ID
38536
Beschreibung
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
Stichworte
Versionen (2)
- 22.09.19 22.09.19 -
- 24.10.19 24.10.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. Oktober 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636
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])