ID
38144
Beschreibung
Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder
Stichworte
Versionen (2)
- 22.09.19 22.09.19 -
- 24.10.19 24.10.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
22. September 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363
Screening
- StudyEvent: ODM
Beschreibung
Date of Visit/Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Beschreibung
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Patient date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Childbearing Potential
Datentyp
text
Alias
- UMLS CUI [1]
- C3831118
Beschreibung
Ethnic group
Datentyp
text
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Your ancestry or national origin
Datentyp
text
Alias
- UMLS CUI [1]
- C3841890
Beschreibung
Pharmacogenetic (PGx) Research Consent / Blood Sample Collection
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C0005834
Beschreibung
Pharmacogenetic Test, Informed Consent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
Beschreibung
Pharmacogenetic Test, Informed Consent, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0011008
Beschreibung
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0005834
Beschreibung
Pharmacogenetic Test, Informed Consent, Reason and justification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Beschreibung
Pharmacogenetic Test, Informed Consent, Reason and justification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Beschreibung
Pharmacogenetic (PGx) Research Withdrawal of Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C2349954
Beschreibung
Pharmacogenetic Test, Informed Consent, Withdraw
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Beschreibung
Pharmacogenetic Test, Informed Consent, Withdraw, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
- UMLS CUI [1,4]
- C0011008
Beschreibung
Pharmacogenetic Test, Blood specimen, Destruction, Request
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
Beschreibung
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
- UMLS CUI [1,5]
- C0566251
Beschreibung
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
- UMLS CUI [1,5]
- C0566251
Beschreibung
Screen Failure
Alias
- UMLS CUI-1
- C1710476
Beschreibung
Trial Screen Failure
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1710476
Beschreibung
Trial Screen Failure, Reason and justification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Beschreibung
Trial Screen Failure, Reason and justification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Beschreibung
Trial Screen Failure, Clinical Study Case, Investigator Signature
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C1706256
- UMLS CUI [1,4]
- C2346576
Beschreibung
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Beschreibung
Eligibility Determination
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013893
Beschreibung
Inclusion
Datentyp
text
Alias
- UMLS CUI [1]
- C1512693
Beschreibung
Exclusion Criteria
Datentyp
text
Alias
- UMLS CUI [1]
- C0680251
Beschreibung
Status of Medications
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Concomitant Agent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Concomitant Agent, Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Beschreibung
Concomitant Agent, Medication name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschreibung
Concomitant Agent, Medication name, Reported Term
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [1,3]
- C2826302
Beschreibung
Concomitant Agent, Pharmaceutical Preparations, Synonym
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0871468
Beschreibung
Concomitant Agent, Code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
Beschreibung
Concomitant Agent, Code, Failed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Beschreibung
Concomitant Agent, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0011008
Beschreibung
Concomitant Agent, Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0040223
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Body Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Body Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Body mass index
Datentyp
float
Maßeinheiten
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
Systolic Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Systolic Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Systolic Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Systolic Pressure, Low, Average
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Beschreibung
Diastolic blood pressure, Low, Average
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
12 lead ECG, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beschreibung
12 lead ECG, Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Beschreibung
12 lead ECG, P-R Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beschreibung
12 lead ECG, QRS complex duration
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beschreibung
12 lead ECG, QT Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beschreibung
12 lead ECG, Electrocardiogram QT corrected interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beschreibung
12 lead ECG, Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beschreibung
12 lead ECG, QRS Axis
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429012
Beschreibung
12 lead ECG, RR interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0489636
Beschreibung
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
Clinical Study Case, Investigator Signature
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C2346576
Beschreibung
Clinical Study Case, Investigator Signature
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C2346576
Ähnliche Modelle
Screening
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C0021430 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C1706256 (UMLS CUI [1,3])
C2346576 (UMLS CUI [1,4])
C2348184 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C0429012 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])