ID

29356

Descripción

Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01001572

Link

https://clinicaltrials.gov/show/NCT01001572

Palabras clave

Versiones (1)
  1. 20/3/18 20/3/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de marzo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01001572

Inglés

Eligibility Essential Hypertension NCT01001572

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must give written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
male or female ages 18 or older and less than 86 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed as having essential diastolic hypertension, as follows:
Descripción

Essential diastolic hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3694763
visit 2/single-blind run-in entry, all participants must have a msdbp ≥ 95 mmhg and < 100 mmhg
Descripción

Single-Blind Method | Sitting diastolic blood pressure mean

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0037181
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
at visit 3/core double-blind treatment period entry, all patients must have a msdbp >=90 mmhg and <110 mmhg
Descripción

Double-Blind Method | Sitting diastolic blood pressure mean

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013072
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension
Descripción

Hypertension, severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4013784
evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, cushing's disease, pheochromocytoma or polycystic kidney disease )
Descripción

Secondary hypertension | Aortic coarctation | Hyperaldosteronism | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Cushing's disease | Pheochromocytoma | Polycystic Kidney Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0003492
UMLS CUI [3]
C0020428
UMLS CUI [4]
C0856759
UMLS CUI [5]
C0856760
UMLS CUI [6]
C0221406
UMLS CUI [7]
C0031511
UMLS CUI [8]
C0022680
malignant hypertension
Descripción

Malignant Hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020540
administration of any agent indicated for the treatment of hypertension after visit 1
Descripción

Antihypertensive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003364
known moderate or malignant retinopathy.
Descripción

Retinal Disease Moderate | Retinal Disease Malignant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0035309
UMLS CUI [2,2]
C0205282
known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin ii receptor blockers (arbs), calcium channel blockers (ccbs), or to drugs with similar chemical structures
Descripción

Medical contraindication Angiotensin II receptor antagonist | Medical contraindication Suspected Angiotensin II receptor antagonist | Allergy to angiotensin II receptor antagonist | Medical contraindication Calcium Channel Blockers | Medical contraindication Suspected Calcium Channel Blockers | Calcium-channel blocker allergy | Medical contraindication Pharmaceutical Preparations Chemical Structure Similar | Medical contraindication Suspected Pharmaceutical Preparations Chemical Structure Similar | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0521942
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0521942
UMLS CUI [3]
C2585204
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0006684
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0750491
UMLS CUI [5,3]
C0006684
UMLS CUI [6]
C0570913
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0013227
UMLS CUI [7,3]
C0220807
UMLS CUI [7,4]
C2348205
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0750491
UMLS CUI [8,3]
C0013227
UMLS CUI [8,4]
C0220807
UMLS CUI [8,5]
C2348205
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0013227
UMLS CUI [9,3]
C0220807
UMLS CUI [9,4]
C2348205
history of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
Descripción

Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Revascularization Type All | Angina Pectoris Type Any | Angina, Unstable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0581603
UMLS CUI [5,2]
C0332307
UMLS CUI [5,3]
C0444868
UMLS CUI [6,1]
C0002962
UMLS CUI [6,2]
C0332307
UMLS CUI [6,3]
C1552551
UMLS CUI [7]
C0002965
history of heart failure grade ii-iv according to new york heart association (nyha) classification
Descripción

Heart failure New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia
Descripción

Second degree atrioventricular block Independent of Artificial cardiac pacemaker | Complete atrioventricular block Independent of Artificial cardiac pacemaker | Second degree atrioventricular block Independent of Cardiac Arrhythmia Life Threatening | Complete atrioventricular block Independent of Cardiac Arrhythmia Life Threatening | Second degree atrioventricular block Independent of ARRHYTHMIA SYMPTOMATIC | Complete atrioventricular block Independent of ARRHYTHMIA SYMPTOMATIC

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0264906
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0030163
UMLS CUI [2,1]
C0151517
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0030163
UMLS CUI [3,1]
C0264906
UMLS CUI [3,2]
C0332291
UMLS CUI [3,3]
C0003811
UMLS CUI [3,4]
C2826244
UMLS CUI [4,1]
C0151517
UMLS CUI [4,2]
C0332291
UMLS CUI [4,3]
C0003811
UMLS CUI [4,4]
C2826244
UMLS CUI [5,1]
C0264906
UMLS CUI [5,2]
C0332291
UMLS CUI [5,3]
C0741212
UMLS CUI [6,1]
C0151517
UMLS CUI [6,2]
C0332291
UMLS CUI [6,3]
C0741212
other protocol-defined inclusion/exclusion criteria may apply
Descripción

Clinical Trial Eligibility Criteria Study Protocol

Tipo de datos

boolean

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

Eligibility Essential Hypertension NCT01001572

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patients must give written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female ages 18 or older and less than 86 years
boolean
C0001779 (UMLS CUI [1])
Essential diastolic hypertension
Item
diagnosed as having essential diastolic hypertension, as follows:
boolean
C3694763 (UMLS CUI [1])
Single-Blind Method | Sitting diastolic blood pressure mean
Item
visit 2/single-blind run-in entry, all participants must have a msdbp ≥ 95 mmhg and < 100 mmhg
boolean
C0037181 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Double-Blind Method | Sitting diastolic blood pressure mean
Item
at visit 3/core double-blind treatment period entry, all patients must have a msdbp >=90 mmhg and <110 mmhg
boolean
C0013072 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe
Item
severe hypertension
boolean
C4013784 (UMLS CUI [1])
Secondary hypertension | Aortic coarctation | Hyperaldosteronism | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Cushing's disease | Pheochromocytoma | Polycystic Kidney Diseases
Item
evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, cushing's disease, pheochromocytoma or polycystic kidney disease )
boolean
C0155616 (UMLS CUI [1])
C0003492 (UMLS CUI [2])
C0020428 (UMLS CUI [3])
C0856759 (UMLS CUI [4])
C0856760 (UMLS CUI [5])
C0221406 (UMLS CUI [6])
C0031511 (UMLS CUI [7])
C0022680 (UMLS CUI [8])
Malignant Hypertension
Item
malignant hypertension
boolean
C0020540 (UMLS CUI [1])
Antihypertensive Agents
Item
administration of any agent indicated for the treatment of hypertension after visit 1
boolean
C0003364 (UMLS CUI [1])
Retinal Disease Moderate | Retinal Disease Malignant
Item
known moderate or malignant retinopathy.
boolean
C0035309 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
Medical contraindication Angiotensin II receptor antagonist | Medical contraindication Suspected Angiotensin II receptor antagonist | Allergy to angiotensin II receptor antagonist | Medical contraindication Calcium Channel Blockers | Medical contraindication Suspected Calcium Channel Blockers | Calcium-channel blocker allergy | Medical contraindication Pharmaceutical Preparations Chemical Structure Similar | Medical contraindication Suspected Pharmaceutical Preparations Chemical Structure Similar | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar
Item
known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin ii receptor blockers (arbs), calcium channel blockers (ccbs), or to drugs with similar chemical structures
boolean
C1301624 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0521942 (UMLS CUI [2,3])
C2585204 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0006684 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C0006684 (UMLS CUI [5,3])
C0570913 (UMLS CUI [6])
C1301624 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
C0220807 (UMLS CUI [7,3])
C2348205 (UMLS CUI [7,4])
C1301624 (UMLS CUI [8,1])
C0750491 (UMLS CUI [8,2])
C0013227 (UMLS CUI [8,3])
C0220807 (UMLS CUI [8,4])
C2348205 (UMLS CUI [8,5])
C0020517 (UMLS CUI [9,1])
C0013227 (UMLS CUI [9,2])
C0220807 (UMLS CUI [9,3])
C2348205 (UMLS CUI [9,4])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Revascularization Type All | Angina Pectoris Type Any | Angina, Unstable
Item
history of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0581603 (UMLS CUI [5,1])
C0332307 (UMLS CUI [5,2])
C0444868 (UMLS CUI [5,3])
C0002962 (UMLS CUI [6,1])
C0332307 (UMLS CUI [6,2])
C1552551 (UMLS CUI [6,3])
C0002965 (UMLS CUI [7])
Heart failure New York Heart Association Classification
Item
history of heart failure grade ii-iv according to new york heart association (nyha) classification
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Second degree atrioventricular block Independent of Artificial cardiac pacemaker | Complete atrioventricular block Independent of Artificial cardiac pacemaker | Second degree atrioventricular block Independent of Cardiac Arrhythmia Life Threatening | Complete atrioventricular block Independent of Cardiac Arrhythmia Life Threatening | Second degree atrioventricular block Independent of ARRHYTHMIA SYMPTOMATIC | Complete atrioventricular block Independent of ARRHYTHMIA SYMPTOMATIC
Item
second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia
boolean
C0264906 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0030163 (UMLS CUI [1,3])
C0151517 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0030163 (UMLS CUI [2,3])
C0264906 (UMLS CUI [3,1])
C0332291 (UMLS CUI [3,2])
C0003811 (UMLS CUI [3,3])
C2826244 (UMLS CUI [3,4])
C0151517 (UMLS CUI [4,1])
C0332291 (UMLS CUI [4,2])
C0003811 (UMLS CUI [4,3])
C2826244 (UMLS CUI [4,4])
C0264906 (UMLS CUI [5,1])
C0332291 (UMLS CUI [5,2])
C0741212 (UMLS CUI [5,3])
C0151517 (UMLS CUI [6,1])
C0332291 (UMLS CUI [6,2])
C0741212 (UMLS CUI [6,3])
Clinical Trial 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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