ID
44874
Beschrijving
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
Trefwoorden
Versies (3)
- 10-08-16 10-08-16 -
- 28-09-16 28-09-16 -
- 18-02-22 18-02-22 - Martin Dugas
Houder van rechten
Astellas Pharma Inc
Geüploaded op
18 februari 2022
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Eligibility, Inclusion Criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C0013893
Beschrijving
Informed Consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Age | Gender
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C0079399
Beschrijving
Type 2 Diabetes Mellitus
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011860
Beschrijving
HbA1c
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019018
Beschrijving
Diabetes mellitus Medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C0948092
Beschrijving
Diet | Exercise
Datatype
boolean
Alias
- UMLS CUI [1]
- C0012155
- UMLS CUI [2]
- C0015259
Beschrijving
BMI
Datatype
boolean
Alias
- UMLS CUI [1]
- C1305855
Beschrijving
Pregnancy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Eligibility, Exclusion
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C0013893
Beschrijving
Complication
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009566
Beschrijving
Type 1 Diabetes mellitus
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011854
Beschrijving
insulin
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021641
Beschrijving
creatinine
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
ALT | AST | Bilirubin
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201836
- UMLS CUI [2]
- C0201899
- UMLS CUI [3]
- C1278039
Beschrijving
microalbumin, creatinine
Datatype
boolean
Alias
- UMLS CUI [1]
- C2362049
- UMLS CUI [2]
- C0201976
Beschrijving
urinary tract infection | genital infection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042029
- UMLS CUI [2]
- C0729552
Beschrijving
hypertension
Datatype
text
Alias
- UMLS CUI [1]
- C0020538
Beschrijving
cardiovascular disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0007222
Beschrijving
Hepatitis | HIV
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019158
- UMLS CUI [2]
- C0019682
Beschrijving
medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
lactic acidosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001125
Beschrijving
drug abuse | alcohol abuse
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013146
- UMLS CUI [2]
- C0085762
Beschrijving
malignancy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0006826
Beschrijving
lactating
Datatype
boolean
Alias
- UMLS CUI [1]
- C2828358
Beschrijving
mental ilness
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004936
Beschrijving
hypersensitivity
Datatype
boolean
Alias
- UMLS CUI [1]
- C0020517
Beschrijving
ASP1941
Datatype
boolean
Beschrijving
Drug study
Datatype
boolean
Beschrijving
illness
Datatype
boolean
Alias
- UMLS CUI [1]
- C0221423
Beschrijving
Eligibility
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013893
Beschrijving
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Age
Datatype
integer
Maateenheden
- years
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Race
Datatype
integer
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Race, Other
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Ethnicity
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Primary Diagnosis
Alias
- UMLS CUI-1
- C0332137
Beschrijving
Subject Characteristics
Alias
- UMLS CUI-1
- C1706465
Beschrijving
Sexually active
Datatype
boolean
Alias
- UMLS CUI [1]
- C0241028
Beschrijving
Circumcision
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008819
Beschrijving
Vascular Disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C1881056
Beschrijving
Date of Visit
Alias
- UMLS CUI-1
- C1320303
Beschrijving
Tobacco History
Alias
- UMLS CUI-1
- C1519384
Beschrijving
Tobacco History
Datatype
integer
Alias
- UMLS CUI [1]
- C1519384
Beschrijving
Tobacco type
Datatype
integer
Alias
- UMLS CUI [1]
- C3166496
Beschrijving
Tobacco quantity
Datatype
text
Alias
- UMLS CUI [1,1]
- C0040329
- UMLS CUI [1,2]
- C1265611
Beschrijving
Alcohol History
Alias
- UMLS CUI-1
- C0085762
Beschrijving
Alcohol History
Datatype
integer
Alias
- UMLS CUI [1]
- C0085762
Beschrijving
Alcohol quantity
Datatype
text
Alias
- UMLS CUI [1,1]
- C0001962
- UMLS CUI [1,2]
- C1265611
Beschrijving
Urinary Tract Infection History
Alias
- UMLS CUI-1
- C0042029
Beschrijving
Diagnosis | Urinary Tract Infection
Datatype
integer
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0042029
Beschrijving
History of Urinary Tract Infection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019664
- UMLS CUI [2]
- C0042029
Beschrijving
Urinary Tract Infection Occurrence
Datatype
text
Alias
- UMLS CUI [1]
- C0042029
- UMLS CUI [2]
- C2745955
Beschrijving
Site of Infection
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0475264
Beschrijving
Organism
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0029235
Beschrijving
Organism Lab
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0029235
Beschrijving
Onset Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0574845
Beschrijving
Ongoing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0549178
Beschrijving
Recovery
Datatype
date
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C2004454
Beschrijving
Symptomatic
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0231220
Beschrijving
Treatment
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0087111
Beschrijving
Genital Infection History
Alias
- UMLS CUI-1
- C0729552
Beschrijving
Diagnosis
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0729552
Beschrijving
History
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C2745955
Beschrijving
Occurence
Datatype
text
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C2745955
Beschrijving
Site of Infection
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0475264
- UMLS CUI [1,2]
- C0729552
Beschrijving
Organism
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0029235
Beschrijving
Confirmation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0029235
Beschrijving
Onset Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0574845
Beschrijving
Medical Condition Ongoing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0549178
Beschrijving
Recovery
Datatype
date
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C2004454
Beschrijving
Symptomatic
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0231220
Beschrijving
Treatment
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0087111
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Physical Examination
Datatype
boolean
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Assessment Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C2985720
Beschrijving
Orthostatic vital signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Assessment
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
Beschrijving
Assessment Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
- UMLS CUI [1,3]
- C2985720
Beschrijving
Assessment Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
- UMLS CUI [1,3]
- C0040223
Beschrijving
Vital Signs
Datatype
integer
Alias
- UMLS CUI [1]
- C0518766
Beschrijving
Location of blood pressure measurement
Datatype
integer
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Pulse Rate
Datatype
integer
Maateenheden
- Beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
12 Lead ECG 1
Alias
- UMLS CUI-1
- C0013798
Beschrijving
ECG Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0011008
Beschrijving
ECG time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Beschrijving
ECG Interpretation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Beschrijving
Height and Weight
Alias
- UMLS CUI-1
- C0005890
- UMLS CUI-3
- C0005910
Beschrijving
Assessment Date
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
BMI
Datatype
float
Maateenheden
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beschrijving
Previous Diabetes Medication Use
Alias
- UMLS CUI-1
- C0011849
Beschrijving
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Beschrijving
Potential childbearing
Datatype
boolean
Alias
- UMLS CUI [1]
- C3831118
Beschrijving
Reason Pregnancy Test Not Done
Datatype
integer
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
Urine Sample
Datatype
integer
Alias
- UMLS CUI [1]
- C0200354
Beschrijving
Pregnancy Test: Date
Datatype
date
Maateenheden
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschrijving
Pregnancy test
Datatype
text
Alias
- UMLS CUI [1]
- C0427777
Similar models
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])