ID

43665

Description

Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes; ODM derived from: https://clinicaltrials.gov/show/NCT00263042

Link

https://clinicaltrials.gov/show/NCT00263042

Keywords

Versions (2)
  1. 1/27/17 1/27/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00263042

English

Eligibility Cardiovascular Disease NCT00263042

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
waist circumference >102 cm (40 inches) males, >88 cm (35 inches) females, with one coronary heart disease (chd) equivalent or two major risk factors for cardiovascular disease.
Description

Waist Circumference | Gender | Coronary heart disease Equivalent | Risk factors Major Quantity Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0455829
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0010068
UMLS CUI [3,2]
C0205163
UMLS CUI [4,1]
C0035648
UMLS CUI [4,2]
C0205164
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0007222
chd equivalents:
Description

Coronary heart disease Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C0010068
UMLS CUI [1,2]
C0205163
recent (within 3 years)documented heart attack
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
documented symptomatic coronary artery disease
Description

Coronary Artery Disease Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0231220
recent (within 3 years) ischemic cerebrovascular episode (stroke or tia)
Description

Ischemic Cerebrovascular Accident | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0948008
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
documented symptomatic peripheral arterial disease
Description

Peripheral Arterial Disease Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1704436
UMLS CUI [1,2]
C0231220
major risk factors:
Description

Risk factors Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0205164
documented type 2 diabetes mellitus
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
metabolic syndrome (ncep criteria)
Description

Metabolic Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0524620
asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past abdominal aortic aneurysm repair
Description

Asymptomatic cerebrovascular disease | Kidney Disease Asymptomatic | Peripheral Arterial Disease Asymptomatic | Repair of aneurysm of abdominal aorta

Data type

boolean

Alias
UMLS CUI [1]
C0393970
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0231221
UMLS CUI [3,1]
C1704436
UMLS CUI [3,2]
C0231221
UMLS CUI [4]
C0741152
elevated high-sensitivity c-reactive protein
Description

High-sensitivity C-reactive protein increased

Data type

boolean

Alias
UMLS CUI [1]
C1963867
age > or = 65 years for males, age > or = 70 years for females
Description

Age | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
obesity of known endocrine origin
Description

Obesity of endocrine origin

Data type

boolean

Alias
UMLS CUI [1]
C0267992
pregnant or breastfeeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
very low calorie diet or weight loss surgery within past 6 months
Description

Very low energy diet | Bariatric Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0452268
UMLS CUI [2]
C1456587
presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation, including uncontrolled serious psychiatric illness
Description

Medical condition Severe Limiting Study Subject Participation Status | Mental condition Severe Limiting Study Subject Participation Status | Mental disorder Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C2348568
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0205318
likely cardiovascular intervention within next 1 month
Description

Interventional procedure Cardiovascular Probably

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C3887460
UMLS CUI [1,3]
C0750492
allergy to rimonabant or excipients, or prior participation in a rimonabant trial
Description

Hypersensitivity rimonabant | Hypersensitivity rimonabant Excipient | Study Subject Participation Status | Clinical Trial rimonabant

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1142933
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1142933
UMLS CUI [2,3]
C0015237
UMLS CUI [3]
C2348568
UMLS CUI [4,1]
C0008976
UMLS CUI [4,2]
C1142933
receipt of investigational product within past 30 days
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Cardiovascular Disease NCT00263042

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Waist Circumference | Gender | Coronary heart disease Equivalent | Risk factors Major Quantity Cardiovascular Disease
Item
waist circumference >102 cm (40 inches) males, >88 cm (35 inches) females, with one coronary heart disease (chd) equivalent or two major risk factors for cardiovascular disease.
boolean
C0455829 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0010068 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0035648 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0007222 (UMLS CUI [4,4])
Coronary heart disease Equivalent
Item
chd equivalents:
boolean
C0010068 (UMLS CUI [1,1])
C0205163 (UMLS CUI [1,2])
Myocardial Infarction
Item
recent (within 3 years)documented heart attack
boolean
C0027051 (UMLS CUI [1])
Coronary Artery Disease Symptomatic
Item
documented symptomatic coronary artery disease
boolean
C1956346 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Ischemic Cerebrovascular Accident | Cerebrovascular accident | Transient Ischemic Attack
Item
recent (within 3 years) ischemic cerebrovascular episode (stroke or tia)
boolean
C0948008 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Peripheral Arterial Disease Symptomatic
Item
documented symptomatic peripheral arterial disease
boolean
C1704436 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Risk factors Major
Item
major risk factors:
boolean
C0035648 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
documented type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Metabolic Syndrome
Item
metabolic syndrome (ncep criteria)
boolean
C0524620 (UMLS CUI [1])
Asymptomatic cerebrovascular disease | Kidney Disease Asymptomatic | Peripheral Arterial Disease Asymptomatic | Repair of aneurysm of abdominal aorta
Item
asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past abdominal aortic aneurysm repair
boolean
C0393970 (UMLS CUI [1])
C0022658 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C1704436 (UMLS CUI [3,1])
C0231221 (UMLS CUI [3,2])
C0741152 (UMLS CUI [4])
High-sensitivity C-reactive protein increased
Item
elevated high-sensitivity c-reactive protein
boolean
C1963867 (UMLS CUI [1])
Age | Gender
Item
age > or = 65 years for males, age > or = 70 years for females
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Obesity of endocrine origin
Item
obesity of known endocrine origin
boolean
C0267992 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Very low energy diet | Bariatric Surgery
Item
very low calorie diet or weight loss surgery within past 6 months
boolean
C0452268 (UMLS CUI [1])
C1456587 (UMLS CUI [2])
Medical condition Severe Limiting Study Subject Participation Status | Mental condition Severe Limiting Study Subject Participation Status | Mental disorder Serious Uncontrolled
Item
presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation, including uncontrolled serious psychiatric illness
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
Interventional procedure Cardiovascular Probably
Item
likely cardiovascular intervention within next 1 month
boolean
C0184661 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C0750492 (UMLS CUI [1,3])
Hypersensitivity rimonabant | Hypersensitivity rimonabant Excipient | Study Subject Participation Status | Clinical Trial rimonabant
Item
allergy to rimonabant or excipients, or prior participation in a rimonabant trial
boolean
C0020517 (UMLS CUI [1,1])
C1142933 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1142933 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C2348568 (UMLS CUI [3])
C0008976 (UMLS CUI [4,1])
C1142933 (UMLS CUI [4,2])
Investigational New Drugs
Item
receipt of investigational product within past 30 days
boolean
C0013230 (UMLS CUI [1])
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