ID

29882

Description

Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00413413

Link

https://clinicaltrials.gov/show/NCT00413413

Keywords

Versions (1)
  1. 4/25/18 4/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 25, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00413413

English

Eligibility Hypertension NCT00413413

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatients >= 18 years and < 86 years
Description

Outpatients | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with essential diastolic hypertension
Description

Essential diastolic hypertension

Data type

boolean

Alias
UMLS CUI [1]
C3694763
at visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmhg and < 10 mmhg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmhg
Description

Visit Number | Sitting diastolic blood pressure mean | Antihypertensive Agents

Data type

boolean

Alias
UMLS CUI [1]
C1549755
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3]
C0003364
at visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmhg and < 100 mmhg
Description

Visit Number | Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C1549755
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
at visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmhg and < 110 mmhg
Description

Visit Number | Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C1549755
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension >= 180/110 mmhg
Description

Hypertension, severe

Data type

boolean

Alias
UMLS CUI [1]
C4013784
known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
Description

Medical contraindication Valsartan | Medical contraindication Suspected Valsartan | Medical contraindication Amlodipine | Medical contraindication Suspected Amlodipine | Hypersensitivity Valsartan | Amlodipine allergy | Hypersensitivity Pharmaceutical Preparations Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0216784
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0216784
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0051696
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0051696
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0216784
UMLS CUI [6]
C0570921
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0013227
UMLS CUI [7,3]
C2348205
inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to visit 2
Description

Antihypertensive Agents Unable to discontinue

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1548265
history of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
Description

Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Revascularization

Data type

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0581603
malignant hypertension
Description

Malignant Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020540
all patients with type i diabetes and those patients with type 2 diabetes who are not well controlled based on the investigator's clinical judgment
Description

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
pregnant or nursing women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of heart failure
Description

Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
angina pectoris
Description

Angina Pectoris

Data type

boolean

Alias
UMLS CUI [1]
C0002962
second or third degree heart block
Description

Second degree atrioventricular block | Complete atrioventricular block

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
life threatening or symptomatic arrhythmias
Description

Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0741212
clinically significant valvular heart disease
Description

Heart valve disease

Data type

boolean

Alias
UMLS CUI [1]
C0018824
evidence of a secondary form of hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
known or moderate malignant retinopathy
Description

Retinal Disease Malignant | Retinal Disease Malignant Moderate

Data type

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0205282
UMLS CUI [2,1]
C0035309
UMLS CUI [2,2]
C0205282
UMLS CUI [2,3]
C0205081
evidence of hepatic disease
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
evidence of renal impairment
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
other protocol-defined exclusion criteria may apply.
Description

Exclusion Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hypertension NCT00413413

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male or female outpatients >= 18 years and < 86 years
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Essential diastolic hypertension
Item
patients with essential diastolic hypertension
boolean
C3694763 (UMLS CUI [1])
Visit Number | Sitting diastolic blood pressure mean | Antihypertensive Agents
Item
at visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmhg and < 10 mmhg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmhg
boolean
C1549755 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3])
Visit Number | Sitting diastolic blood pressure mean
Item
at visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmhg and < 100 mmhg
boolean
C1549755 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Visit Number | Sitting diastolic blood pressure mean
Item
at visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmhg and < 110 mmhg
boolean
C1549755 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe
Item
severe hypertension >= 180/110 mmhg
boolean
C4013784 (UMLS CUI [1])
Medical contraindication Valsartan | Medical contraindication Suspected Valsartan | Medical contraindication Amlodipine | Medical contraindication Suspected Amlodipine | Hypersensitivity Valsartan | Amlodipine allergy | Hypersensitivity Pharmaceutical Preparations Similar
Item
known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
boolean
C1301624 (UMLS CUI [1,1])
C0216784 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0216784 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0051696 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0051696 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0216784 (UMLS CUI [5,2])
C0570921 (UMLS CUI [6])
C0020517 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
C2348205 (UMLS CUI [7,3])
Antihypertensive Agents Unable to discontinue
Item
inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to visit 2
boolean
C0003364 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Revascularization
Item
history of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0581603 (UMLS CUI [5])
Malignant Hypertension
Item
malignant hypertension
boolean
C0020540 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
all patients with type i diabetes and those patients with type 2 diabetes who are not well controlled based on the investigator's clinical judgment
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart failure
Item
history of heart failure
boolean
C0018801 (UMLS CUI [1])
Angina Pectoris
Item
angina pectoris
boolean
C0002962 (UMLS CUI [1])
Second degree atrioventricular block | Complete atrioventricular block
Item
second or third degree heart block
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC
Item
life threatening or symptomatic arrhythmias
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0741212 (UMLS CUI [2])
Heart valve disease
Item
clinically significant valvular heart disease
boolean
C0018824 (UMLS CUI [1])
Secondary hypertension
Item
evidence of a secondary form of hypertension
boolean
C0155616 (UMLS CUI [1])
Retinal Disease Malignant | Retinal Disease Malignant Moderate
Item
known or moderate malignant retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
Liver disease
Item
evidence of hepatic disease
boolean
C0023895 (UMLS CUI [1])
Renal Insufficiency
Item
evidence of renal impairment
boolean
C1565489 (UMLS CUI [1])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria may apply.
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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