ID

40083

Description

Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients Not Controlled by Amlodipine; ODM derived from: https://clinicaltrials.gov/show/NCT01603940

Link

https://clinicaltrials.gov/show/NCT01603940

Keywords

Versions (1)
  1. 3/11/20 3/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 11, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hypertension NCT01603940

English

Eligibility Hypertension NCT01603940

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ambulatorial patients with age between 40 and 70 years-old.
Description

Outpatients | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
systemic arterial hypertension previously diagnosed and in use of two or less anti-hypertensive drugs in the preceding 4 weeks.
Description

Hypertensive disease | Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
type 2 diabetes mellitus in use of oral medication that were not changed in the preceding 4 weeks. glycated hemoglobin a1c less than 9.0%.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Oral medication unchanged | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C0442739
UMLS CUI [3]
C0474680
accepted the consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
office systolic blood pressure equal or more than 180 mmhg, with or without treatment
Description

Systolic Pressure | Therapy | Therapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0087111
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332197
office diastolic blood pressure equal or more than 110 mmhg, with or without treatment
Description

Diastolic blood pressure | Therapy | Therapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C0087111
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332197
evidences of a secondary cause for hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
glycated hemoglobin a1c > 9.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
insulin therapy
Description

Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0557978
chronic kidney disease stage 4 or 5 or in dialysis
Description

Chronic Kidney Disease Stage | Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
UMLS CUI [2]
C0011946
advanced target organ lesion, obtained by history or additional exams, and defined by: previous myocardial infarction, heart failure with ejection fraction less than 40%, cerebral vascular accident (ischemic or hemorrhagic), peripheral vascular disease (claudication or doppler with obstruction > 50% of vascular lumen), retinopathy with visual loss, symptomatic neuropathy.
Description

Target Organ Lesion Advanced | Myocardial Infarction | Heart failure | Cardiac ejection fraction | Ischemic stroke | Brain hemorrhage | Peripheral Vascular Disease | Claudication | Vascular occlusion Percentage Doppler Ultrasound | Retinal Disease with Visual loss | Neuropathy Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0221198
UMLS CUI [1,4]
C0205179
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0232174
UMLS CUI [5]
C0948008
UMLS CUI [6]
C0553692
UMLS CUI [7]
C0085096
UMLS CUI [8]
C1456822
UMLS CUI [9,1]
C1096458
UMLS CUI [9,2]
C0439165
UMLS CUI [9,3]
C0162481
UMLS CUI [10,1]
C0035309
UMLS CUI [10,2]
C0332287
UMLS CUI [10,3]
C3665346
UMLS CUI [11,1]
C0442874
UMLS CUI [11,2]
C0231220
cardiac arrhythmias, except for ectopic beats
Description

Cardiac Arrhythmia | Exception Premature Cardiac Complex

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0340464
any clinical or disabling condition that, in the opinion of the investigators, may confound or prejudice study results.
Description

Medical condition Interferes with Research results | Disabling condition Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C4061999
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
severe mitral regurgitation.
Description

Mitral Valve Insufficiency Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0026266
UMLS CUI [1,2]
C0205082
women in fertile age without contraceptive methods in use.
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
breastfeeding women.
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
Back to the top of the page

Similar models

Eligibility Hypertension NCT01603940

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
ambulatorial patients with age between 40 and 70 years-old.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hypertensive disease | Antihypertensive Agents Quantity
Item
systemic arterial hypertension previously diagnosed and in use of two or less anti-hypertensive drugs in the preceding 4 weeks.
boolean
C0020538 (UMLS CUI [1])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Diabetes Mellitus, Non-Insulin-Dependent | Oral medication unchanged | Hemoglobin A1c measurement
Item
type 2 diabetes mellitus in use of oral medication that were not changed in the preceding 4 weeks. glycated hemoglobin a1c less than 9.0%.
boolean
C0011860 (UMLS CUI [1])
C0175795 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0474680 (UMLS CUI [3])
Informed Consent
Item
accepted the consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure | Therapy | Therapy Absent
Item
office systolic blood pressure equal or more than 180 mmhg, with or without treatment
boolean
C0871470 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Diastolic blood pressure | Therapy | Therapy Absent
Item
office diastolic blood pressure equal or more than 110 mmhg, with or without treatment
boolean
C0428883 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Secondary hypertension
Item
evidences of a secondary cause for hypertension
boolean
C0155616 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycated hemoglobin a1c > 9.0%
boolean
C0474680 (UMLS CUI [1])
Insulin regime
Item
insulin therapy
boolean
C0557978 (UMLS CUI [1])
Chronic Kidney Disease Stage | Dialysis
Item
chronic kidney disease stage 4 or 5 or in dialysis
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
C0011946 (UMLS CUI [2])
Target Organ Lesion Advanced | Myocardial Infarction | Heart failure | Cardiac ejection fraction | Ischemic stroke | Brain hemorrhage | Peripheral Vascular Disease | Claudication | Vascular occlusion Percentage Doppler Ultrasound | Retinal Disease with Visual loss | Neuropathy Symptomatic
Item
advanced target organ lesion, obtained by history or additional exams, and defined by: previous myocardial infarction, heart failure with ejection fraction less than 40%, cerebral vascular accident (ischemic or hemorrhagic), peripheral vascular disease (claudication or doppler with obstruction > 50% of vascular lumen), retinopathy with visual loss, symptomatic neuropathy.
boolean
C1521840 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C0205179 (UMLS CUI [1,4])
C0027051 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0232174 (UMLS CUI [4])
C0948008 (UMLS CUI [5])
C0553692 (UMLS CUI [6])
C0085096 (UMLS CUI [7])
C1456822 (UMLS CUI [8])
C1096458 (UMLS CUI [9,1])
C0439165 (UMLS CUI [9,2])
C0162481 (UMLS CUI [9,3])
C0035309 (UMLS CUI [10,1])
C0332287 (UMLS CUI [10,2])
C3665346 (UMLS CUI [10,3])
C0442874 (UMLS CUI [11,1])
C0231220 (UMLS CUI [11,2])
Cardiac Arrhythmia | Exception Premature Cardiac Complex
Item
cardiac arrhythmias, except for ectopic beats
boolean
C0003811 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0340464 (UMLS CUI [2,2])
Medical condition Interferes with Research results | Disabling condition Interferes with Research results
Item
any clinical or disabling condition that, in the opinion of the investigators, may confound or prejudice study results.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C4061999 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Mitral Valve Insufficiency Severe
Item
severe mitral regurgitation.
boolean
C0026266 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Absent
Item
women in fertile age without contraceptive methods in use.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Breast Feeding
Item
breastfeeding women.
boolean
C0006147 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial