ID

12753

Descripción

A Drug Interaction Study of Simvastatin and Albiglutide; ODM derived from: https://clinicaltrials.gov/show/NCT01147692

Link

https://clinicaltrials.gov/show/NCT01147692

Palabras clave

Versiones (1)
  1. 21/12/15 21/12/15 -
Subido en

21 de diciembre de 2015

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01147692

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT01147692

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
no clinically significant diseases or clinically significant abnormal laboratory values
Descripción

diseases; Laboratory Results normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C1254595
UMLS CUI [2,2]
C0205307
females must be of non-childbearing potential
Descripción

pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0549206
body mass index (bmi) is >/=18 kg and ≤30 kg/m2
Descripción

ID.3

Tipo de datos

boolean

nonsmoker
Descripción

nonsmoker

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0337672
negative drug screen
Descripción

negative drug screen

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0919819
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive test results for hepatitis b, hepatitis c or human immunodeficiency virus (hiv)
Descripción

Hepatitis B test positive;HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1608966
UMLS CUI [2]
C0019699
any clinically relevant abnormality
Descripción

comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
female subject is pregnant or breast-feeding
Descripción

pregnancy; lactating

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of any anaphylactic reaction to any drug
Descripción

hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020517
history of significant cardiovascular or pulmonary dysfunction
Descripción

cardiovascular disease; pulmonary disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0024115
current or chronic history of liver disease
Descripción

liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085605
history of alcohol or substance abuse
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
history of thyroid dysfunction or disease
Descripción

thyroid disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040128
history of gastrointestinal surgery or disease
Descripción

surgery gastrointestinal; disease gastrointestinal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038894
UMLS CUI [1,2]
C0521362
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521362
history of pancreatitis
Descripción

pancreatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030305
previously received any glp-1 mimetic compound (e.g., exenatide)
Descripción

exenatide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0167117
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01147692

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
diseases; Laboratory Results normal
Item
no clinically significant diseases or clinically significant abnormal laboratory values
boolean
C0012634 (UMLS CUI [1])
C1254595 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
pregnancy
Item
females must be of non-childbearing potential
boolean
C0549206 (UMLS CUI [1])
ID.3
Item
body mass index (bmi) is >/=18 kg and ≤30 kg/m2
boolean
nonsmoker
Item
nonsmoker
boolean
C0337672 (UMLS CUI [1])
negative drug screen
Item
negative drug screen
boolean
C0919819 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hepatitis B test positive;HIV Seropositivity
Item
positive test results for hepatitis b, hepatitis c or human immunodeficiency virus (hiv)
boolean
C1608966 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
comorbidity
Item
any clinically relevant abnormality
boolean
C0009488 (UMLS CUI [1])
pregnancy; lactating
Item
female subject is pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hypersensitivity
Item
history of any anaphylactic reaction to any drug
boolean
C0020517 (UMLS CUI [1])
cardiovascular disease; pulmonary disease
Item
history of significant cardiovascular or pulmonary dysfunction
boolean
C0007222 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
liver disease
Item
current or chronic history of liver disease
boolean
C0085605 (UMLS CUI [1])
Substance Use Disorders
Item
history of alcohol or substance abuse
boolean
C0038586 (UMLS CUI [1])
thyroid disease
Item
history of thyroid dysfunction or disease
boolean
C0040128 (UMLS CUI [1])
surgery gastrointestinal; disease gastrointestinal
Item
history of gastrointestinal surgery or disease
boolean
C0038894 (UMLS CUI [1,1])
C0521362 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0521362 (UMLS CUI [2,2])
pancreatitis
Item
history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
exenatide
Item
previously received any glp-1 mimetic compound (e.g., exenatide)
boolean
C0167117 (UMLS CUI [1])
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