ID
28843
Beschreibung
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
Stichworte
Versionen (2)
- 08.02.18 08.02.18 -
- 08.02.18 08.02.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
8. Februar 2018
DOI
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Lizenz
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
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Blood Pressure - sitting, Systolic
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beschreibung
Blood Pressure - sitting, Diastolic
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beschreibung
Heart Rate
Datentyp
integer
Maßeinheiten
- beats/ min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Cardiovascular Medical History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0007222
Beschreibung
Myocardial infarction
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027051
Beschreibung
Ischaemic heart disease without cardiomyopathy
Datentyp
integer
Alias
- UMLS CUI [1]
- C1869045
Beschreibung
Ischaemic heart disease with cardiomyopathy
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1869045
- UMLS CUI [1,2]
- C0878544
Beschreibung
Stable angina
Datentyp
integer
Alias
- UMLS CUI [1]
- C0340288
Beschreibung
Unstable angina
Datentyp
integer
Alias
- UMLS CUI [1]
- C0002965
Beschreibung
Atherosclerosis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0004153
Beschreibung
Valvular heart disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018824
Beschreibung
Peripheral vascular disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0085096
Beschreibung
Cerebrovascular disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0007820
Beschreibung
Transient ischaemic attack
Datentyp
integer
Alias
- UMLS CUI [1]
- C0007787
Beschreibung
Stroke
Datentyp
integer
Alias
- UMLS CUI [1]
- C0038454
Beschreibung
Cardiac arrest
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018790
Beschreibung
Coronary artery disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C1956346
Beschreibung
Heart failure (CHF and acute)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018801
Beschreibung
Arrhythmia
Datentyp
integer
Alias
- UMLS CUI [1]
- C0003811
Beschreibung
Left ventricular dysfunction
Datentyp
integer
Alias
- UMLS CUI [1]
- C0242698
Beschreibung
Pulmonary oedema
Datentyp
integer
Alias
- UMLS CUI [1]
- C0034063
Beschreibung
Hypertension
Datentyp
integer
Alias
- UMLS CUI [1]
- C0020538
Beschreibung
Oedema
Datentyp
integer
Alias
- UMLS CUI [1]
- C0013604
Beschreibung
Left ventricular hypertrophy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0149721
Beschreibung
Cardiomegaly
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018800
Beschreibung
Cardiomyopathy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0878544
Beschreibung
Diastolic dysfunction
Datentyp
integer
Alias
- UMLS CUI [1]
- C0520863
Beschreibung
Coronary artery by-pass
Datentyp
integer
Alias
- UMLS CUI [1]
- C0010055
Beschreibung
Angioplasty
Datentyp
integer
Alias
- UMLS CUI [1]
- C0162577
Beschreibung
STENT insertion
Datentyp
integer
Alias
- UMLS CUI [1]
- C0398087
Beschreibung
Cardiac transplantation
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018823
Beschreibung
Amputation
Datentyp
integer
Alias
- UMLS CUI [1]
- C0002688
Beschreibung
Pacemaker insertion
Datentyp
integer
Alias
- UMLS CUI [1]
- C0189843
Beschreibung
Carotid endarterectomy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0014099
Beschreibung
Vascular bypass graft (other than coronary)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0863745
Beschreibung
Diabetes Medical History
Alias
- UMLS CUI-1
- C0011849
- UMLS CUI-2
- C0262926
Beschreibung
Diabetic retinopathy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0011884
Beschreibung
Autonomic neuropathy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0259749
Beschreibung
Peripheral neuropathy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0031117
Beschreibung
Dyslipidaemia
Datentyp
integer
Alias
- UMLS CUI [1]
- C0242339
Beschreibung
Diabetic foot ulcer
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0085119
- UMLS CUI [1,2]
- C0206172
Beschreibung
Proteinuria/ nephropathy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0033687
- UMLS CUI [2]
- C0011881
Beschreibung
Microalbuminuria
Datentyp
integer
Alias
- UMLS CUI [1]
- C0730345
Beschreibung
Chronic renal Insufficiency / chronic renal failure
Datentyp
integer
Alias
- UMLS CUI [1]
- C0022661
- UMLS CUI [2]
- C0403447
Beschreibung
Other Medical Conditions of Interest
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0009488
- UMLS CUI-3
- C0262926
Beschreibung
Anaemia
Datentyp
integer
Alias
- UMLS CUI [1]
- C0002871
Beschreibung
Select status for each condition entered.
Datentyp
text
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
Select status for each condition entered.
Datentyp
integer
Alias
- UMLS CUI [1]
- C3176928
Beschreibung
Central Laboratory
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0022885
Beschreibung
Pre-Study Diabetes Treatment
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C0011849
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C1516637
Beschreibung
I f 'No', check the boxes corresponding to any of the inclusion criteria the subject failed
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C1516637
Beschreibung
inclusion criteria the subject failed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C1516637
- UMLS CUI [1,3]
- C0231175
Beschreibung
exception(s) Inclusion Criteria
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1705847
- UMLS CUI [1,2]
- C1512693
- UMLS CUI [1,3]
- C1516637
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C1516637
Beschreibung
I f 'Yes', check all boxes corresponding to the exclusion criteria that disqualified the subject from entry.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1516637
Beschreibung
exclusion criteria failed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1516637
Beschreibung
exception(s) Exclusion Criteria
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1705847
- UMLS CUI [1,2]
- C0680251
Beschreibung
Concomitant Medications Prompt
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0013227
Beschreibung
Subject Continuation
Alias
- UMLS CUI-1
- C0805733
- UMLS CUI-2
- C2348568
Ähnliche Modelle
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])