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ID
19778
Beschrijving
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.
Trefwoorden
Versies (2)
- 24-11-16 24-11-16 -
- 28-01-17 28-01-17 -
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28 januari 2017
DOI
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Creative Commons BY-NC 3.0
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Visit 1 Run-In Exclusion Criteria NCT01117584
Visit 1 Run-In Exclusion Criteria NCT01117584
- StudyEvent: ODM
Similar models
Visit 1 Run-In Exclusion Criteria NCT01117584
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
CL Item
Inclusion (1)
CL Item
Exclusion (2)
Eligibility
Item
Is the subject fully eligible per the Exclusion Criteria?
boolean
C0013893 (UMLS CUI [1])
Item
If No, please select Exclusion Criterion that makes the subject ineligible.
text
C0680251 (UMLS CUI [1])
Code List
If No, please select Exclusion Criterion that makes the subject ineligible.
CL Item
Subject has any known complication of T2DM indicating a late disease state that in the investigator´s opinion should preclude the subject from participation. (1)
CL Item
Subject has type 1 diabetes mellitus (2)
CL Item
Subject is in need of insulin therapy or has received insulin within 3 month prior to Visit 1, with the exception of acute use of < 7 days. (3)
CL Item
Subject has a serum creatinine higher than upper limit of normal range at Visit 1. (4)
CL Item
Subject has an ALT and/or AST higher than 3 times upper limit of normal range or has a total bilirubin more than 2 times upper limit of normal at Visit 1. (5)
CL Item
Subject has a urinary microalbumin/creatinine ratio above or equal to 300 mg/g at Visit 1. (6)
CL Item
Subject has a symptomatic UTIor symptomatic genital infection at Visit 1 or during the placebo run-in period, including just prior to randomization at Visit 2 (7)
CL Item
Subject has persistant, uncontrolled severe hypertension as indicated by a systolic blood pressure > 180 mmHg or a diastolic blood pressure of > 110 mmHg taken in a sitting position after 5 minutes of rest on at least 2 measurements (within 30 minutes of each other) at Visit 1. (8)
CL Item
Subject has a significant cardiovascular disease, such as myocaridal infarction or a vascular intervention (e.g angioplasty or stent) wihtin 3 month prior to Visit 1, or history of heart failure (Ney York Heart Association [NYHA]Class III-IV). (9)
CL Item
Subject is known to have hepatitis or be a carrier of hepatits B surface antigen (HBsAG), hepatitis C virus (HCV) antibody (enzyme linked immunosorbent assay [ELISA] plus confirmatory test), or is known positve for human immunodeficiency virus (HIV)HIV-1 and/or HIV-2. (10)
CL Item
Subject is currently receiving an excluded medication (loop-diuretics or systemic corticosteroids) or has received any other oral anti-diabetic drug except for metformin within 3 month prior to Visit 1. (11)
CL Item
Subject has history of lactic acidosis. (12)
CL Item
Subject has a history of drug or alcohol abuse/dependency within 12 month prior to Visit 1 as defined in the Diagnostic and Statistical Manual IV (DSM-IV). (13)
CL Item
Subject has had a malignancyin the last 5 years, except for adequately treated basal or squamous cell carcinoma in situ of the cervix. (14)
CL Item
Female subject who is pregnant, lactating or pre-menopausal with positive serum pregnancy test (hCG) at Visit 1 or has an intention of becoming pregnant. (15)
CL Item
Subject has an unstable medical or psychiatric illness. (16)
CL Item
Subject has known or suspected hypersensitivity to ASP1941 or any components of the formulations used. (17)
CL Item
Subject has previously received ASP1941 (18)
CL Item
Subject is concurrently participating in another drug study or has received an investigational drug within 30 days (or the limit set by natinal law, whichever is longer) prior to Visit 1. (19)
CL Item
Subject has any concurrent illness which, in the opinion of the investigator, may interfere with traetment or evaluation of safety or completion of this study. (20)
CL Item
In the Investigator´s judgment, the subject is unable to adhere to the treatment regimen, protocol procedures or study requirements. (21)