Item
2. dyslipidemia, or currently taking prescription lipid-lowering therapy for documented dyslipidemia
boolean
C0242339 (UMLS CUI [1])
C0585943 (UMLS CUI [2,1])
C0242339 (UMLS CUI [2,2])
Creatinine clearance measurement Creatinine-based formula (CKD-EPI)
Item
3. calculated creatinine clearance greater than or equal to 30 to less than or equal to 60 ml/min per the chronic kidney disease epidemiology collaboration (ckd-epi) equation
boolean
C0373595 (UMLS CUI [1,1])
C2964649 (UMLS CUI [1,2])
High-sensitivity C-reactive protein increased
Item
4. high hscrp
boolean
C1963867 (UMLS CUI [1])
Urine albumin/creatinine ratio measurement
Item
5. urinary albumin-to-creatinine ratio (acr) greater than or equal to 30 ug/mg
boolean
C0455271 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Pre-existing | Non-Insulin-Dependent Diabetes Mellitus Newly Diagnosed
Item
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.
boolean
C0011860 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Antidiabetics | Therapeutic procedure Stable Non-Insulin-Dependent Diabetes Mellitus
Item
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.
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0011860 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Moderate signs/symptoms Congestive heart failure New York Heart Association Classification | Symptom severe Congestive heart failure New York Heart Association Classification
Item
1. moderate or greater symptoms of congestive cardiac failure (new york heart association [nyha] class iii or iv)
boolean
C3846034 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0436345 (UMLS CUI [2,1])
C0018802 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
Left ventricular ejection fraction
Item
2. known left ventricular (lv) ejection fraction less than 20%
boolean
C0428772 (UMLS CUI [1])
Moderate signs/symptoms Pulmonary Hypertension | Symptom severe Pulmonary Hypertension
Item
3. moderate or greater symptoms of pulmonary hypertension (ph)
boolean
C3846034 (UMLS CUI [1,1])
C0020542 (UMLS CUI [1,2])
C0436345 (UMLS CUI [2,1])
C0020542 (UMLS CUI [2,2])
Valvular disease | Renal Insufficiency Moderate | Renal Insufficiency Severe | Kidney Failure, Chronic | Creatinine clearance measurement Creatinine-based formula (CKD-EPI) Ideal Body Weight Based
Item
4. known severe valvular disease moderate renal impairment, severe renal impairment, or end stage renal disease (esrd) (calculated creatinine clearance less than 30 ml/min per the ckd-epi equation based on ideal body weight)
boolean
C3258293 (UMLS CUI [1])
C1565489 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C1565489 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0022661 (UMLS CUI [4])
C0373595 (UMLS CUI [5,1])
C2964649 (UMLS CUI [5,2])
C0421272 (UMLS CUI [5,3])
C1705938 (UMLS CUI [5,4])
Hepatic impairment Severe
Item
5. severe hepatic impairment
boolean
C0948807 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Weight-Loss Agents | Prescription Drugs | Drugs, Non-Prescription | Plant Preparations
Item
6. use of other products intended for weight loss including prescription drugs, over-the-counter (otc) drugs, and herbal preparations
boolean
C0376606 (UMLS CUI [1])
C0304227 (UMLS CUI [2])
C0013231 (UMLS CUI [3])
C0949854 (UMLS CUI [4])
Serotonin Agents Quantity
Item
7. use of more than one other serotonergic drug
boolean
C0242701 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Pharmaceutical Preparations At risk Heart valve disease | Cyproheptadine | Amoxapine | Tricyclic Antidepressive Agents | Mirtazapine | Pergolide | Ergotamine | Methysergide | cabergoline
Item
8. use of drugs known to increase the risk for cardiac valvulopathy prior to screening including, but not limited to: cyproheptadine, amoxapine, tcas, mirtazapine, pergolide, ergotamine, methysergide, cabergoline
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0018824 (UMLS CUI [1,3])
C0010620 (UMLS CUI [2])
C0002644 (UMLS CUI [3])
C0003290 (UMLS CUI [4])
C0049506 (UMLS CUI [5])
C0031007 (UMLS CUI [6])
C0014710 (UMLS CUI [7])
C0025842 (UMLS CUI [8])
C0107994 (UMLS CUI [9])
Disease Clinical Significance | Malignant Neoplasms | Heart Diseases | Respiration Disorders | Gastrointestinal Diseases | Kidney Diseases | Mental disorders
Item
9. history or evidence of clinically significant disease (e.g., malignancy, cardiac, respiratory, gastrointestinal, renal or psychiatric disease)
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
lorcaserin hydrochloride | Hypersensitivity Lorcaserin hydrochloride | Hypersensitivity Lorcaserin hydrochloride Excipient
Item
10. use of lorcaserin hcl prior to screening or hypersensitivity to lorcaserin hcl or any of the excipients
boolean
C2697942 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C2697942 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2697942 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
Bariatric Surgery Planned
Item
11. planned bariatric surgery
boolean
C1456587 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
12. females must not be breastfeeding or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
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