ID

43795

Description

Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00979316

Link

https://clinicaltrials.gov/show/NCT00979316

Keywords

Versions (2)
  1. 5/1/16 5/1/16 -
  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 Alzheimer Disease NCT00979316

English

Eligibility Alzheimer Disease NCT00979316

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index (bmi) of 18 to 32 kg/m², inclusive.
Description

body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
Description

contraception status postmenopausal

Data type

boolean

Alias
UMLS CUI [1,1]
C0420837
UMLS CUI [1,2]
C0232970
healthy subjects
Description

health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
Description

cardiac arrhythmias; presyncope; syncope

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2]
C0700200
UMLS CUI [3]
C0039070
sexually active fertile men not using effective birth control (double barrier) if their partners are wocbp
Description

men sexually active fertile; birth control

Data type

boolean

Alias
UMLS CUI [1,1]
C0025266
UMLS CUI [1,2]
C0036899
UMLS CUI [1,3]
C2703065
women who are pregnant or breastfeeding
Description

pregnancy; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
Description

hypersensitivity moxifloxacin Microbicides

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0536495
UMLS CUI [1,3]
C1136254
history of hypokalemia, history or family history of prolonged qt interval, or family history of sudden cardiac death at a young age
Description

hypokalemia; prolonged qt interval; sudden cardiac death

Data type

boolean

Alias
UMLS CUI [1]
C0020621
UMLS CUI [2]
C0151878
UMLS CUI [3]
C0085298
any clinically significant ecg abnormality
Description

ecg abnormality

Data type

boolean

Alias
UMLS CUI [1]
C0522055
history of seizure disorders
Description

seizure

Data type

boolean

Alias
UMLS CUI [1]
C0036572
history of drowning survival
Description

drowning

Data type

boolean

Alias
UMLS CUI [1]
C0013142
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Similar models

Eligibility Alzheimer Disease NCT00979316

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
body mass index
Item
body mass index (bmi) of 18 to 32 kg/m², inclusive.
boolean
C1305855 (UMLS CUI [1])
contraception status postmenopausal
Item
women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
boolean
C0420837 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
health status
Item
healthy subjects
boolean
C0018759 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cardiac arrhythmias; presyncope; syncope
Item
history of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
boolean
C0003811 (UMLS CUI [1])
C0700200 (UMLS CUI [2])
C0039070 (UMLS CUI [3])
men sexually active fertile; birth control
Item
sexually active fertile men not using effective birth control (double barrier) if their partners are wocbp
boolean
C0025266 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C2703065 (UMLS CUI [1,3])
pregnancy; lactating
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hypersensitivity moxifloxacin Microbicides
Item
history of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
boolean
C0020517 (UMLS CUI [1,1])
C0536495 (UMLS CUI [1,2])
C1136254 (UMLS CUI [1,3])
hypokalemia; prolonged qt interval; sudden cardiac death
Item
history of hypokalemia, history or family history of prolonged qt interval, or family history of sudden cardiac death at a young age
boolean
C0020621 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
C0085298 (UMLS CUI [3])
ecg abnormality
Item
any clinically significant ecg abnormality
boolean
C0522055 (UMLS CUI [1])
seizure
Item
history of seizure disorders
boolean
C0036572 (UMLS CUI [1])
drowning
Item
history of drowning survival
boolean
C0013142 (UMLS CUI [1])
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