Eligibility NCT00240474 Hypertension

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

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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