ID
44874
Beschreibung
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Screening
Stichworte
Versionen (3)
- 10.08.16 10.08.16 -
- 28.09.16 28.09.16 -
- 18.02.22 18.02.22 - Martin Dugas
Rechteinhaber
Astellas Pharma Inc
Hochgeladen am
18. Februar 2022
DOI
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Lizenz
Creative Commons BY-NC 4.0
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Screening Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
Screening Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
- StudyEvent: ODM
Beschreibung
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
Eligibility, Inclusion Criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C0013893
Beschreibung
Informed Consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Age | Gender
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C0079399
Beschreibung
Type 2 Diabetes Mellitus
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011860
Beschreibung
HbA1c
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019018
Beschreibung
Diabetes mellitus Medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0948092
Beschreibung
Diet | Exercise
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0012155
- UMLS CUI [2]
- C0015259
Beschreibung
BMI
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
Pregnancy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Eligibility, Exclusion
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C0013893
Beschreibung
Complication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009566
Beschreibung
Type 1 Diabetes mellitus
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011854
Beschreibung
insulin
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021641
Beschreibung
creatinine
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
ALT | AST | Bilirubin
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0201836
- UMLS CUI [2]
- C0201899
- UMLS CUI [3]
- C1278039
Beschreibung
microalbumin, creatinine
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2362049
- UMLS CUI [2]
- C0201976
Beschreibung
urinary tract infection | genital infection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042029
- UMLS CUI [2]
- C0729552
Beschreibung
hypertension
Datentyp
text
Alias
- UMLS CUI [1]
- C0020538
Beschreibung
cardiovascular disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0007222
Beschreibung
Hepatitis | HIV
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019158
- UMLS CUI [2]
- C0019682
Beschreibung
medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
lactic acidosis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001125
Beschreibung
drug abuse | alcohol abuse
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013146
- UMLS CUI [2]
- C0085762
Beschreibung
malignancy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0006826
Beschreibung
lactating
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2828358
Beschreibung
mental ilness
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004936
Beschreibung
hypersensitivity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0020517
Beschreibung
ASP1941
Datentyp
boolean
Beschreibung
Drug study
Datentyp
boolean
Beschreibung
illness
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0221423
Beschreibung
Eligibility
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013893
Beschreibung
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschreibung
Sex
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Age
Datentyp
integer
Maßeinheiten
- years
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
Race
Datentyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Race, Other
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Ethnicity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Primary Diagnosis
Alias
- UMLS CUI-1
- C0332137
Beschreibung
Subject Characteristics
Alias
- UMLS CUI-1
- C1706465
Beschreibung
Sexually active
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0241028
Beschreibung
Circumcision
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0008819
Beschreibung
Vascular Disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C1881056
Beschreibung
Date of Visit
Alias
- UMLS CUI-1
- C1320303
Beschreibung
Tobacco History
Alias
- UMLS CUI-1
- C1519384
Beschreibung
Tobacco History
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519384
Beschreibung
Tobacco type
Datentyp
integer
Alias
- UMLS CUI [1]
- C3166496
Beschreibung
Tobacco quantity
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0040329
- UMLS CUI [1,2]
- C1265611
Beschreibung
Alcohol History
Alias
- UMLS CUI-1
- C0085762
Beschreibung
Alcohol History
Datentyp
integer
Alias
- UMLS CUI [1]
- C0085762
Beschreibung
Alcohol quantity
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0001962
- UMLS CUI [1,2]
- C1265611
Beschreibung
Urinary Tract Infection History
Alias
- UMLS CUI-1
- C0042029
Beschreibung
Diagnosis | Urinary Tract Infection
Datentyp
integer
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0042029
Beschreibung
History of Urinary Tract Infection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019664
- UMLS CUI [2]
- C0042029
Beschreibung
Urinary Tract Infection Occurrence
Datentyp
text
Alias
- UMLS CUI [1]
- C0042029
- UMLS CUI [2]
- C2745955
Beschreibung
Site of Infection
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0475264
Beschreibung
Organism
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0029235
Beschreibung
Organism Lab
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0029235
Beschreibung
Onset Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0574845
Beschreibung
Ongoing
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0549178
Beschreibung
Recovery
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C2004454
Beschreibung
Symptomatic
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0231220
Beschreibung
Treatment
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0087111
Beschreibung
Genital Infection History
Alias
- UMLS CUI-1
- C0729552
Beschreibung
Diagnosis
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0729552
Beschreibung
History
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C2745955
Beschreibung
Occurence
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C2745955
Beschreibung
Site of Infection
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0475264
- UMLS CUI [1,2]
- C0729552
Beschreibung
Organism
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0029235
Beschreibung
Confirmation
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0029235
Beschreibung
Onset Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0574845
Beschreibung
Medical Condition Ongoing
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0549178
Beschreibung
Recovery
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C2004454
Beschreibung
Symptomatic
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0231220
Beschreibung
Treatment
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0087111
Beschreibung
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Physical Examination
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Assessment Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C2985720
Beschreibung
Orthostatic vital signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Assessment
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
Beschreibung
Assessment Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
- UMLS CUI [1,3]
- C2985720
Beschreibung
Assessment Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
- UMLS CUI [1,3]
- C0040223
Beschreibung
Vital Signs
Datentyp
integer
Alias
- UMLS CUI [1]
- C0518766
Beschreibung
Location of blood pressure measurement
Datentyp
integer
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Systolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Pulse Rate
Datentyp
integer
Maßeinheiten
- Beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
12 Lead ECG 1
Alias
- UMLS CUI-1
- C0013798
Beschreibung
ECG Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0011008
Beschreibung
ECG time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Beschreibung
ECG Interpretation
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Beschreibung
Height and Weight
Alias
- UMLS CUI-1
- C0005890
- UMLS CUI-3
- C0005910
Beschreibung
Assessment Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
BMI
Datentyp
float
Maßeinheiten
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
Previous Diabetes Medication Use
Alias
- UMLS CUI-1
- C0011849
Beschreibung
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Beschreibung
Potential childbearing
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3831118
Beschreibung
Reason Pregnancy Test Not Done
Datentyp
integer
Alias
- UMLS CUI [1]
- C0032976
Beschreibung
Urine Sample
Datentyp
integer
Alias
- UMLS CUI [1]
- C0200354
Beschreibung
Pregnancy Test: Date
Datentyp
date
Maßeinheiten
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschreibung
Pregnancy test
Datentyp
text
Alias
- UMLS CUI [1]
- C0427777
Ähnliche Modelle
Screening Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
- StudyEvent: ODM
C0013893 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0015259 (UMLS CUI [2])
C0013893 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201976 (UMLS CUI [2])
C0729552 (UMLS CUI [2])
C0019682 (UMLS CUI [2])
C0085762 (UMLS CUI [2])
C1881056 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
C1265611 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
C1265611 (UMLS CUI [1,2])
C0042029 (UMLS CUI [2])
C0042029 (UMLS CUI [2])
C2745955 (UMLS CUI [2])
C0475264 (UMLS CUI [1,2])
C0029235 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C2004454 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
C0729552 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C2004454 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,2])
(Comment:en)
C2985739 (UMLS CUI-2)
C1518422 (UMLS CUI-3)
(Comment:en)
C2985739 (UMLS CUI-2)
(Comment:en)
C0011008 (UMLS CUI [1,2])