Information:
Fel:
ID
12762
Beskrivning
Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01213368
Länk
https://clinicaltrials.gov/show/NCT01213368
Nyckelord
Versioner (1)
- 2015-12-21 2015-12-21 -
Uppladdad den
21 december 2015
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01213368
Eligibility Atrial Fibrillation NCT01213368
- StudyEvent: Eligibility
Similar models
Eligibility Atrial Fibrillation NCT01213368
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
age
Item
patients of aged 20 years or more.
boolean
C0001779 (UMLS CUI [1])
atrial fibrillation permanent; ventricular heart rate resting
Item
permanent atrial fibrillation [af] (defined as duration of af > 6 months) for which cardioversion is not considered and with resting ventricular heart rate ≥ 80 bpm at screening.
boolean
C0004238 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C1883530 (UMLS CUI [2,1])
C0679218 (UMLS CUI [2,2])
C0205355 (UMLS CUI [1,2])
C1883530 (UMLS CUI [2,1])
C0679218 (UMLS CUI [2,2])
unstable angina pectoris
Item
unstable angina pectoris.
boolean
C0002965 (UMLS CUI [1])
torsades de pointes
Item
history of torsades de pointes.
boolean
C0040479 (UMLS CUI [1])
Prolonged QTc
Item
prolonged qt corrected interval (≥ 500 ms).
boolean
C0151878 (UMLS CUI [1])
atrioventricular block; pacemaker implantation permanent
Item
third degree atrioventricular block (avb) on the screening ecg while in af or, documentation on previous ecgs while in sinus rhythm of pr-interval > 0.28 sec or high degree avb (2nd degree or higher) or, significant sinus node disease (documented pause ≥ 3 sec) - without a permanent pacemaker implanted.
boolean
C0004245 (UMLS CUI [1])
C0189842 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
C0189842 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
congestive heart failure; new york heart association classification
Item
congestive heart failure (chf) of new york heart association classification (nyha) class iv or recent (within 1 month prior to randomization) unstable nyha class iii.
boolean
C0018802 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C1275491 (UMLS CUI [2])
anti-arrhythmic drugs
Item
treatment with other class i or iii anti-arrhythmic drugs.
boolean
C0003195 (UMLS CUI [1])
amiodarone
Item
patients treated with amiodarone during the 4 weeks preceding randomization.
boolean
C0002598 (UMLS CUI [1])
Comorbidity
Item
clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic (in particular thyroid) or psychiatric disease.
boolean
C0009488 (UMLS CUI [1])
hypokalemia; hypomagnesemia
Item
hypokalemia and hypomagnesemia must be corrected before randomization.
boolean
C0020621 (UMLS CUI [1])
C0151723 (UMLS CUI [2])
C0151723 (UMLS CUI [2])
informed consent
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C0021430 (UMLS CUI [1])