ID

17378

Description

Olmesartan Medoxomil in Hypertension and Renal Impairment; ODM derived from: https://clinicaltrials.gov/show/NCT00151827

Link

https://clinicaltrials.gov/show/NCT00151827

Keywords

  1. 9/10/16 9/10/16 -
Uploaded on

September 10, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Essential Hypertension NCT00151827

Eligibility Essential Hypertension NCT00151827

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
mean sitting bp prior to randomization of 140-180/90-109 mmhg;
Description

Sitting blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C0580946
UMLS CUI [1,2]
C0444504
renal impairment prior to randomization of mild (50 ≤ clcr ≥ 80 ml/min) to moderate (30 ≤ clcr ≥50 ml/min) severity
Description

Renal Insufficiency Mild | Renal Insufficiency Moderate | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C0373595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
malignant hypertension or sitting bp greater than 180/109 mmhg;
Description

Malignant Hypertension | Sitting blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0020540
UMLS CUI [2]
C0580946
severe heart failure, severe renal disease;
Description

Heart failure Severe | Kidney Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
recent history of myocardial infarction, stroke or transient ischemic attack;
Description

Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
history, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial;
Description

Gastrointestinal Disease Significant Evidence of | Respiration Disorder | Hematological Disease | Metabolic Disease | Immune System Disease | Disease Interferes with Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332120
UMLS CUI [2]
C0035204
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0025517
UMLS CUI [5]
C0021053
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2348568
hypersensitivity or contraindications to arbs or ace inhibitors or any cross allergy;
Description

Hypersensitivity Angiotensin II receptor antagonist | Medical contraindication Angiotensin II receptor antagonist | Hypersensitivity Angiotensin-Converting Enzyme Inhibitors | Medical contraindication Angiotensin-Converting Enzyme Inhibitors | Hypersensitivity Allergens Cross Reactive

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0521942
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0521942
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0003015
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0003015
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0002092
UMLS CUI [5,3]
C0010357
treatment with dis-allowed medication;
Description

Illicit Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0086190
pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Inadequate

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0205412
history of drug and/or alcohol abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586

Similar models

Eligibility Essential Hypertension NCT00151827

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Sitting blood pressure mean
Item
mean sitting bp prior to randomization of 140-180/90-109 mmhg;
boolean
C0580946 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Renal Insufficiency Mild | Renal Insufficiency Moderate | Creatinine clearance measurement
Item
renal impairment prior to randomization of mild (50 ≤ clcr ≥ 80 ml/min) to moderate (30 ≤ clcr ≥50 ml/min) severity
boolean
C1565489 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0373595 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Malignant Hypertension | Sitting blood pressure
Item
malignant hypertension or sitting bp greater than 180/109 mmhg;
boolean
C0020540 (UMLS CUI [1])
C0580946 (UMLS CUI [2])
Heart failure Severe | Kidney Disease Severe
Item
severe heart failure, severe renal disease;
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
recent history of myocardial infarction, stroke or transient ischemic attack;
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Gastrointestinal Disease Significant Evidence of | Respiration Disorder | Hematological Disease | Metabolic Disease | Immune System Disease | Disease Interferes with Study Subject Participation Status
Item
history, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial;
boolean
C0017178 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0035204 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
Hypersensitivity Angiotensin II receptor antagonist | Medical contraindication Angiotensin II receptor antagonist | Hypersensitivity Angiotensin-Converting Enzyme Inhibitors | Medical contraindication Angiotensin-Converting Enzyme Inhibitors | Hypersensitivity Allergens Cross Reactive
Item
hypersensitivity or contraindications to arbs or ace inhibitors or any cross allergy;
boolean
C0020517 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0521942 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0003015 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0003015 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0002092 (UMLS CUI [5,2])
C0010357 (UMLS CUI [5,3])
Illicit Drugs
Item
treatment with dis-allowed medication;
boolean
C0086190 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Inadequate
Item
pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
Substance Use Disorders
Item
history of drug and/or alcohol abuse
boolean
C0038586 (UMLS CUI [1])

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