ID

30037

Description

Effectiveness and Tolerability of Tarka® in the Treatment of Hypertensive Patients With High Risk of Developing Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01079195

Link

https://clinicaltrials.gov/show/NCT01079195

Keywords

Versions (1)
  1. 5/4/18 5/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01079195

English

Eligibility Hypertension NCT01079195

1 forms  
Inclusion Criteria
Description

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)
Description

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

Data type

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
Description

Pharmacotherapy Singular Absent | Decision Introduce Tarka

Data type

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:
Description

High risk of Diabetes Mellitus

Data type

boolean

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

Family history of diabetes mellitus

Data type

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
Description

Obesity | Body mass index | Waist Circumference | Gender

Data type

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)
Description

Plasma fasting glucose level Impaired

Data type

boolean

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

Exclusion Criteria

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

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

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

Medical contraindication Tarka

Data type

boolean

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

Hypersensitivity Tarka | Hypersensitivity Tarka Inactive ingredient

Data type

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
Description

Shock, Cardiogenic

Data type

boolean

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

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

Data type

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
Description

Sick Sinus Syndrome | Exception Patients Artificial cardiac pacemaker

Data type

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
Description

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

Data type

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
Description

Angioedema | Angiotensin-Converting Enzyme Inhibitors

Data type

boolean

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

Renal Insufficiency Severe | Hepatic impairment Severe

Data type

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)
Description

Pregnancy | Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

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

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Hypertension NCT01079195

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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