ID

39999

Description

Comparison of Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan; ODM derived from: https://clinicaltrials.gov/show/NCT01409408

Link

https://clinicaltrials.gov/show/NCT01409408

Keywords

Versions (1)
  1. 3/9/20 3/9/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 9, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01409408

English

Eligibility Hypertension NCT01409408

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
those patients without anti-hypertensive drug prescribed in the last 4 weeks with office systolic blood pressure between 140 and 159 mmhg and diastolic between 90 and 109 mmhg.
Description

Antihypertensive Agents Absent | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
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 | Antidiabetics Oral Unchanged | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
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 of level 3 to 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 Diseases | 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 Ectopic beats

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
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Similar models

Eligibility Hypertension NCT01409408

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])
Antihypertensive Agents Absent | Systolic Pressure | Diastolic blood pressure
Item
those patients without anti-hypertensive drug prescribed in the last 4 weeks with office systolic blood pressure between 140 and 159 mmhg and diastolic between 90 and 109 mmhg.
boolean
C0003364 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral 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])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0442739 (UMLS CUI [2,3])
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 of level 3 to 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 Diseases | 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 Ectopic beats
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])
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