ID

19389

Description

Olmesartan Medoxomil and Diabetic Nephropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00362960

Link

https://clinicaltrials.gov/show/NCT00362960

Keywords

Versions (1)
  1. 12/28/16 12/28/16 -
Uploaded on

December 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00362960

English

Eligibility Type 2 Diabetes Mellitus NCT00362960

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female european out-patients
Description

Gender | Outpatients european

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0029921
UMLS CUI [2,2]
C0239307
greater than or equal to 30 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes first diagnosed at greater than or equal to 30 years of age
Description

Diabetes Mellitus, Non-Insulin-Dependent | Age

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0001779
urinary protein excretion between 200-4000 mg/day exclusive
Description

24 hour urine protein excretion test Exclusive

Data type

boolean

Alias
UMLS CUI [1,1]
C0202204
UMLS CUI [1,2]
C1548966
mean sitting dbp less than or equal to 110 mghg
Description

Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
medically justifiable to withdraw antihypertensive treatment due to poor tolerability or inefficacy of previous treatment, or verification that treatment is still necessary
Description

Antihypertensive therapy Withdrawal | Therapeutic procedure Tolerable Poor | Therapeutic procedure Lack of Efficacy | Verification Therapeutic procedure Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C2349954
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C4053931
UMLS CUI [2,3]
C0542537
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0235828
UMLS CUI [4,1]
C1711411
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0686904
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
females pregnant, nursing or planning to become pregnant or were of childbearing potential and not using acceptable methods of contraception
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332268
secondary forms of hypertension other than diabetic nephropathy, malignant hypertension or patients with sitting dbp exceeding 110 mmhg or sitting sbp exceeding 200 mmhg
Description

Secondary hypertension | Diabetic Nephropathy | Malignant Hypertension | Sitting diastolic blood pressure | Sitting systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0011881
UMLS CUI [3]
C0020540
UMLS CUI [4]
C1319894
UMLS CUI [5]
C1319893
ecg evidence of 2nd or 3rd degree av-block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia
Description

Second degree atrioventricular block Evidence Electrocardiography | Complete atrioventricular block Evidence Electrocardiography | Atrial Fibrillation | Cardiac Arrhythmia Treatment required for | Bradycardia

Data type

boolean

Alias
UMLS CUI [1,1]
C0264906
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C1623258
UMLS CUI [2,1]
C0151517
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C1623258
UMLS CUI [3]
C0004238
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0332121
UMLS CUI [5]
C0428977
presence of significant cardiovascular disease
Description

Cardiovascular Disease Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0750502
significant cerebrovascular disease, gastrointestinal, haematological or hepatic disease or myocardial infarction in last 12 months or a previous history of any serious underlying disease
Description

Cerebrovascular Disorder Significant | Gastrointestinal Disease Significant | Hematological Disease Significant | Liver disease Significant | Myocardial Infarction | Comorbidity Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0007820
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0750502
UMLS CUI [3,1]
C0018939
UMLS CUI [3,2]
C0750502
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0750502
UMLS CUI [5]
C0027051
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0205404
concurrent renal disease, nephrectomy and/or renal transplant, serum creatinine level greater than or equal to 2.0 mg/dl or creatinine clearance clcr less than or equal to 50 ml/min
Description

Kidney Disease | Nephrectomy | Kidney Transplantation | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0027695
UMLS CUI [3]
C0022671
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0373595
clinically significant lab abnormalities (asat/sgot, alat/sgpt and γ-gt )
Description

LABORATORY ABNORMALITIES Clinical Significance | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gamma-glutamyl transferase

Data type

boolean

Alias
UMLS CUI [1,1]
C1853129
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0017040
serum potassium level < 2.5 mmol/l or > 5.5 mmol/l
Description

Serum potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0302353
treatment of concurrent indications with drugs or medication which could have influenced bp
Description

Pharmaceutical Preparations Affecting Blood Pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005823
history of hypersensitivity, lack of response or contraindication to ang ii-antagonists, hctz or atenolol, or hypersensitivity to related drugs (cross-allergy)
Description

Hypersensitivity Angiotensin II receptor antagonist | Angiotensin II receptor antagonist Poor response to treatment | Medical contraindication Angiotensin II receptor antagonist | Hypersensitivity Hydrochlorothiazide | Hydrochlorothiazide Poor response to treatment | Medical contraindication Hydrochlorothiazide | Hypersensitivity Atenolol | Atenolol Poor response to treatment | Medical contraindication Atenolol | Hypersensitivity Pharmaceutical Preparations Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0521942
UMLS CUI [2,1]
C0521942
UMLS CUI [2,2]
C1320680
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0521942
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0020261
UMLS CUI [5,1]
C0020261
UMLS CUI [5,2]
C1320680
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0020261
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0004147
UMLS CUI [8,1]
C0004147
UMLS CUI [8,2]
C1320680
UMLS CUI [9,1]
C1301624
UMLS CUI [9,2]
C0004147
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0013227
UMLS CUI [10,3]
C0439849
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00362960

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Outpatients european
Item
male or female european out-patients
boolean
C0079399 (UMLS CUI [1])
C0029921 (UMLS CUI [2,1])
C0239307 (UMLS CUI [2,2])
Age
Item
greater than or equal to 30 years of age
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Age
Item
type 2 diabetes first diagnosed at greater than or equal to 30 years of age
boolean
C0011860 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
24 hour urine protein excretion test Exclusive
Item
urinary protein excretion between 200-4000 mg/day exclusive
boolean
C0202204 (UMLS CUI [1,1])
C1548966 (UMLS CUI [1,2])
Sitting diastolic blood pressure mean
Item
mean sitting dbp less than or equal to 110 mghg
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Antihypertensive therapy Withdrawal | Therapeutic procedure Tolerable Poor | Therapeutic procedure Lack of Efficacy | Verification Therapeutic procedure Patient need for
Item
medically justifiable to withdraw antihypertensive treatment due to poor tolerability or inefficacy of previous treatment, or verification that treatment is still necessary
boolean
C0585941 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C4053931 (UMLS CUI [2,2])
C0542537 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0235828 (UMLS CUI [3,2])
C1711411 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0686904 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Lacking
Item
females pregnant, nursing or planning to become pregnant or were of childbearing potential and not using acceptable methods of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
Secondary hypertension | Diabetic Nephropathy | Malignant Hypertension | Sitting diastolic blood pressure | Sitting systolic blood pressure
Item
secondary forms of hypertension other than diabetic nephropathy, malignant hypertension or patients with sitting dbp exceeding 110 mmhg or sitting sbp exceeding 200 mmhg
boolean
C0155616 (UMLS CUI [1])
C0011881 (UMLS CUI [2])
C0020540 (UMLS CUI [3])
C1319894 (UMLS CUI [4])
C1319893 (UMLS CUI [5])
Second degree atrioventricular block Evidence Electrocardiography | Complete atrioventricular block Evidence Electrocardiography | Atrial Fibrillation | Cardiac Arrhythmia Treatment required for | Bradycardia
Item
ecg evidence of 2nd or 3rd degree av-block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia
boolean
C0264906 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,3])
C0151517 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C1623258 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0332121 (UMLS CUI [4,2])
C0428977 (UMLS CUI [5])
Cardiovascular Disease Significant
Item
presence of significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Cerebrovascular Disorder Significant | Gastrointestinal Disease Significant | Hematological Disease Significant | Liver disease Significant | Myocardial Infarction | Comorbidity Serious
Item
significant cerebrovascular disease, gastrointestinal, haematological or hepatic disease or myocardial infarction in last 12 months or a previous history of any serious underlying disease
boolean
C0007820 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0018939 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5])
C0009488 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
Kidney Disease | Nephrectomy | Kidney Transplantation | Creatinine measurement, serum | Creatinine clearance measurement
Item
concurrent renal disease, nephrectomy and/or renal transplant, serum creatinine level greater than or equal to 2.0 mg/dl or creatinine clearance clcr less than or equal to 50 ml/min
boolean
C0022658 (UMLS CUI [1])
C0027695 (UMLS CUI [2])
C0022671 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
LABORATORY ABNORMALITIES Clinical Significance | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gamma-glutamyl transferase
Item
clinically significant lab abnormalities (asat/sgot, alat/sgpt and γ-gt )
boolean
C1853129 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0017040 (UMLS CUI [4])
Serum potassium measurement
Item
serum potassium level < 2.5 mmol/l or > 5.5 mmol/l
boolean
C0302353 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Blood Pressure
Item
treatment of concurrent indications with drugs or medication which could have influenced bp
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
Hypersensitivity Angiotensin II receptor antagonist | Angiotensin II receptor antagonist Poor response to treatment | Medical contraindication Angiotensin II receptor antagonist | Hypersensitivity Hydrochlorothiazide | Hydrochlorothiazide Poor response to treatment | Medical contraindication Hydrochlorothiazide | Hypersensitivity Atenolol | Atenolol Poor response to treatment | Medical contraindication Atenolol | Hypersensitivity Pharmaceutical Preparations Related
Item
history of hypersensitivity, lack of response or contraindication to ang ii-antagonists, hctz or atenolol, or hypersensitivity to related drugs (cross-allergy)
boolean
C0020517 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
C0521942 (UMLS CUI [2,1])
C1320680 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0521942 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0020261 (UMLS CUI [4,2])
C0020261 (UMLS CUI [5,1])
C1320680 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0020261 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0004147 (UMLS CUI [7,2])
C0004147 (UMLS CUI [8,1])
C1320680 (UMLS CUI [8,2])
C1301624 (UMLS CUI [9,1])
C0004147 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0013227 (UMLS CUI [10,2])
C0439849 (UMLS CUI [10,3])
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