ID

43795

Beschreibung

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

Stichworte

  1. 01.05.16 01.05.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Alzheimer Disease NCT00979316

Eligibility Alzheimer Disease NCT00979316

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

body mass index

Datentyp

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
Beschreibung

contraception status postmenopausal

Datentyp

boolean

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

health status

Datentyp

boolean

Alias
UMLS CUI [1]
C0018759
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

cardiac arrhythmias; presyncope; syncope

Datentyp

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
Beschreibung

men sexually active fertile; birth control

Datentyp

boolean

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

pregnancy; lactating

Datentyp

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
Beschreibung

hypersensitivity moxifloxacin Microbicides

Datentyp

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
Beschreibung

hypokalemia; prolonged qt interval; sudden cardiac death

Datentyp

boolean

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

ecg abnormality

Datentyp

boolean

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

seizure

Datentyp

boolean

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

drowning

Datentyp

boolean

Alias
UMLS CUI [1]
C0013142

Ähnliche Modelle

Eligibility Alzheimer Disease NCT00979316

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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