ID

39201

Description

Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With Tarka® Fixed Combination in Patients With Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01127139

Link

https://clinicaltrials.gov/show/NCT01127139

Keywords

Versions (1)
  1. 12/10/19 12/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01127139

English

Eligibility Essential Hypertension NCT01127139

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men, women more than 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with uncontrolled essential hypertension eligible to tarka treatment according to local label (bp ≥ 140/90 mmhg)
Description

Essential Hypertension Uncontrolled | Eligibility Tarka Therapy | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0595471
UMLS CUI [2,3]
C0087111
UMLS CUI [3]
C0005824
patients providing oral informed consent (including consent of their medical data to be used for a post marketing observational study) and cooperating with physician
Description

Informed Consent | Consent Use of Patient data | Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1511481
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C2707520
UMLS CUI [3]
C1321605
patients who never received tarka® in the past
Description

Tarka Absent In the past

Data type

boolean

Alias
UMLS CUI [1,1]
C0595471
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1444637
patients whom tarka® will be prescribed according to the labelled indication and dose
Description

Tarka Dosage prescribed

Data type

boolean

Alias
UMLS CUI [1,1]
C0595471
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0278329
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients contraindicated for treatment of tarka® according to the local summary of product characteristics (smpc):
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 Investigational New Drugs | Hypersensitivity Investigational New Drugs inactive ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
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 Artificial cardiac pacemaker Present

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0030163
UMLS CUI [3,3]
C0150312
with sick sinus syndrome - except in patients with a functioning artificial pacemaker
Description

Sick Sinus Syndrome | Exception Artificial cardiac pacemaker Present

Data type

boolean

Alias
UMLS CUI [1]
C0037052
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030163
UMLS CUI [2,3]
C0150312
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 ace inhibitor
Description

Angioedema Associated with Angiotensin-Converting Enzyme Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0002994
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0003015
with severe renal (creatinine clearance < 10 ml/min) or severe liver impairment (cirrhosis with ascites)
Description

Renal Insufficiency Severe | Creatinine clearance measurement | Hepatic impairment Severe | Liver Cirrhosis with Ascites

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0373595
UMLS CUI [3,1]
C0948807
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0332287
UMLS CUI [4,3]
C0003962
pregnant women, women of childbearing potential who are unwilling to use contraception
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
patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
patients currently treated with other fixed antihypertensive combination
Description

Antihypertensive Agents Combination

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0013162
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Similar models

Eligibility Essential Hypertension NCT01127139

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men, women more than 18 years
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension Uncontrolled | Eligibility Tarka Therapy | Blood pressure determination
Item
patients with uncontrolled essential hypertension eligible to tarka treatment according to local label (bp ≥ 140/90 mmhg)
boolean
C0085580 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C0595471 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0005824 (UMLS CUI [3])
Informed Consent | Consent Use of Patient data | Compliance behavior
Item
patients providing oral informed consent (including consent of their medical data to be used for a post marketing observational study) and cooperating with physician
boolean
C0021430 (UMLS CUI [1])
C1511481 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C2707520 (UMLS CUI [2,3])
C1321605 (UMLS CUI [3])
Tarka Absent In the past
Item
patients who never received tarka® in the past
boolean
C0595471 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,3])
Tarka Dosage prescribed
Item
patients whom tarka® will be prescribed according to the labelled indication and dose
boolean
C0595471 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Tarka
Item
patients contraindicated for treatment of tarka® according to the local summary of product characteristics (smpc):
boolean
C1301624 (UMLS CUI [1,1])
C0595471 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs inactive ingredient
Item
hypersensitive to the active substances or to any of the inactive ingredients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (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 Artificial cardiac pacemaker Present
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])
C0030163 (UMLS CUI [3,2])
C0150312 (UMLS CUI [3,3])
Sick Sinus Syndrome | Exception Artificial cardiac pacemaker Present
Item
with sick sinus syndrome - except in patients with a functioning artificial pacemaker
boolean
C0037052 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0030163 (UMLS CUI [2,2])
C0150312 (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 Associated with Angiotensin-Converting Enzyme Inhibitors
Item
with existing history of angioedema associated with administration of an ace inhibitor
boolean
C0002994 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0003015 (UMLS CUI [1,3])
Renal Insufficiency Severe | Creatinine clearance measurement | Hepatic impairment Severe | Liver Cirrhosis with Ascites
Item
with severe renal (creatinine clearance < 10 ml/min) or severe liver impairment (cirrhosis with ascites)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
C0948807 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4,1])
C0332287 (UMLS CUI [4,2])
C0003962 (UMLS CUI [4,3])
Pregnancy | Childbearing Potential Contraceptive methods Unwilling
Item
pregnant women, women of childbearing potential who are unwilling to use contraception
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])
Study Subject Participation Status | Clinical Trial
Item
patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Antihypertensive Agents Combination
Item
patients currently treated with other fixed antihypertensive combination
boolean
C0003364 (UMLS CUI [1,1])
C0013162 (UMLS CUI [1,2])
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