ID

42846

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00240474

Link

http://clinicaltrials.gov/show/NCT00240474

Palavras-chave

Versões (2)
  1. 11/12/2013 11/12/2013 - Martin Dugas
  2. 17/09/2021 17/09/2021 -
Transferido a

17 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NCT00240474 Hypertension

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
aged at least 60 years old
Descrição

age >=60 Years

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
mean SBP >140 mmHg and mean DBP <=95 mmHg
Descrição

mean SBP >140 mmHg and mean DBP <=95 mmHg

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1306620
MedDRA 14.1
10005756
UMLS CUI 2011AA
C1305849
MedDRA 14.1
10005735
24-hour mean ambulatory SBP >125 mmHg
Descrição

24-hour mean ambulatory SBP >125 mmHg

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0444504
SNOMED CT 2011_0131
255586005
UMLS CUI 2011AA
C0439841
UMLS CUI 2011AA
C1306620
MedDRA 14.1
10005756
hypertensive patients not on current antihypertensive therapy or able to stop their current treatment for a period of up to eighteen weeks
Descrição

hypertensive patients not on current antihypertensive therapy or able to stop their current treatment for a period of up to eighteen weeks

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0020538
SNOMED CT 2011_0131
38341003
MedDRA 14.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE 1105E
E13785
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0585941
SNOMED CT 2011_0131
308116003
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C2746065
SNOMED CT 2011_0131
422117008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1948053
willing and able to provide written informed consent
Descrição

willing and able to provide written informed consent

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1576874
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
women of child-bearing potential who are NOT practicing acceptable means of birth control
Descrição

women of child-bearing potential who are NOT practicing acceptable means of birth control

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
known or suspected secondary hypertension
Descrição

known or suspected secondary hypertension

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
C0155616
SNOMED CT 2011_0131
31992008
MedDRA 14.1
10039834
ICD-10-CM Version 2010
I15.9
ICD-9-CM Version 2011
405
mean SBP >=200 mmHg
Descrição

mean SBP >=200 mmHg

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0444504
SNOMED CT 2011_0131
255586005
UMLS CUI 2011AA
C0277884
SNOMED CT 2011_0131
18050000
MedDRA 14.1
10005760
hepatic and/or renal dysfunction as defined by the following laboratory parameters: Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney. Clinically relevant hypokalemia or hyperkalemia. Uncorrected volume or sodium depletion.
Descrição

hepatic and/or renal dysfunction as defined by the following laboratory parameters: Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney. Clinically relevant hypokalemia or hyperkalemia. Uncorrected volume or sodium depletion.

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
UMLS CUI 2011AA
C0151746
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C0449381
SNOMED CT 2011_0131
252116004
UMLS CUI 2011AA
C0856760
SNOMED CT 2011_0131
425414000
MedDRA 14.1
10004579
UMLS CUI 2011AA
C0856759
MedDRA 14.1
10045539
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0022671
SNOMED CT 2011_0131
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
UMLS CUI 2011AA
C0205092
SNOMED CT 2011_0131
66459002
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0020621
SNOMED CT 2011_0131
43339004
MedDRA 14.1
10021015
ICD-10-CM Version 2010
E87.6
ICD-9-CM Version 2011
276.8
CTCAE 1105E
E12327
UMLS CUI 2011AA
C0020461
SNOMED CT 2011_0131
14140009
MedDRA 14.1
10020646
ICD-10-CM Version 2010
E87.5
ICD-9-CM Version 2011
276.7
CTCAE 1105E
E12282
UMLS CUI 2011AA
C0205161
SNOMED CT 2011_0131
263654008
UMLS CUI 2011AA
C0449468
SNOMED CT 2011_0131
118565006
LOINC Version 232
MTHU003070
UMLS CUI 2011AA
C0020625
SNOMED CT 2011_0131
89627008
MedDRA 14.1
10021036
ICD-10-CM Version 2010
E87.1
CTCAE 1105E
E12339
Primary aldosteronism, unspecified
Descrição

primary aldosteronism

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1719312
Hereditary fructose intolerance syndrome
Descrição

hereditary fructose intolerance

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0016751
SNOMED CT 2011_0131
20052008
MedDRA 14.1
10019878
ICD-10-CM Version 2010
E74.12
ICD-9-CM Version 2011
271.2
Biliary Obstruction
Descrição

biliary obstructive disorders

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0400979
SNOMED CT 2011_0131
235918000
patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
Descrição

patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C0002994
SNOMED CT 2011_0131
41291007
MedDRA 14.1
10002424
ICD-10-CM Version 2010
T78.3
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0003015
SNOMED CT 2011_0131
372733002
UMLS CUI 2011AA
C0521942
SNOMED CT 2011_0131
372913009
history of drug or alcohol dependency within the previous six months
Descrição

history of drug or alcohol dependency within the previous six months

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1510472
SNOMED CT 2011_0131
191816009
MedDRA 14.1
10013663
ICD-9-CM Version 2011
304
UMLS CUI 2011AA
C0001973
SNOMED CT 2011_0131
284591009
MedDRA 14.1
10001639
ICD-10-CM Version 2010
F10.2
ICD-9-CM Version 2011
305.01
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
chronic administration of any medication known to affect blood pressure, other than the trial medication
Descrição

chronic administration of any medication known to affect blood pressure, other than the trial medication

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0814606
UMLS CUI 2011AA
C0005823
SNOMED CT 2011_0131
75367002
LOINC Version 232
MTHU008342
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.
Descrição

concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0679823
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0949266
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1561610
UMLS CUI 2011AA
C0009797
UMLS CUI 2011AA
C0021430
symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV)
Descrição

symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV)

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C1319794
SNOMED CT 2011_0131
421704003
MedDRA 14.1
10064080
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery <3 months prior to informed consent
Descrição

unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery <3 months prior to informed consent

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0002965
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C2936173
SNOMED CT 2011_0131
11101003
MedDRA 14.1
10050339
UMLS CUI 2011AA
C0010055
SNOMED CT 2011_0131
232717009
MedDRA 14.1
10011077
ICD-9-CM Version 2011
36.10
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0021430
stroke <6 months prior to informed consent
Descrição

stroke <6 months prior to informed consent

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0021430
sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator
Descrição

sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0750197
SNOMED CT 2011_0131
426525004
MedDRA 14.1
10060730
UMLS CUI 2011AA
C0004238
SNOMED CT 2011_0131
49436004
MedDRA 14.1
10003658
ICD-10-CM Version 2010
I48.0
CTCAE 1105E
E10081
UMLS CUI 2011AA
C0004239
SNOMED CT 2011_0131
5370000
MedDRA 14.1
10003662
ICD-10-CM Version 2010
I48.1
ICD-9-CM Version 2011
427.32
CTCAE 1105E
E10087
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0521095
SNOMED CT 2011_0131
436000
UMLS CUI 2011AA
CL102947
hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
Descrição

hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0700053
SNOMED CT 2011_0131
360465008
MedDRA 14.1
10021230
ICD-10-CM Version 2010
I42.1
UMLS CUI 2011AA
C0019010
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0003507
SNOMED CT 2011_0131
60573004
MedDRA 14.1
10002918
UMLS CUI 2011AA
C0026269
SNOMED CT 2011_0131
79619009
MedDRA 14.1
10027733
insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months
Descrição

insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4:00 AM
Descrição

night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4:00 AM

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0555008
SNOMED CT 2011_0131
276066008
UMLS CUI 2011AA
C0205547
SNOMED CT 2011_0131
50811001
UMLS CUI 2011AA
C0037313
SNOMED CT 2011_0131
258158006
UMLS CUI 2011AA
C0585022
SNOMED CT 2011_0131
307143006
UMLS CUI 2011AA
C0043227
SNOMED CT 2011_0131
261041009
UMLS CUI 2011AA
C0040223
SNOMED CT 2011_0131
410670007
LOINC Version 232
MTHU009151
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0332172
SNOMED CT 2011_0131
27814009
UMLS CUI 2011AA
C0332170
SNOMED CT 2011_0131
73775008
HL7 V3 2006_05
AM
known allergic hypersensitivity to any component of the formulations under investigation
Descrição

known allergic hypersensitivity to any component of the formulations under investigation

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
C0430007
concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as <80% or >120%) during the run-in period
Descrição

concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as <80% or >120%) during the run-in period

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0023870
SNOMED CT 2011_0131
85899009
LOINC Version 232
MTHU004197
UMLS CUI 2011AA
C0008402
SNOMED CT 2011_0131
387408001, 72824008
UMLS CUI 2011AA
C0009279
SNOMED CT 2011_0131
372811005
UMLS CUI 2011AA
C0376405
MedDRA 14.1
10049414
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0439659
SNOMED CT 2011_0131
246062003
LOINC Version 232
MTHU026300
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
current treatment with any antihypertensive agent
Descrição

current treatment with any antihypertensive agent

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C2827774
UMLS CUI 2011AA
C0003364
SNOMED CT 2011_0131
372586001
any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan, amlodipine or hydrochlorothiazide
Descrição

any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan, amlodipine or hydrochlorothiazide

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0205197
SNOMED CT 2011_0131
255594003
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0248719
SNOMED CT 2011_0131
387069000
UMLS CUI 2011AA
C0051696
SNOMED CT 2011_0131
386864001
LOINC Version 232
MTHU013162
UMLS CUI 2011AA
C0020261
SNOMED CT 2011_0131
387525002
LOINC Version 232
MTHU016732
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Similar models

Eligibility

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age >=60 Years
Item
aged at least 60 years old
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
mean SBP >140 mmHg and mean DBP <=95 mmHg
Item
mean SBP >140 mmHg and mean DBP <=95 mmHg
boolean
C1306620 (UMLS CUI 2011AA)
10005756 (MedDRA 14.1)
C1305849 (UMLS CUI 2011AA)
10005735 (MedDRA 14.1)
24-hour mean ambulatory SBP >125 mmHg
Item
24-hour mean ambulatory SBP >125 mmHg
boolean
C0444504 (UMLS CUI 2011AA)
255586005 (SNOMED CT 2011_0131)
C0439841 (UMLS CUI 2011AA)
C1306620 (UMLS CUI 2011AA)
10005756 (MedDRA 14.1)
hypertensive patients not on current antihypertensive therapy or able to stop their current treatment for a period of up to eighteen weeks
Item
hypertensive patients not on current antihypertensive therapy or able to stop their current treatment for a period of up to eighteen weeks
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
C1518422 (UMLS CUI 2011AA)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0585941 (UMLS CUI 2011AA)
308116003 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C2746065 (UMLS CUI 2011AA)
422117008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1948053 (UMLS CUI 2011AA)
willing and able to provide written informed consent
Item
willing and able to provide written informed consent
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1576874 (UMLS CUI 2011AA)
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
women of child-bearing potential who are NOT practicing acceptable means of birth control
Item
women of child-bearing potential who are NOT practicing acceptable means of birth control
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
known or suspected secondary hypertension
Item
known or suspected secondary hypertension
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0155616 (UMLS CUI 2011AA)
31992008 (SNOMED CT 2011_0131)
10039834 (MedDRA 14.1)
I15.9 (ICD-10-CM Version 2010)
405 (ICD-9-CM Version 2011)
mean SBP >=200 mmHg
Item
mean SBP >=200 mmHg
boolean
C0444504 (UMLS CUI 2011AA)
255586005 (SNOMED CT 2011_0131)
C0277884 (UMLS CUI 2011AA)
18050000 (SNOMED CT 2011_0131)
10005760 (MedDRA 14.1)
hepatic and/or renal dysfunction as defined by the following laboratory parameters: Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney. Clinically relevant hypokalemia or hyperkalemia. Uncorrected volume or sodium depletion.
Item
hepatic and/or renal dysfunction as defined by the following laboratory parameters: Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney. Clinically relevant hypokalemia or hyperkalemia. Uncorrected volume or sodium depletion.
boolean
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C0151746 (UMLS CUI 2011AA)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C0449381 (UMLS CUI 2011AA)
252116004 (SNOMED CT 2011_0131)
C0856760 (UMLS CUI 2011AA)
425414000 (SNOMED CT 2011_0131)
10004579 (MedDRA 14.1)
C0856759 (UMLS CUI 2011AA)
10045539 (MedDRA 14.1)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
C0205092 (UMLS CUI 2011AA)
66459002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0020621 (UMLS CUI 2011AA)
43339004 (SNOMED CT 2011_0131)
10021015 (MedDRA 14.1)
E87.6 (ICD-10-CM Version 2010)
276.8 (ICD-9-CM Version 2011)
E12327 (CTCAE 1105E)
C0020461 (UMLS CUI 2011AA)
14140009 (SNOMED CT 2011_0131)
10020646 (MedDRA 14.1)
E87.5 (ICD-10-CM Version 2010)
276.7 (ICD-9-CM Version 2011)
E12282 (CTCAE 1105E)
C0205161 (UMLS CUI 2011AA)
263654008 (SNOMED CT 2011_0131)
C0449468 (UMLS CUI 2011AA)
118565006 (SNOMED CT 2011_0131)
MTHU003070 (LOINC Version 232)
C0020625 (UMLS CUI 2011AA)
89627008 (SNOMED CT 2011_0131)
10021036 (MedDRA 14.1)
E87.1 (ICD-10-CM Version 2010)
E12339 (CTCAE 1105E)
primary aldosteronism
Item
Primary aldosteronism, unspecified
boolean
C1719312 (UMLS CUI 2011AA)
hereditary fructose intolerance
Item
Hereditary fructose intolerance syndrome
boolean
C0016751 (UMLS CUI 2011AA)
20052008 (SNOMED CT 2011_0131)
10019878 (MedDRA 14.1)
E74.12 (ICD-10-CM Version 2010)
271.2 (ICD-9-CM Version 2011)
biliary obstructive disorders
Item
Biliary Obstruction
boolean
C0400979 (UMLS CUI 2011AA)
235918000 (SNOMED CT 2011_0131)
patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
Item
patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0002994 (UMLS CUI 2011AA)
41291007 (SNOMED CT 2011_0131)
10002424 (MedDRA 14.1)
T78.3 (ICD-10-CM Version 2010)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0003015 (UMLS CUI 2011AA)
372733002 (SNOMED CT 2011_0131)
C0521942 (UMLS CUI 2011AA)
372913009 (SNOMED CT 2011_0131)
history of drug or alcohol dependency within the previous six months
Item
history of drug or alcohol dependency within the previous six months
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1510472 (UMLS CUI 2011AA)
191816009 (SNOMED CT 2011_0131)
10013663 (MedDRA 14.1)
304 (ICD-9-CM Version 2011)
C0001973 (UMLS CUI 2011AA)
284591009 (SNOMED CT 2011_0131)
10001639 (MedDRA 14.1)
F10.2 (ICD-10-CM Version 2010)
305.01 (ICD-9-CM Version 2011)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
chronic administration of any medication known to affect blood pressure, other than the trial medication
Item
chronic administration of any medication known to affect blood pressure, other than the trial medication
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0814606 (UMLS CUI 2011AA)
C0005823 (UMLS CUI 2011AA)
75367002 (SNOMED CT 2011_0131)
MTHU008342 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.
Item
concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0949266 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1561610 (UMLS CUI 2011AA)
C0009797 (UMLS CUI 2011AA)
C0021430 (UMLS CUI 2011AA)
symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV)
Item
symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV)
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery <3 months prior to informed consent
Item
unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery <3 months prior to informed consent
boolean
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C2936173 (UMLS CUI 2011AA)
11101003 (SNOMED CT 2011_0131)
10050339 (MedDRA 14.1)
C0010055 (UMLS CUI 2011AA)
232717009 (SNOMED CT 2011_0131)
10011077 (MedDRA 14.1)
36.10 (ICD-9-CM Version 2011)
C0038895 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0021430 (UMLS CUI 2011AA)
stroke <6 months prior to informed consent
Item
stroke <6 months prior to informed consent
boolean
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0021430 (UMLS CUI 2011AA)
sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator
Item
sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator
boolean
C0750197 (UMLS CUI 2011AA)
426525004 (SNOMED CT 2011_0131)
10060730 (MedDRA 14.1)
C0004238 (UMLS CUI 2011AA)
49436004 (SNOMED CT 2011_0131)
10003658 (MedDRA 14.1)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE 1105E)
C0004239 (UMLS CUI 2011AA)
5370000 (SNOMED CT 2011_0131)
10003662 (MedDRA 14.1)
I48.1 (ICD-10-CM Version 2010)
427.32 (ICD-9-CM Version 2011)
E10087 (CTCAE 1105E)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0521095 (UMLS CUI 2011AA)
436000 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
Item
hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
boolean
C0700053 (UMLS CUI 2011AA)
360465008 (SNOMED CT 2011_0131)
10021230 (MedDRA 14.1)
I42.1 (ICD-10-CM Version 2010)
C0019010 (UMLS CUI 2011AA)
C2347946 (UMLS CUI 2011AA)
C0003507 (UMLS CUI 2011AA)
60573004 (SNOMED CT 2011_0131)
10002918 (MedDRA 14.1)
C0026269 (UMLS CUI 2011AA)
79619009 (SNOMED CT 2011_0131)
10027733 (MedDRA 14.1)
insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months
Item
insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months
boolean
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4:00 AM
Item
night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4:00 AM
boolean
C0555008 (UMLS CUI 2011AA)
276066008 (SNOMED CT 2011_0131)
C0205547 (UMLS CUI 2011AA)
50811001 (SNOMED CT 2011_0131)
C0037313 (UMLS CUI 2011AA)
258158006 (SNOMED CT 2011_0131)
C0585022 (UMLS CUI 2011AA)
307143006 (SNOMED CT 2011_0131)
C0043227 (UMLS CUI 2011AA)
261041009 (SNOMED CT 2011_0131)
C0040223 (UMLS CUI 2011AA)
410670007 (SNOMED CT 2011_0131)
MTHU009151 (LOINC Version 232)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0332172 (UMLS CUI 2011AA)
27814009 (SNOMED CT 2011_0131)
C0332170 (UMLS CUI 2011AA)
73775008 (SNOMED CT 2011_0131)
AM (HL7 V3 2006_05)
known allergic hypersensitivity to any component of the formulations under investigation
Item
known allergic hypersensitivity to any component of the formulations under investigation
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1705248 (UMLS CUI 2011AA)
C0430007 (UMLS CUI 2011AA)
concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as <80% or >120%) during the run-in period
Item
concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as <80% or >120%) during the run-in period
boolean
CL415222 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0023870 (UMLS CUI 2011AA)
85899009 (SNOMED CT 2011_0131)
MTHU004197 (LOINC Version 232)
C0008402 (UMLS CUI 2011AA)
387408001, 72824008 (SNOMED CT 2011_0131)
C0009279 (UMLS CUI 2011AA)
372811005 (SNOMED CT 2011_0131)
C0376405 (UMLS CUI 2011AA)
10049414 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439659 (UMLS CUI 2011AA)
246062003 (SNOMED CT 2011_0131)
MTHU026300 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
current treatment with any antihypertensive agent
Item
current treatment with any antihypertensive agent
boolean
C2827774 (UMLS CUI 2011AA)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan, amlodipine or hydrochlorothiazide
Item
any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan, amlodipine or hydrochlorothiazide
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
CL102947 (UMLS CUI 2011AA)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0248719 (UMLS CUI 2011AA)
387069000 (SNOMED CT 2011_0131)
C0051696 (UMLS CUI 2011AA)
386864001 (SNOMED CT 2011_0131)
MTHU013162 (LOINC Version 232)
C0020261 (UMLS CUI 2011AA)
387525002 (SNOMED CT 2011_0131)
MTHU016732 (LOINC Version 232)
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