ID
44874
Description
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
Mots-clés
Versions (3)
- 10/08/2016 10/08/2016 -
- 28/09/2016 28/09/2016 -
- 18/02/2022 18/02/2022 - Martin Dugas
Détendeur de droits
Astellas Pharma Inc
Téléchargé le
18 février 2022
DOI
Pour une demande vous connecter.
Licence
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
Description
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Eligibility, Inclusion Criteria
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C0013893
Description
Informed Consent
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Age | Gender
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C0079399
Description
Type 2 Diabetes Mellitus
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011860
Description
HbA1c
Type de données
boolean
Alias
- UMLS CUI [1]
- C0019018
Description
Diabetes mellitus Medication
Type de données
boolean
Alias
- UMLS CUI [1]
- C0948092
Description
Diet | Exercise
Type de données
boolean
Alias
- UMLS CUI [1]
- C0012155
- UMLS CUI [2]
- C0015259
Description
BMI
Type de données
boolean
Alias
- UMLS CUI [1]
- C1305855
Description
Pregnancy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0032961
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Eligibility, Exclusion
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C0013893
Description
Complication
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009566
Description
Type 1 Diabetes mellitus
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011854
Description
insulin
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021641
Description
creatinine
Type de données
boolean
Alias
- UMLS CUI [1]
- C0201976
Description
ALT | AST | Bilirubin
Type de données
boolean
Alias
- UMLS CUI [1]
- C0201836
- UMLS CUI [2]
- C0201899
- UMLS CUI [3]
- C1278039
Description
microalbumin, creatinine
Type de données
boolean
Alias
- UMLS CUI [1]
- C2362049
- UMLS CUI [2]
- C0201976
Description
urinary tract infection | genital infection
Type de données
boolean
Alias
- UMLS CUI [1]
- C0042029
- UMLS CUI [2]
- C0729552
Description
hypertension
Type de données
text
Alias
- UMLS CUI [1]
- C0020538
Description
cardiovascular disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C0007222
Description
Hepatitis | HIV
Type de données
boolean
Alias
- UMLS CUI [1]
- C0019158
- UMLS CUI [2]
- C0019682
Description
medication
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013227
Description
lactic acidosis
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001125
Description
drug abuse | alcohol abuse
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013146
- UMLS CUI [2]
- C0085762
Description
malignancy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0006826
Description
lactating
Type de données
boolean
Alias
- UMLS CUI [1]
- C2828358
Description
mental ilness
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004936
Description
hypersensitivity
Type de données
boolean
Alias
- UMLS CUI [1]
- C0020517
Description
ASP1941
Type de données
boolean
Description
Drug study
Type de données
boolean
Description
illness
Type de données
boolean
Alias
- UMLS CUI [1]
- C0221423
Description
Eligibility
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013893
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Sex
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
Date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Age
Type de données
integer
Unités de mesure
- years
Alias
- UMLS CUI [1]
- C0001779
Description
Race
Type de données
integer
Alias
- UMLS CUI [1]
- C0034510
Description
Race, Other
Type de données
text
Alias
- UMLS CUI [1]
- C0034510
Description
Ethnicity
Type de données
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Primary Diagnosis
Alias
- UMLS CUI-1
- C0332137
Description
Subject Characteristics
Alias
- UMLS CUI-1
- C1706465
Description
Sexually active
Type de données
boolean
Alias
- UMLS CUI [1]
- C0241028
Description
Circumcision
Type de données
boolean
Alias
- UMLS CUI [1]
- C0008819
Description
Vascular Disease
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C1881056
Description
Date of Visit
Alias
- UMLS CUI-1
- C1320303
Description
Tobacco History
Alias
- UMLS CUI-1
- C1519384
Description
Tobacco History
Type de données
integer
Alias
- UMLS CUI [1]
- C1519384
Description
Tobacco type
Type de données
integer
Alias
- UMLS CUI [1]
- C3166496
Description
Tobacco quantity
Type de données
text
Alias
- UMLS CUI [1,1]
- C0040329
- UMLS CUI [1,2]
- C1265611
Description
Alcohol History
Alias
- UMLS CUI-1
- C0085762
Description
Alcohol History
Type de données
integer
Alias
- UMLS CUI [1]
- C0085762
Description
Alcohol quantity
Type de données
text
Alias
- UMLS CUI [1,1]
- C0001962
- UMLS CUI [1,2]
- C1265611
Description
Urinary Tract Infection History
Alias
- UMLS CUI-1
- C0042029
Description
Diagnosis | Urinary Tract Infection
Type de données
integer
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0042029
Description
History of Urinary Tract Infection
Type de données
boolean
Alias
- UMLS CUI [1]
- C0019664
- UMLS CUI [2]
- C0042029
Description
Urinary Tract Infection Occurrence
Type de données
text
Alias
- UMLS CUI [1]
- C0042029
- UMLS CUI [2]
- C2745955
Description
Site of Infection
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0475264
Description
Organism
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0029235
Description
Organism Lab
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0029235
Description
Onset Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0574845
Description
Ongoing
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0549178
Description
Recovery
Type de données
date
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C2004454
Description
Symptomatic
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0231220
Description
Treatment
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042029
- UMLS CUI [1,2]
- C0087111
Description
Genital Infection History
Alias
- UMLS CUI-1
- C0729552
Description
Diagnosis
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0729552
Description
History
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C2745955
Description
Occurence
Type de données
text
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C2745955
Description
Site of Infection
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0475264
- UMLS CUI [1,2]
- C0729552
Description
Organism
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0029235
Description
Confirmation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0029235
Description
Onset Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0574845
Description
Medical Condition Ongoing
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0549178
Description
Recovery
Type de données
date
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C2004454
Description
Symptomatic
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0231220
Description
Treatment
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0729552
- UMLS CUI [1,2]
- C0087111
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Physical Examination
Type de données
boolean
Alias
- UMLS CUI [1]
- C0031809
Description
Assessment Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C2985720
Description
Orthostatic vital signs
Alias
- UMLS CUI-1
- C0518766
Description
Assessment
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
Description
Assessment Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
- UMLS CUI [1,3]
- C2985720
Description
Assessment Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
- UMLS CUI [1,3]
- C0040223
Description
Vital Signs
Type de données
integer
Alias
- UMLS CUI [1]
- C0518766
Description
Location of blood pressure measurement
Type de données
integer
Alias
- UMLS CUI [1]
- C0005823
Description
Systolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Pulse Rate
Type de données
integer
Unités de mesure
- Beats/min
Alias
- UMLS CUI [1]
- C0232117
Description
12 Lead ECG 1
Alias
- UMLS CUI-1
- C0013798
Description
ECG Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0011008
Description
ECG time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Description
ECG Interpretation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Description
Height and Weight
Alias
- UMLS CUI-1
- C0005890
- UMLS CUI-3
- C0005910
Description
Assessment Date
Type de données
date
Alias
- UMLS CUI [1]
- C2985720
Description
Height
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
BMI
Type de données
float
Unités de mesure
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Description
Previous Diabetes Medication Use
Alias
- UMLS CUI-1
- C0011849
Description
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Description
Potential childbearing
Type de données
boolean
Alias
- UMLS CUI [1]
- C3831118
Description
Reason Pregnancy Test Not Done
Type de données
integer
Alias
- UMLS CUI [1]
- C0032976
Description
Urine Sample
Type de données
integer
Alias
- UMLS CUI [1]
- C0200354
Description
Pregnancy Test: Date
Type de données
date
Unités de mesure
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Description
Pregnancy test
Type de données
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])