ID

29879

Beschreibung

Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia; ODM derived from: https://clinicaltrials.gov/show/NCT00889226

Link

https://clinicaltrials.gov/show/NCT00889226

Stichworte

Versionen (2)
  1. 24.04.18 24.04.18 -
  2. 25.04.18 25.04.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. April 2018

DOI

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Creative Commons BY 4.0
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Eligibility Hypercholesterolemia With Type2DM NCT00889226

Englisch

Eligibility Hypercholesterolemia With Type2DM NCT00889226

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 25yrs~75yrs
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
fasting tg <400mg/dl, ldl-c ≥130mg/dl
Beschreibung

Serum fasting triglyceride measurement | Low density lipoprotein cholesterol measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0582824
UMLS CUI [2]
C0202117
3months > diagnosed type2 dm, with oad, hba1c ≤ 10.0% or first diagnosed type2 dm, 6.5%≤hba1c≤10.0%
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length | Antidiabetics Oral | Hemoglobin A1c measurement | Non-Insulin-Dependent Diabetes Mellitus Diagnosis Firstly

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0474680
UMLS CUI [4,1]
C0011860
UMLS CUI [4,2]
C0011900
UMLS CUI [4,3]
C1279901
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
type1 dm, gestational diabetes
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Gestational Diabetes

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0085207
patient need to treat with insulin
Beschreibung

Patient need for Insulin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0021641
patient with operational treatment for severe diabetic complication
Beschreibung

Operative Surgical Procedures Complications of Diabetes Mellitus Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0342257
UMLS CUI [1,3]
C0205082
uncontrolled hypothyroidism
Beschreibung

Hypothyroidism Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020676
UMLS CUI [1,2]
C0205318
unstable angina, mi, transient ischemic attack(tia), stroke, pci, heart failure within 3 months (nyha class4)
Beschreibung

Angina, Unstable | Myocardial Infarction | Transient Ischemic Attack | Cerebrovascular accident | Percutaneous Coronary Intervention | Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0038454
UMLS CUI [5]
C1532338
UMLS CUI [6,1]
C0018801
UMLS CUI [6,2]
C1275491
severe hypertension (sbp ≥ 180 or dbp ≥ 110mmhg)
Beschreibung

Hypertension, severe | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
renal disorder (serum creatinine ≥ 2.0mg/dl)
Beschreibung

Kidney Disease | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0201976
hepatic disorder (ast or alt ≥ 2.5 x unl)
Beschreibung

Liver diseases | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
creatinine kinase > 2.5 x unl
Beschreibung

Elevated creatinine kinase

Datentyp

boolean

Alias
UMLS CUI [1]
C1657311
gravida or lactation phase
Beschreibung

Gravidity | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0600457
UMLS CUI [2]
C0006147
administration of atorvastatin, rosuvastatin, pitavastatin
Beschreibung

atorvastatin | rosuvastatin | pitavastatin

Datentyp

boolean

Alias
UMLS CUI [1]
C0286651
UMLS CUI [2]
C0965129
UMLS CUI [3]
C1101838
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Ähnliche Modelle

Eligibility Hypercholesterolemia With Type2DM NCT00889226

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 25yrs~75yrs
boolean
C0001779 (UMLS CUI [1])
Serum fasting triglyceride measurement | Low density lipoprotein cholesterol measurement
Item
fasting tg <400mg/dl, ldl-c ≥130mg/dl
boolean
C0582824 (UMLS CUI [1])
C0202117 (UMLS CUI [2])
Non-Insulin-Dependent Diabetes Mellitus Disease length | Antidiabetics Oral | Hemoglobin A1c measurement | Non-Insulin-Dependent Diabetes Mellitus Diagnosis Firstly
Item
3months > diagnosed type2 dm, with oad, hba1c ≤ 10.0% or first diagnosed type2 dm, 6.5%≤hba1c≤10.0%
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0474680 (UMLS CUI [3])
C0011860 (UMLS CUI [4,1])
C0011900 (UMLS CUI [4,2])
C1279901 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Gestational Diabetes
Item
type1 dm, gestational diabetes
boolean
C0011854 (UMLS CUI [1])
C0085207 (UMLS CUI [2])
Patient need for Insulin
Item
patient need to treat with insulin
boolean
C0686904 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
Operative Surgical Procedures Complications of Diabetes Mellitus Severe
Item
patient with operational treatment for severe diabetic complication
boolean
C0543467 (UMLS CUI [1,1])
C0342257 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Hypothyroidism Uncontrolled
Item
uncontrolled hypothyroidism
boolean
C0020676 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Angina, Unstable | Myocardial Infarction | Transient Ischemic Attack | Cerebrovascular accident | Percutaneous Coronary Intervention | Heart failure New York Heart Association Classification
Item
unstable angina, mi, transient ischemic attack(tia), stroke, pci, heart failure within 3 months (nyha class4)
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C1532338 (UMLS CUI [5])
C0018801 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
Hypertension, severe | Systolic Pressure | Diastolic blood pressure
Item
severe hypertension (sbp ≥ 180 or dbp ≥ 110mmhg)
boolean
C4013784 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Kidney Disease | Creatinine measurement, serum
Item
renal disorder (serum creatinine ≥ 2.0mg/dl)
boolean
C0022658 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
Liver diseases | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
hepatic disorder (ast or alt ≥ 2.5 x unl)
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Elevated creatinine kinase
Item
creatinine kinase > 2.5 x unl
boolean
C1657311 (UMLS CUI [1])
Gravidity | Breast Feeding
Item
gravida or lactation phase
boolean
C0600457 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
atorvastatin | rosuvastatin | pitavastatin
Item
administration of atorvastatin, rosuvastatin, pitavastatin
boolean
C0286651 (UMLS CUI [1])
C0965129 (UMLS CUI [2])
C1101838 (UMLS CUI [3])
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