Eligibility Hypertension NCT01079195

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients of either gender (more than 18 years of age), with established diagnosis of essential hypertension (systolic blood pressure/ diastolic blood pressure greater than 140/90 mmhg)
Beschrijving

Adult | Age | Essential Hypertension | Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0085580
UMLS CUI [4]
C0871470
UMLS CUI [5]
C0428883
patients not controlled on single-drug therapy and decision was made to introduce tarka
Beschrijving

Pharmacotherapy Singular Absent | Decision Introduce Tarka

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0679006
UMLS CUI [2,2]
C1292748
UMLS CUI [2,3]
C0595471
patients with a high risk of developing diabetes mellitus (defined according british medical society guidelines) with at least one of the following symptoms:
Beschrijving

High risk of Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0011849
positive family history of diabetes or
Beschrijving

Family history of diabetes mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C1313937
obesity defined by a body mass index (bmi) greater than 30 kg/m^2 or a waist circumference greater than 102 cm (males) or greater than 88 cm (females) or
Beschrijving

Obesity | Body mass index | Waist Circumference | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0028754
UMLS CUI [2]
C1305855
UMLS CUI [3]
C0455829
UMLS CUI [4]
C0079399
impaired fasting plasma glucose (fpg) levels of 6.1 to 7.0 mmol/l (100-126 mg/dl)
Beschrijving

Plasma fasting glucose level Impaired

Datatype

boolean

Alias
UMLS CUI [1,1]
C0583513
UMLS CUI [1,2]
C0221099
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with known or established type 2 diabetes mellitus
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
the use of tarka is contraindicated in the following patients:
Beschrijving

Medical contraindication Tarka

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0595471
hypersensitive to the active substances or to any of the inactive ingredients
Beschrijving

Hypersensitivity Tarka | Hypersensitivity Tarka Inactive ingredient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0595471
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0595471
UMLS CUI [2,3]
C1552019
with cardiogenic shock
Beschrijving

Shock, Cardiogenic

Datatype

boolean

Alias
UMLS CUI [1]
C0036980
with second and third degree atrioventricular block - except in patients with a functioning artificial pacemaker
Beschrijving

Second degree atrioventricular block | Complete atrioventricular block | Exception Patients Artificial cardiac pacemaker

Datatype

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0030705
UMLS CUI [3,3]
C0030163
with sick sinus syndrome - except in patients with a functioning artificial pacemaker
Beschrijving

Sick Sinus Syndrome | Exception Patients Artificial cardiac pacemaker

Datatype

boolean

Alias
UMLS CUI [1]
C0037052
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C0030163
with atrial fibrillation/flutter and concomitant wolff-parkinson-white syndrome
Beschrijving

Atrial Fibrillation | Atrial Flutter | Wolff-Parkinson-White Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0004239
UMLS CUI [3]
C0043202
with existing history of angioedema associated with administration of an angiotensin-converting enzyme (ace) inhibitor
Beschrijving

Angioedema | Angiotensin-Converting Enzyme Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C0002994
UMLS CUI [2]
C0003015
with severe renal or severe liver impairment
Beschrijving

Renal Insufficiency Severe | Hepatic impairment Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C0205082
in pregnant women (women of childbearing potential who are unwilling to use contraception should not be included)
Beschrijving

Pregnancy | Childbearing Potential Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
lactating women
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147

Similar models

Eligibility Hypertension NCT01079195

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Essential Hypertension | Systolic Pressure | Diastolic blood pressure
Item
adult patients of either gender (more than 18 years of age), with established diagnosis of essential hypertension (systolic blood pressure/ diastolic blood pressure greater than 140/90 mmhg)
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0085580 (UMLS CUI [3])
C0871470 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
Pharmacotherapy Singular Absent | Decision Introduce Tarka
Item
patients not controlled on single-drug therapy and decision was made to introduce tarka
boolean
C0013216 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0679006 (UMLS CUI [2,1])
C1292748 (UMLS CUI [2,2])
C0595471 (UMLS CUI [2,3])
High risk of Diabetes Mellitus
Item
patients with a high risk of developing diabetes mellitus (defined according british medical society guidelines) with at least one of the following symptoms:
boolean
C0332167 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Family history of diabetes mellitus
Item
positive family history of diabetes or
boolean
C1313937 (UMLS CUI [1])
Obesity | Body mass index | Waist Circumference | Gender
Item
obesity defined by a body mass index (bmi) greater than 30 kg/m^2 or a waist circumference greater than 102 cm (males) or greater than 88 cm (females) or
boolean
C0028754 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
C0455829 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Plasma fasting glucose level Impaired
Item
impaired fasting plasma glucose (fpg) levels of 6.1 to 7.0 mmol/l (100-126 mg/dl)
boolean
C0583513 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with known or established type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Medical contraindication Tarka
Item
the use of tarka is contraindicated in the following patients:
boolean
C1301624 (UMLS CUI [1,1])
C0595471 (UMLS CUI [1,2])
Hypersensitivity Tarka | Hypersensitivity Tarka Inactive ingredient
Item
hypersensitive to the active substances or to any of the inactive ingredients
boolean
C0020517 (UMLS CUI [1,1])
C0595471 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0595471 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
Shock, Cardiogenic
Item
with cardiogenic shock
boolean
C0036980 (UMLS CUI [1])
Second degree atrioventricular block | Complete atrioventricular block | Exception Patients Artificial cardiac pacemaker
Item
with second and third degree atrioventricular block - except in patients with a functioning artificial pacemaker
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0030705 (UMLS CUI [3,2])
C0030163 (UMLS CUI [3,3])
Sick Sinus Syndrome | Exception Patients Artificial cardiac pacemaker
Item
with sick sinus syndrome - except in patients with a functioning artificial pacemaker
boolean
C0037052 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0030163 (UMLS CUI [2,3])
Atrial Fibrillation | Atrial Flutter | Wolff-Parkinson-White Syndrome
Item
with atrial fibrillation/flutter and concomitant wolff-parkinson-white syndrome
boolean
C0004238 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
C0043202 (UMLS CUI [3])
Angioedema | Angiotensin-Converting Enzyme Inhibitors
Item
with existing history of angioedema associated with administration of an angiotensin-converting enzyme (ace) inhibitor
boolean
C0002994 (UMLS CUI [1])
C0003015 (UMLS CUI [2])
Renal Insufficiency Severe | Hepatic impairment Severe
Item
with severe renal or severe liver impairment
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0948807 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pregnancy | Childbearing Potential Contraceptive methods Unwilling
Item
in pregnant women (women of childbearing potential who are unwilling to use contraception should not be included)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Breast Feeding
Item
lactating women
boolean
C0006147 (UMLS CUI [1])