ID
29023
Beskrivning
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder
Nyckelord
Versioner (1)
- 2018-02-21 2018-02-21 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
21 februari 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder 101497
Visit 2 (Baseline)
- StudyEvent: ODM
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Height is recorded in cm. The following conversion factor must be used : inches x 2.54 = height in cm. Height is recorded to the nearest 1/2 cm.
Datatyp
float
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Weight is recorded in kg - see conversion table for lbs to kg. Weight is recorded to the nearest 1/10 kg.
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Blood Pressure Systolic
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Baseline Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beskrivning
If 'Yes', please record on the Current Medical Conditions or Adverse Events panel as appropriate. NOTE: At the Baseline Visit, only serious adverse events related to study procedures must be recorded on the Adverse Events panel. All other adverse events at the Baseline visit should be recorded on the Current Medical Conditions panel.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Concomitant Medication Prompt
Alias
- UMLS CUI-1
- C2347852
Beskrivning
If 'Yes', please record on the Prior and Concomitant Medications panel. Saving this panel after selecting 'Yes' will take you to the Prior and Concomitant Medications panel located in the Additional Forms section of the eCRF.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2169461
Beskrivning
Urine dipstick pregnancy test
Alias
- UMLS CUI-1
- C0430056
Beskrivning
Repeat 12-lead electrocardiogram prompt
Alias
- UMLS CUI-1
- C0013798
- UMLS CUI-2
- C0205341
Beskrivning
Repeat Laboratory tests
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0205341
Beskrivning
Baseline Inclusion Criteria
Beskrivning
If 'No', check all all boxes corresponding to violations of any of the Baseline Visit inclusion criteria.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1512693
Beskrivning
HAM-D score
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0451203
Beskrivning
CGI Severity of Illness score
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3639887
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
If 'Yes', check all boxes corresponding to the Baseline Visit exclusion criteria that disqualified the subject from entry
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0680251
Beskrivning
HAM-D total delta
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0451203
- UMLS CUI [1,2]
- C0439097
Beskrivning
Note: Subjects should not be withdrawn from their current treatment regimen for the primary purpose of enrolling into this study
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0033978
Beskrivning
systolic blood pressure | diastolic blood pressure
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C0428883
Beskrivning
Subject continuation prompt
Alias
- UMLS CUI-1
- C0805733
Beskrivning
----> If 'No', please complete the Study Conclusion panel and any outstanding data. ----> If 'Yes', please: - Randomise the subject into the study via the IVR system. - Dispense allocated study medication packs to the subject. - Complete the Randomisation Number panel. - Schedule Visit 3 for 7 days (+/- 3 days) time.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0805733
Beskrivning
randomisation number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
Visit 2 (Baseline)
- StudyEvent: ODM
C0449820 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
C1705241 (UMLS CUI [1,3])
C2169461 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0439097 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])