ID

30047

Beschrijving

A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1); ODM derived from: https://clinicaltrials.gov/show/NCT01390415

Link

https://clinicaltrials.gov/show/NCT01390415

Trefwoorden

  1. 05-05-18 05-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 mei 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Hypertension NCT01390415

Eligibility Hypertension NCT01390415

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diabetes mellitus
Beschrijving

Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
hypertension and has received losartan 50 mg or losartan 100 mg for at least 6 months
Beschrijving

Hypertensive disease | Losartan Dosage

Datatype

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0126174
UMLS CUI [2,2]
C0178602
microalbuminuria (defined as microalbuminuria > 30 mg/g and < 300 mg/g by spot urine test)
Beschrijving

Microalbuminuria Spot urine procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0730345
UMLS CUI [1,2]
C1272574
serum creatinine ≤1.5 mg/dl for men and ≤1.4mg/dl for women
Beschrijving

Creatinine measurement, serum | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
urinalysis with white blood cells (wbc) <5 cells per high power field
Beschrijving

Urinalysis Leukocytes cells/HPF Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0023516
UMLS CUI [1,3]
C0439358
UMLS CUI [1,4]
C1265611
results of hemoglobin a1c (hba1c), fasting blood glucose, serum creatinine, urine albumin/urine creatinine ratio and urinary analysis tests at baseline and 6 months after initiating the losartan therapy are available
Beschrijving

Hemoglobin A1c measurement | Fasting blood glucose measurement | Creatinine measurement, serum | Urine albumin/creatinine ratio measurement | Urinalysis | Status post Initiation Losartan

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2]
C0428568
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0455271
UMLS CUI [5]
C0042014
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C1704686
UMLS CUI [6,3]
C0126174
medical history and co-morbidities (if available) listed in medical records
Beschrijving

Medical History | Comorbidity | Medical Records

Datatype

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0009488
UMLS CUI [3]
C0025102
prescription information of antihypertensive regimen of losartan 50 mg or 100 mg available
Beschrijving

Prescription document | Antihypertensive therapy | Losartan Dosage

Datatype

boolean

Alias
UMLS CUI [1]
C1521941
UMLS CUI [2]
C0585941
UMLS CUI [3,1]
C0126174
UMLS CUI [3,2]
C0178602
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
treated with angiotensin-converting enzyme (ace) inhibitors or angiotensin-receptor blockers (arb) before initiated treatment with losartan 50 mg or losartan 100 mg
Beschrijving

Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Datatype

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
enrollment in another clinical trial
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Hypertension NCT01390415

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Hypertensive disease | Losartan Dosage
Item
hypertension and has received losartan 50 mg or losartan 100 mg for at least 6 months
boolean
C0020538 (UMLS CUI [1])
C0126174 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Microalbuminuria Spot urine procedure
Item
microalbuminuria (defined as microalbuminuria > 30 mg/g and < 300 mg/g by spot urine test)
boolean
C0730345 (UMLS CUI [1,1])
C1272574 (UMLS CUI [1,2])
Creatinine measurement, serum | Gender
Item
serum creatinine ≤1.5 mg/dl for men and ≤1.4mg/dl for women
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Urinalysis Leukocytes cells/HPF Quantity
Item
urinalysis with white blood cells (wbc) <5 cells per high power field
boolean
C0042014 (UMLS CUI [1,1])
C0023516 (UMLS CUI [1,2])
C0439358 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Hemoglobin A1c measurement | Fasting blood glucose measurement | Creatinine measurement, serum | Urine albumin/creatinine ratio measurement | Urinalysis | Status post Initiation Losartan
Item
results of hemoglobin a1c (hba1c), fasting blood glucose, serum creatinine, urine albumin/urine creatinine ratio and urinary analysis tests at baseline and 6 months after initiating the losartan therapy are available
boolean
C0474680 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0455271 (UMLS CUI [4])
C0042014 (UMLS CUI [5])
C0231290 (UMLS CUI [6,1])
C1704686 (UMLS CUI [6,2])
C0126174 (UMLS CUI [6,3])
Medical History | Comorbidity | Medical Records
Item
medical history and co-morbidities (if available) listed in medical records
boolean
C0262926 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0025102 (UMLS CUI [3])
Prescription document | Antihypertensive therapy | Losartan Dosage
Item
prescription information of antihypertensive regimen of losartan 50 mg or 100 mg available
boolean
C1521941 (UMLS CUI [1])
C0585941 (UMLS CUI [2])
C0126174 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
treated with angiotensin-converting enzyme (ace) inhibitors or angiotensin-receptor blockers (arb) before initiated treatment with losartan 50 mg or losartan 100 mg
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
Study Subject Participation Status
Item
enrollment in another clinical trial
boolean
C2348568 (UMLS CUI [1])

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