ID

39212

Description

Antihypertensive Effect of Rostafuroxin Compared With Losartan in Hypertensive Patients Bearing Specified Gene Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT01320397

Link

https://clinicaltrials.gov/show/NCT01320397

Keywords

Versions (1)
  1. 12/11/19 12/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01320397

English

Eligibility Essential Hypertension NCT01320397

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signature of a written informed consent, included informed consent on genotype analysis.
Description

Informed Consent | Informed Consent Genotype determination

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1285573
naive hypertensive patient (new diagnosed patient, never treated before).
Description

Patient Hypertensive Newly Diagnosed | Patient untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0857121
UMLS CUI [1,3]
C1518321
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0332155
documented mild to moderate arterial hypertension: sbp comprised between 140 and 169 mmhg and dbp between 85 and 100 mmhg;
Description

Hypertensive disease Mild | Hypertensive disease Moderate | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
presence of at least one mutated genotype or combination of genotypes corresponding to the list provided in the protocol.
Description

Genotype Mutated Quantity | Genotype Combination

Data type

boolean

Alias
UMLS CUI [1,1]
C0017431
UMLS CUI [1,2]
C1705285
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0017431
UMLS CUI [2,2]
C0205195
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known causes of secondary or severe or malignant hypertension;
Description

Secondary hypertension | Hypertension, severe | Malignant Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C4013784
UMLS CUI [3]
C0020540
significant renal or hepatic disease;
Description

Kidney Disease | Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
cardiac disease requiring prohibited pharmacological treatment or history of myocardial infarction within the last 6 months;
Description

Heart Diseases | Requirement Pharmacotherapy Illicit | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013216
UMLS CUI [2,3]
C0332266
UMLS CUI [3]
C0027051
atrial fibrillation or complete ventricle bundle branch block;
Description

Atrial Fibrillation | Complete bundle branch block

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C3544314
first degree av-block exceeding 240 msec;
Description

First degree atrioventricular block

Data type

boolean

Alias
UMLS CUI [1]
C0085614
electrocardiographic evidence of left ventricular hypertrophy;
Description

ECG left ventricle hypertrophy

Data type

boolean

Alias
UMLS CUI [1]
C0232306
pregnant or nursing women or women of childbearing potential not taking anti-contraceptive medication or not utilizing a double contraceptive method;
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive Agents Absent | Childbearing Potential Contraceptive method Double Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0009871
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0205173
UMLS CUI [4,4]
C0332197
concomitant therapy with medications that may affect blood pressure;
Description

Pharmaceutical Preparations Affecting Blood Pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005823
diabetes mellitus (fasting plasma glucose > 125 mg/dl);
Description

Diabetes Mellitus | Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0583513
statins treatment.
Description

Statin therapy

Data type

boolean

Alias
UMLS CUI [1]
C1278454
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Similar models

Eligibility Essential Hypertension NCT01320397

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Informed Consent Genotype determination
Item
signature of a written informed consent, included informed consent on genotype analysis.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1285573 (UMLS CUI [2,2])
Patient Hypertensive Newly Diagnosed | Patient untreated
Item
naive hypertensive patient (new diagnosed patient, never treated before).
boolean
C0030705 (UMLS CUI [1,1])
C0857121 (UMLS CUI [1,2])
C1518321 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Hypertensive disease Mild | Hypertensive disease Moderate | Systolic Pressure | Diastolic blood pressure
Item
documented mild to moderate arterial hypertension: sbp comprised between 140 and 169 mmhg and dbp between 85 and 100 mmhg;
boolean
C0020538 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Genotype Mutated Quantity | Genotype Combination
Item
presence of at least one mutated genotype or combination of genotypes corresponding to the list provided in the protocol.
boolean
C0017431 (UMLS CUI [1,1])
C1705285 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0017431 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Hypertension, severe | Malignant Hypertension
Item
known causes of secondary or severe or malignant hypertension;
boolean
C0155616 (UMLS CUI [1])
C4013784 (UMLS CUI [2])
C0020540 (UMLS CUI [3])
Kidney Disease | Liver disease
Item
significant renal or hepatic disease;
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Heart Diseases | Requirement Pharmacotherapy Illicit | Myocardial Infarction
Item
cardiac disease requiring prohibited pharmacological treatment or history of myocardial infarction within the last 6 months;
boolean
C0018799 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C0332266 (UMLS CUI [2,3])
C0027051 (UMLS CUI [3])
Atrial Fibrillation | Complete bundle branch block
Item
atrial fibrillation or complete ventricle bundle branch block;
boolean
C0004238 (UMLS CUI [1])
C3544314 (UMLS CUI [2])
First degree atrioventricular block
Item
first degree av-block exceeding 240 msec;
boolean
C0085614 (UMLS CUI [1])
ECG left ventricle hypertrophy
Item
electrocardiographic evidence of left ventricular hypertrophy;
boolean
C0232306 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive Agents Absent | Childbearing Potential Contraceptive method Double Absent
Item
pregnant or nursing women or women of childbearing potential not taking anti-contraceptive medication or not utilizing a double contraceptive method;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0009871 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0205173 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
Pharmaceutical Preparations Affecting Blood Pressure
Item
concomitant therapy with medications that may affect blood pressure;
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
Diabetes Mellitus | Plasma fasting glucose measurement
Item
diabetes mellitus (fasting plasma glucose > 125 mg/dl);
boolean
C0011849 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
Statin therapy
Item
statins treatment.
boolean
C1278454 (UMLS CUI [1])
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