ID
28843
Beschrijving
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Run-In - Visit 3
Trefwoorden
Versies (2)
- 08-02-18 08-02-18 -
- 08-02-18 08-02-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 februari 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723
Screening - Visit 2
- StudyEvent: ODM
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Blood Pressure - sitting, Systolic
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beschrijving
Blood Pressure - sitting, Diastolic
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/ min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Cardiovascular Medical History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0007222
Beschrijving
Myocardial infarction
Datatype
integer
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Ischaemic heart disease without cardiomyopathy
Datatype
integer
Alias
- UMLS CUI [1]
- C1869045
Beschrijving
Ischaemic heart disease with cardiomyopathy
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1869045
- UMLS CUI [1,2]
- C0878544
Beschrijving
Stable angina
Datatype
integer
Alias
- UMLS CUI [1]
- C0340288
Beschrijving
Unstable angina
Datatype
integer
Alias
- UMLS CUI [1]
- C0002965
Beschrijving
Atherosclerosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0004153
Beschrijving
Valvular heart disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0018824
Beschrijving
Peripheral vascular disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0085096
Beschrijving
Cerebrovascular disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0007820
Beschrijving
Transient ischaemic attack
Datatype
integer
Alias
- UMLS CUI [1]
- C0007787
Beschrijving
Stroke
Datatype
integer
Alias
- UMLS CUI [1]
- C0038454
Beschrijving
Cardiac arrest
Datatype
integer
Alias
- UMLS CUI [1]
- C0018790
Beschrijving
Coronary artery disease
Datatype
integer
Alias
- UMLS CUI [1]
- C1956346
Beschrijving
Heart failure (CHF and acute)
Datatype
integer
Alias
- UMLS CUI [1]
- C0018801
Beschrijving
Arrhythmia
Datatype
integer
Alias
- UMLS CUI [1]
- C0003811
Beschrijving
Left ventricular dysfunction
Datatype
integer
Alias
- UMLS CUI [1]
- C0242698
Beschrijving
Pulmonary oedema
Datatype
integer
Alias
- UMLS CUI [1]
- C0034063
Beschrijving
Hypertension
Datatype
integer
Alias
- UMLS CUI [1]
- C0020538
Beschrijving
Oedema
Datatype
integer
Alias
- UMLS CUI [1]
- C0013604
Beschrijving
Left ventricular hypertrophy
Datatype
integer
Alias
- UMLS CUI [1]
- C0149721
Beschrijving
Cardiomegaly
Datatype
integer
Alias
- UMLS CUI [1]
- C0018800
Beschrijving
Cardiomyopathy
Datatype
integer
Alias
- UMLS CUI [1]
- C0878544
Beschrijving
Diastolic dysfunction
Datatype
integer
Alias
- UMLS CUI [1]
- C0520863
Beschrijving
Coronary artery by-pass
Datatype
integer
Alias
- UMLS CUI [1]
- C0010055
Beschrijving
Angioplasty
Datatype
integer
Alias
- UMLS CUI [1]
- C0162577
Beschrijving
STENT insertion
Datatype
integer
Alias
- UMLS CUI [1]
- C0398087
Beschrijving
Cardiac transplantation
Datatype
integer
Alias
- UMLS CUI [1]
- C0018823
Beschrijving
Amputation
Datatype
integer
Alias
- UMLS CUI [1]
- C0002688
Beschrijving
Pacemaker insertion
Datatype
integer
Alias
- UMLS CUI [1]
- C0189843
Beschrijving
Carotid endarterectomy
Datatype
integer
Alias
- UMLS CUI [1]
- C0014099
Beschrijving
Vascular bypass graft (other than coronary)
Datatype
integer
Alias
- UMLS CUI [1]
- C0863745
Beschrijving
Diabetes Medical History
Alias
- UMLS CUI-1
- C0011849
- UMLS CUI-2
- C0262926
Beschrijving
Diabetic retinopathy
Datatype
integer
Alias
- UMLS CUI [1]
- C0011884
Beschrijving
Autonomic neuropathy
Datatype
integer
Alias
- UMLS CUI [1]
- C0259749
Beschrijving
Peripheral neuropathy
Datatype
integer
Alias
- UMLS CUI [1]
- C0031117
Beschrijving
Dyslipidaemia
Datatype
integer
Alias
- UMLS CUI [1]
- C0242339
Beschrijving
Diabetic foot ulcer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0085119
- UMLS CUI [1,2]
- C0206172
Beschrijving
Proteinuria/ nephropathy
Datatype
integer
Alias
- UMLS CUI [1]
- C0033687
- UMLS CUI [2]
- C0011881
Beschrijving
Microalbuminuria
Datatype
integer
Alias
- UMLS CUI [1]
- C0730345
Beschrijving
Chronic renal Insufficiency / chronic renal failure
Datatype
integer
Alias
- UMLS CUI [1]
- C0022661
- UMLS CUI [2]
- C0403447
Beschrijving
Other Medical Conditions of Interest
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0009488
- UMLS CUI-3
- C0262926
Beschrijving
Anaemia
Datatype
integer
Alias
- UMLS CUI [1]
- C0002871
Beschrijving
Select status for each condition entered.
Datatype
text
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Select status for each condition entered.
Datatype
integer
Alias
- UMLS CUI [1]
- C3176928
Beschrijving
Central Laboratory
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0022885
Beschrijving
Pre-Study Diabetes Treatment
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C0011849
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C1516637
Beschrijving
I f 'No', check the boxes corresponding to any of the inclusion criteria the subject failed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C1516637
Beschrijving
inclusion criteria the subject failed
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C1516637
- UMLS CUI [1,3]
- C0231175
Beschrijving
exception(s) Inclusion Criteria
Datatype
text
Alias
- UMLS CUI [1,1]
- C1705847
- UMLS CUI [1,2]
- C1512693
- UMLS CUI [1,3]
- C1516637
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C1516637
Beschrijving
I f 'Yes', check all boxes corresponding to the exclusion criteria that disqualified the subject from entry.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1516637
Beschrijving
exclusion criteria failed
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1516637
Beschrijving
exception(s) Exclusion Criteria
Datatype
text
Alias
- UMLS CUI [1,1]
- C1705847
- UMLS CUI [1,2]
- C0680251
Beschrijving
Concomitant Medications Prompt
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0013227
Beschrijving
Subject Continuation
Alias
- UMLS CUI-1
- C0805733
- UMLS CUI-2
- C2348568
Similar models
Screening - Visit 2
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0007222 (UMLS CUI-2)
C0878544 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0206172 (UMLS CUI [1,2])
C0011881 (UMLS CUI [2])
C0403447 (UMLS CUI [2])
C0009488 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0200354 (UMLS CUI [2])
C0013227 (UMLS CUI-2)
C0011849 (UMLS CUI-3)
C0011849 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,3])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C2169461 (UMLS CUI [1,2])