ID

29993

Description

Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00940667

Link

https://clinicaltrials.gov/show/NCT00940667

Keywords

Versions (1)
  1. 5/3/18 5/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00940667

English

Eligibility Hypertension NCT00940667

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients over 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
essential hypertensive patients whose blood pressure is not controlled before the study (sit dbp ≥ 90 mmhg for drug-treated patient, sit dbp ≥ 95 mmhg for drug-naïve patient)
Description

Essential Hypertension | Blood Pressure Uncontrolled Before Clinical Trial | Sitting diastolic blood pressure Pharmacotherapy | Sitting diastolic blood pressure Pharmacotherapy naive

Data type

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2,1]
C0005823
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C0008976
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0013216
UMLS CUI [4,1]
C1319894
UMLS CUI [4,2]
C0013216
UMLS CUI [4,3]
C0919936
non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit dbp ≥ 90mmhg)
Description

Amlodipine Unresponsive to Treatment | Sitting diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0051696
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C1319894
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
mean sit sbp ≥ 200 mmhg or mean sit dbp ≥ 120 mmhg at screening
Description

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
mean sit sbp ≥ 180 mmhg or mean sit dbp ≥ 120 mmhg after 4 weeks of amlodipine 5 mg treatment
Description

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Amlodipine

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3]
C0051696
has a history of hypersensitivity to dihydropyridines or angiotensin ii receptor blockers
Description

Hypersensitivity Dihydropyridines | Allergy to angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0012315
UMLS CUI [2]
C2585204
secondary hypertensive patient or suspected to be
Description

Secondary hypertension | Secondary hypertension Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
uncontrolled diabetes mellitus patients
Description

Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1]
C0421258
severe heart disease or severe neurovascular disease
Description

Heart Disease Severe | Neurovascular Disorder Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3898144
UMLS CUI [2,2]
C0205082
known as severe or malignant retinopathy
Description

Retinal Disease Severe | Retinal Disease Malignant

Data type

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0035309
UMLS CUI [2,2]
C0205282
patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (alt or ast)
Description

Hematological Disease | Kidney Disease | Creatinine measurement, serum | Liver disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
history of malignancy tumor
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
history of autoimmune disease
Description

Autoimmune Disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
history of alcohol or drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
positive to pregnancy test, nursing mother, has an intention on pregnancy
Description

Pregnancy test positive | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
considered by investigator as not appropriate to participate in the clinical study with othe reason
Description

Other Reason Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
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Similar models

Eligibility Hypertension NCT00940667

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients over 18 years of age
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension | Blood Pressure Uncontrolled Before Clinical Trial | Sitting diastolic blood pressure Pharmacotherapy | Sitting diastolic blood pressure Pharmacotherapy naive
Item
essential hypertensive patients whose blood pressure is not controlled before the study (sit dbp ≥ 90 mmhg for drug-treated patient, sit dbp ≥ 95 mmhg for drug-naïve patient)
boolean
C0085580 (UMLS CUI [1])
C0005823 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C1319894 (UMLS CUI [3,1])
C0013216 (UMLS CUI [3,2])
C1319894 (UMLS CUI [4,1])
C0013216 (UMLS CUI [4,2])
C0919936 (UMLS CUI [4,3])
Amlodipine Unresponsive to Treatment | Sitting diastolic blood pressure
Item
non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit dbp ≥ 90mmhg)
boolean
C0051696 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
mean sit sbp ≥ 200 mmhg or mean sit dbp ≥ 120 mmhg at screening
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Amlodipine
Item
mean sit sbp ≥ 180 mmhg or mean sit dbp ≥ 120 mmhg after 4 weeks of amlodipine 5 mg treatment
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0051696 (UMLS CUI [3])
Hypersensitivity Dihydropyridines | Allergy to angiotensin II receptor antagonist
Item
has a history of hypersensitivity to dihydropyridines or angiotensin ii receptor blockers
boolean
C0020517 (UMLS CUI [1,1])
C0012315 (UMLS CUI [1,2])
C2585204 (UMLS CUI [2])
Secondary hypertension | Secondary hypertension Suspected
Item
secondary hypertensive patient or suspected to be
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Diabetic - poor control
Item
uncontrolled diabetes mellitus patients
boolean
C0421258 (UMLS CUI [1])
Heart Disease Severe | Neurovascular Disorder Severe
Item
severe heart disease or severe neurovascular disease
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3898144 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Retinal Disease Severe | Retinal Disease Malignant
Item
known as severe or malignant retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
Hematological Disease | Kidney Disease | Creatinine measurement, serum | Liver disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (alt or ast)
boolean
C0018939 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
Malignant Neoplasms
Item
history of malignancy tumor
boolean
C0006826 (UMLS CUI [1])
Autoimmune Disease
Item
history of autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Substance Use Disorders
Item
history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy test positive | Breast Feeding | Pregnancy, Planned
Item
positive to pregnancy test, nursing mother, has an intention on pregnancy
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Other Reason Study Subject Participation Status Inappropriate
Item
considered by investigator as not appropriate to participate in the clinical study with othe reason
boolean
C3840932 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
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