Informações:
Falhas:
ID
34141
Descrição
Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103; ODM derived from: https://clinicaltrials.gov/show/NCT02390258
Link
https://clinicaltrials.gov/show/NCT02390258
Palavras-chave
Versões (1)
- 14/01/2019 14/01/2019 -
Titular dos direitos
see on clinicaltrials.gov
Transferido a
14 de janeiro de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02390258
Eligibility Atrial Fibrillation NCT02390258
- StudyEvent: Eligibility
Similar models
Eligibility Atrial Fibrillation NCT02390258
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
ID.1
Item
for parts 1 and 3 healthy, male subjects aged 18 to 45 years, inclusive. for part 2 healthy, male and female subjects aged 45 to 65 years, inclusive.
boolean
ID.2
Item
females must be of non-childbearing potential
boolean
ID.3
Item
subject has a known heart disease.
boolean
ID.4
Item
subject has any of qtcf > 450 msec, pr ≥ 210 msec or qrs ≥ 120 msec at screening (determined from median of three readings).
boolean
ID.5
Item
for part 1 only: subject has resting heart rate outside of the range 45 to 80 beats per minute (bpm) at screening (determined from median of three readings).
boolean
ID.6
Item
subject has any other condition which, in the investigator's opinion will interfere with the trial.
boolean
ID.7
Item
subject has a systolic blood pressure (bp) <80 or >160 mmhg at screening or a diastolic bp >90 or <45 mmhg at screening.
boolean
ID.8
Item
subject has a clinically significant abnormal laboratory test result at screening.
boolean
ID.9
Item
female subject who is pregnant or breast feeding and female subjects of childbearing potential.
boolean