ID
38536
Beskrivning
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders
Nyckelord
Versioner (2)
- 2019-09-22 2019-09-22 -
- 2019-10-24 2019-10-24 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
24 oktober 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636
Screening
- StudyEvent: ODM
Beskrivning
Date of Visit/Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Beskrivning
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Beskrivning
Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Patient date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Gender
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Childbearing Potential
Datatyp
text
Alias
- UMLS CUI [1]
- C3831118
Beskrivning
Ethnic group
Datatyp
text
Alias
- UMLS CUI [1]
- C0015031
Beskrivning
Your ancestry or national origin
Datatyp
text
Alias
- UMLS CUI [1]
- C3841890
Beskrivning
Pharmacogenetic (PGx) Research Consent / Blood Sample Collection
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C0005834
Beskrivning
Pharmacogenetic Test, Informed Consent
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
Beskrivning
Pharmacogenetic Test, Informed Consent, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0011008
Beskrivning
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0005834
Beskrivning
Pharmacogenetic Test, Informed Consent, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Beskrivning
Pharmacogenetic Test, Informed Consent, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Beskrivning
Pharmacogenetic (PGx) Research Withdrawal of Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C2349954
Beskrivning
Pharmacogenetic Test, Informed Consent, Withdraw
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Beskrivning
Pharmacogenetic Test, Informed Consent, Withdraw, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
- UMLS CUI [1,4]
- C0011008
Beskrivning
Pharmacogenetic Test, Blood specimen, Destruction, Request
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
Beskrivning
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Datatyp
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
Beskrivning
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Datatyp
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
Beskrivning
Screen Failure
Alias
- UMLS CUI-1
- C1710476
Beskrivning
Trial Screen Failure
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1710476
Beskrivning
Trial Screen Failure, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Beskrivning
Trial Screen Failure, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Beskrivning
Trial Screen Failure, Clinical Study Case, Investigator Signature
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C1706256
- UMLS CUI [1,4]
- C2346576
Beskrivning
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Beskrivning
Eligibility Determination
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013893
Beskrivning
Inclusion
Datatyp
text
Alias
- UMLS CUI [1]
- C1512693
Beskrivning
Exclusion Criteria
Datatyp
text
Alias
- UMLS CUI [1]
- C0680251
Beskrivning
Status of Medications
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Concomitant Agent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Concomitant Agent, Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Beskrivning
Concomitant Agent, Medication name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beskrivning
Concomitant Agent, Medication name, Reported Term
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [1,3]
- C2826302
Beskrivning
Concomitant Agent, Pharmaceutical Preparations, Synonym
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0871468
Beskrivning
Concomitant Agent, Code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
Beskrivning
Concomitant Agent, Code, Failed
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Beskrivning
Concomitant Agent, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0011008
Beskrivning
Concomitant Agent, Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0040223
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Body Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Body Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Body mass index
Datatyp
float
Måttenheter
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beskrivning
Systolic Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Systolic Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Systolic Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Systolic Pressure, Low, Average
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Beskrivning
Diastolic blood pressure, Low, Average
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Beskrivning
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beskrivning
12 lead ECG, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beskrivning
12 lead ECG, Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Beskrivning
12 lead ECG, P-R Interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beskrivning
12 lead ECG, QRS complex duration
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beskrivning
12 lead ECG, QT Interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beskrivning
12 lead ECG, Electrocardiogram QT corrected interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beskrivning
12 lead ECG, Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beskrivning
12 lead ECG, QRS Axis
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429012
Beskrivning
12 lead ECG, RR interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0489636
Beskrivning
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
Clinical Study Case, Investigator Signature
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C2346576
Beskrivning
Clinical Study Case, Investigator Signature
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C2346576
Similar models
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])