ID

30009

Description

To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone; ODM derived from: https://clinicaltrials.gov/show/NCT01070043

Link

https://clinicaltrials.gov/show/NCT01070043

Keywords

Versions (1)
  1. 5/4/18 5/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01070043

English

Eligibility Hypertension NCT01070043

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants over 18 years of age with hypertension defined as sitting systolic blood pressure between 140 mmhg and 180 mmhg or sitting diastolic blood pressure between 90 mmhg and 120 mmhg.
Description

Age | Hypertensive disease | Sitting systolic blood pressure | Sitting diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0020538
UMLS CUI [3]
C1319893
UMLS CUI [4]
C1319894
high risk participants ( defined as having: (diabetes mellitus, chronic renal disease, framingham 10-year risk score >10%, established coronary artery disease (cad), or cad equivalents including carotid artery disease, peripheral arterial disease (pad), abdominal aortic aneurysm (aaa))with hypertension defined as sitting systolic blood pressure between 130 mmhg and 180 mmhg or sitting diastolic blood pressure between 80 mmhg and 120 mmhg.
Description

Study Subject High risk | Diabetes Mellitus | Chronic Kidney Diseases | Framingham coronary heart disease 10 year risk score | Coronary Artery Disease Established | Coronary Artery Disease Equivalent | Carotid Artery Diseases | Peripheral Arterial Diseases | Aortic Aneurysm, Abdominal | Hypertensive disease | Sitting systolic blood pressure | Sitting diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0332167
UMLS CUI [2]
C0011849
UMLS CUI [3]
C1561643
UMLS CUI [4]
C1277687
UMLS CUI [5,1]
C1956346
UMLS CUI [5,2]
C0443211
UMLS CUI [6,1]
C1956346
UMLS CUI [6,2]
C0205163
UMLS CUI [7]
C0007273
UMLS CUI [8]
C1704436
UMLS CUI [9]
C0162871
UMLS CUI [10]
C0020538
UMLS CUI [11]
C1319893
UMLS CUI [12]
C1319894
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known 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
known new york heart association (nyha) functional class iv heart failure
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
history of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 3 months
Description

Myocardial Infarction | Transient Ischemic Attack | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0038454
clinically significant valvular disease
Description

Valvular disease

Data type

boolean

Alias
UMLS CUI [1]
C3258293
women who are pregnant, intend to become pregnant or are breastfeeding
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
participants who have severe medical condition(s) that in the view of the investigator prohibits participation in the study
Description

Medical condition Severe | Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332196
participants who have hypersensitivity to the investigational/ reference drug or any of the components in the formulation.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1705248
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hypertension NCT01070043

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Hypertensive disease | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
participants over 18 years of age with hypertension defined as sitting systolic blood pressure between 140 mmhg and 180 mmhg or sitting diastolic blood pressure between 90 mmhg and 120 mmhg.
boolean
C0001779 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C1319893 (UMLS CUI [3])
C1319894 (UMLS CUI [4])
Study Subject High risk | Diabetes Mellitus | Chronic Kidney Diseases | Framingham coronary heart disease 10 year risk score | Coronary Artery Disease Established | Coronary Artery Disease Equivalent | Carotid Artery Diseases | Peripheral Arterial Diseases | Aortic Aneurysm, Abdominal | Hypertensive disease | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
high risk participants ( defined as having: (diabetes mellitus, chronic renal disease, framingham 10-year risk score >10%, established coronary artery disease (cad), or cad equivalents including carotid artery disease, peripheral arterial disease (pad), abdominal aortic aneurysm (aaa))with hypertension defined as sitting systolic blood pressure between 130 mmhg and 180 mmhg or sitting diastolic blood pressure between 80 mmhg and 120 mmhg.
boolean
C0681850 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C1561643 (UMLS CUI [3])
C1277687 (UMLS CUI [4])
C1956346 (UMLS CUI [5,1])
C0443211 (UMLS CUI [5,2])
C1956346 (UMLS CUI [6,1])
C0205163 (UMLS CUI [6,2])
C0007273 (UMLS CUI [7])
C1704436 (UMLS CUI [8])
C0162871 (UMLS CUI [9])
C0020538 (UMLS CUI [10])
C1319893 (UMLS CUI [11])
C1319894 (UMLS CUI [12])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Secondary hypertension Suspected
Item
known or suspected secondary hypertension
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Heart failure New York Heart Association Classification
Item
known new york heart association (nyha) functional class iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction | Transient Ischemic Attack | Cerebrovascular accident
Item
history of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 3 months
boolean
C0027051 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Valvular disease
Item
clinically significant valvular disease
boolean
C3258293 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
women who are pregnant, intend to become pregnant or are breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Medical condition Severe | Study Subject Participation Status Excluded
Item
participants who have severe medical condition(s) that in the view of the investigator prohibits participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Component
Item
participants who have hypersensitivity to the investigational/ reference drug or any of the components in the formulation.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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