Informações:
Falhas:
ID
28773
Descrição
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180; ODM derived from: https://clinicaltrials.gov/show/NCT00907998
Link
https://clinicaltrials.gov/show/NCT00907998
Palavras-chave
Versões (1)
- 03/02/2018 03/02/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
3 de fevereiro de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT00907998
Eligibility Coronary Heart Disease NCT00907998
- StudyEvent: Eligibility
Similar models
Eligibility Coronary Heart Disease NCT00907998
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Gender | Coronary heart disease | Coronary heart disease Equivalent
Item
male and female chd or chd equivalent patients
boolean
C0079399 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C0010068 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0010068 (UMLS CUI [2])
C0010068 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
Body mass index
Item
body mass index (bmi) must be within the range of 20 to 35 kg/m2,
boolean
C1305855 (UMLS CUI [1])
Statin Stable | Exception Intolerance to Statin
Item
patient must have been on a stable statin therapy for >8 weeks prior to first dose except for the statin intolerant patients.
boolean
C0360714 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1744706 (UMLS CUI [2,2])
C0360714 (UMLS CUI [2,3])
C0205360 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1744706 (UMLS CUI [2,2])
C0360714 (UMLS CUI [2,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Illness Significant
Item
significant illness within two weeks prior to dosing.
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,2])
Triglycerides measurement
Item
triglycerides ≥ 500 mg/dl (5.65 mmol/l)
boolean
C0202236 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Condition compromises Evaluation Efficacy | Condition compromises Evaluation Safety
Item
any condition that in the opinion of the investigator or the novartis medical monitor would jeopardize the evaluation of efficacy or safety.
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C1280519 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0036043 (UMLS CUI [2,4])
C2945640 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C1280519 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0036043 (UMLS CUI [2,4])
Chronic heart failure New York Heart Association Classification
Item
presence of nyha class iii or iv chronic heart failure
boolean
C0264716 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction | Angioplasty | Stenting | Acute Coronary Syndrome | Angina, Unstable | Arterial embolism | Eligibility Criteria Study Protocol
Item
mi or angioplasty (including stenting), acute coronary syndrome (acs), unstable angina or arterial embolic disease within 6 months prior to do other protocol-defined inclusion/exclusion criteria may apply
boolean
C0027051 (UMLS CUI [1])
C0162577 (UMLS CUI [2])
C2348535 (UMLS CUI [3])
C0948089 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0549124 (UMLS CUI [6])
C1516637 (UMLS CUI [7,1])
C2348563 (UMLS CUI [7,2])
C0162577 (UMLS CUI [2])
C2348535 (UMLS CUI [3])
C0948089 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0549124 (UMLS CUI [6])
C1516637 (UMLS CUI [7,1])
C2348563 (UMLS CUI [7,2])