ID

40086

Description

Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine; ODM derived from: https://clinicaltrials.gov/show/NCT01613209

Link

https://clinicaltrials.gov/show/NCT01613209

Keywords

Versions (1)
  1. 3/11/20 3/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 11, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01613209

English

Eligibility Hypertension NCT01613209

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
essential hypertension, i. e. systolic opm >=140 mmhg at screening and >=160 mmhg after two weeks wash-out
Description

Essential Hypertension | Systolic Pressure Screening | Systolic Pressure Post Washout

Data type

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C1710032
UMLS CUI [3,1]
C0871470
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1710661
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
systolic office bp > 180 mm hg at screening visit
Description

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
known hypertensive retinopathy giii or iv
Description

Hypertensive Retinopathy Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0152132
UMLS CUI [1,2]
C0441800
recent (< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
Description

Myocardial Infarction | Indication Coronary revascularisation | Indication Peripheral revascularisation

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0877341
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C1096418
type i diabetes or poorly controlled (hba1c >= 8) type ii diabetes
Description

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
UMLS CUI [3]
C0474680
chronic heart failure nyha iii or iv
Description

Chronic heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C1275491
prior stroke or tia
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
creatinine clearance < 60 ml/min or condition after kidney transplant
Description

Creatinine clearance measurement | Condition Post Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0022671
moderately or severely impaired liver function (alt or ast or bilirubin more than double normal value)
Description

Liver Dysfunction Moderate | Liver Dysfunction Severe | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0741494
women of childbearing potential without highly effective contraception, pregnant or breastfeeding women
Description

Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
concomitant therapy with lithium
Description

Lithium therapy

Data type

boolean

Alias
UMLS CUI [1]
C0204592
hemodynamically relevant mitral or aortic valve stenosis (>= ii°) or hypertrophic obstructive cardiomyopathy
Description

Mitral Valve Stenosis | Aortic Valve Stenosis | Hypertrophic Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0026269
UMLS CUI [2]
C0003507
UMLS CUI [3]
C0007194
concomitant therapy with strong cyp3a4 inhibitors or inductors
Description

CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850041
UMLS CUI [2,2]
C0442821
african patients
Description

Patients African

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0027567
concomitant severe psychiatric condition that might impair proper intake of study medication
Description

Severe Mental Disorders Impairing Intake Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C4046029
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C1512806
UMLS CUI [1,4]
C0013230
life expectancy < 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
night shift workers
Description

Night shift worker

Data type

boolean

Alias
UMLS CUI [1]
C0555008
known other mandatory indication for treatment with antihypertensive medications
Description

Indication Antihypertensive therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0585941
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Similar models

Eligibility Hypertension NCT01613209

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension | Systolic Pressure Screening | Systolic Pressure Post Washout
Item
essential hypertension, i. e. systolic opm >=140 mmhg at screening and >=160 mmhg after two weeks wash-out
boolean
C0085580 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C1710032 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1710661 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure
Item
systolic office bp > 180 mm hg at screening visit
boolean
C0871470 (UMLS CUI [1])
Hypertensive Retinopathy Grade
Item
known hypertensive retinopathy giii or iv
boolean
C0152132 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Myocardial Infarction | Indication Coronary revascularisation | Indication Peripheral revascularisation
Item
recent (< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
boolean
C0027051 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0877341 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C1096418 (UMLS CUI [3,2])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Hemoglobin A1c measurement
Item
type i diabetes or poorly controlled (hba1c >= 8) type ii diabetes
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0474680 (UMLS CUI [3])
Chronic heart failure New York Heart Association Classification
Item
chronic heart failure nyha iii or iv
boolean
C0264716 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
prior stroke or tia
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Creatinine clearance measurement | Condition Post Kidney Transplantation
Item
creatinine clearance < 60 ml/min or condition after kidney transplant
boolean
C0373595 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0022671 (UMLS CUI [2,3])
Liver Dysfunction Moderate | Liver Dysfunction Severe | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
moderately or severely impaired liver function (alt or ast or bilirubin more than double normal value)
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0741494 (UMLS CUI [5])
Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding
Item
women of childbearing potential without highly effective contraception, pregnant or breastfeeding women
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Lithium therapy
Item
concomitant therapy with lithium
boolean
C0204592 (UMLS CUI [1])
Mitral Valve Stenosis | Aortic Valve Stenosis | Hypertrophic Cardiomyopathy
Item
hemodynamically relevant mitral or aortic valve stenosis (>= ii°) or hypertrophic obstructive cardiomyopathy
boolean
C0026269 (UMLS CUI [1])
C0003507 (UMLS CUI [2])
C0007194 (UMLS CUI [3])
CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong
Item
concomitant therapy with strong cyp3a4 inhibitors or inductors
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
Patients African
Item
african patients
boolean
C0030705 (UMLS CUI [1,1])
C0027567 (UMLS CUI [1,2])
Severe Mental Disorders Impairing Intake Investigational New Drugs
Item
concomitant severe psychiatric condition that might impair proper intake of study medication
boolean
C4046029 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Life Expectancy
Item
life expectancy < 6 months
boolean
C0023671 (UMLS CUI [1])
Night shift worker
Item
night shift workers
boolean
C0555008 (UMLS CUI [1])
Indication Antihypertensive therapy
Item
known other mandatory indication for treatment with antihypertensive medications
boolean
C3146298 (UMLS CUI [1,1])
C0585941 (UMLS CUI [1,2])
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