ID

30000

Description

Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00942344

Link

https://clinicaltrials.gov/show/NCT00942344

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 NCT00942344

English

Eligibility Hypertension NCT00942344

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged between 18 and 75
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with essential hypertension {95 mmhg ≤ sitdbp< 115 mmhg at the end of placebo run-in treatment period}
Description

Essential Hypertension | Sitting diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2]
C1319894
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with mean sitsbp ≥ 200 mmhg
Description

Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
patients with known hypersensitivity to dihydropyridine 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
patients with secondary hypertension or suspected secondary hypertension
Description

Secondary hypertension | Secondary hypertension Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
patients with malignant hypertension
Description

Malignant Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020540
patients who have received any medications with possible interactions with study drugs
Description

Pharmaceutical Preparations Interactions Possible Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C0332149
UMLS CUI [1,4]
C0013230
patients with uncontrolled diabetes
Description

Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1]
C0421258
patients with severe heart disease or severe cerebrovascular disease
Description

Heart Disease Severe | Cerebrovascular Disorder Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0007820
UMLS CUI [2,2]
C0205082
patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (alt or ast)
Description

Test Result Hematologic Clinical Significance | Kidney Disease | Creatinine measurement, serum | Liver disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C2826293
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
patients with a history of malignant disease
Description

Malignant disease

Data type

boolean

Alias
UMLS CUI [1]
C0442867
patients with a history of autoimmune disease
Description

Autoimmune Disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
Description

Pregnancy test positive | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
patients inappropriate to be included in study population due to other reasons at the discretion of the investigator
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 NCT00942344

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients aged between 18 and 75
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension | Sitting diastolic blood pressure
Item
patients with essential hypertension {95 mmhg ≤ sitdbp< 115 mmhg at the end of placebo run-in treatment period}
boolean
C0085580 (UMLS CUI [1])
C1319894 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Sitting systolic blood pressure mean
Item
patients with mean sitsbp ≥ 200 mmhg
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Hypersensitivity Dihydropyridines | Allergy to angiotensin II receptor antagonist
Item
patients with known hypersensitivity to dihydropyridine 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
patients with secondary hypertension or suspected secondary hypertension
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Malignant Hypertension
Item
patients with malignant hypertension
boolean
C0020540 (UMLS CUI [1])
Pharmaceutical Preparations Interactions Possible Investigational New Drugs
Item
patients who have received any medications with possible interactions with study drugs
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Diabetic - poor control
Item
patients with uncontrolled diabetes
boolean
C0421258 (UMLS CUI [1])
Heart Disease Severe | Cerebrovascular Disorder Severe
Item
patients with severe heart disease or severe cerebrovascular disease
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0007820 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Test Result Hematologic Clinical Significance | Kidney Disease | Creatinine measurement, serum | Liver disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (alt or ast)
boolean
C0456984 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
Malignant disease
Item
patients with a history of malignant disease
boolean
C0442867 (UMLS CUI [1])
Autoimmune Disease
Item
patients with a history of autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Pregnancy test positive | Breast Feeding | Pregnancy, Planned
Item
women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Other Reason Study Subject Participation Status Inappropriate
Item
patients inappropriate to be included in study population due to other reasons at the discretion of the investigator
boolean
C3840932 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
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