ID

17693

Beskrivning

A Clinical Study to Evaluate the Effects of Darusentan on Safety and Efficacy in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Blood Pressure Lowering Drugs; ODM derived from: https://clinicaltrials.gov/show/NCT00364026

Länk

https://clinicaltrials.gov/show/NCT00364026

Nyckelord

  1. 2016-09-28 2016-09-28 -
Uppladdad den

28 september 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Hypertension NCT00364026

Eligibility Hypertension NCT00364026

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who are competent to provide written consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
aged 35 to 85 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmhg
Beskrivning

Diabetes Mellitus | Chronic Kidney Disease | Systolic Pressure mean

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C1561643
UMLS CUI [3,1]
C0871470
UMLS CUI [3,2]
C0444504
all other subjects must have a mean systolic blood pressure ≥140 mmhg
Beskrivning

Systolic Pressure mean

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0444504
receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
Beskrivning

Antihypertensive Agents Dose Full | Antihypertensive Agents Class Quantity | Diuretics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443225
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1547013
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0012798
female subjects of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the time of randomization.
Beskrivning

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
average sitting systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg at screening
Beskrivning

Sitting systolic blood pressure Average | Sitting diastolic blood pressure Average

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C1510992
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C1510992
serum alt or ast >2x uln
Beskrivning

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
subjects who have experienced myocardial infarction, unstable angina, or a cerebrovascular accident (cva) within 6 month of the screening visit; or sick sinus syndrome or second or third degree atrioventricular block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
Beskrivning

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block | Chronic atrial fibrillation | Tachyarrhythmia Atrial Recurrent | Recurrent ventricular tachycardia | BRADYCARDIA SYMPTOMATIC

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0037052
UMLS CUI [5]
C0264906
UMLS CUI [6]
C0151517
UMLS CUI [7]
C0694539
UMLS CUI [8,1]
C0080203
UMLS CUI [8,2]
C0018792
UMLS CUI [8,3]
C2945760
UMLS CUI [9]
C1737264
UMLS CUI [10]
C0741627
implanted cardioverter defibrillator (icd) that has fired for any arrhythmia within 3 months of screening or implanted pacemakers
Beskrivning

Implantable defibrillator | Cardiac Arrhythmia | pacemaker implant

Datatyp

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0848753
symptomatic chf requiring treatment
Beskrivning

Symptomatic congestive heart failure Requirement Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0742758
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
hemodynamically significant valvular heart disease
Beskrivning

Heart valve disease Hemodynamic Significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
hemodialysis or peritoneal dialysis; or history of renal transplant
Beskrivning

Hemodialysis | Peritoneal Dialysis | Kidney Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2]
C0031139
UMLS CUI [3]
C0022671
diagnosis or recurrence of malignancy within the past 3 years
Beskrivning

Malignant Neoplasms | Recurrent Malignant Neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1458156
sleep apnea
Beskrivning

Sleep Apnea

Datatyp

boolean

Alias
UMLS CUI [1]
C0037315
subjects who perform alternating shift or night work
Beskrivning

shift work | night work

Datatyp

boolean

Alias
UMLS CUI [1]
C1658633
UMLS CUI [2]
C1659095
subjects who have participated in a clinical study involving another investigational drug or device within 1 month of the screening visit
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570

Similar models

Eligibility Hypertension NCT00364026

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subjects who are competent to provide written consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
aged 35 to 85 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus | Chronic Kidney Disease | Systolic Pressure mean
Item
subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmhg
boolean
C0011849 (UMLS CUI [1])
C1561643 (UMLS CUI [2])
C0871470 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Systolic Pressure mean
Item
all other subjects must have a mean systolic blood pressure ≥140 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Antihypertensive Agents Dose Full | Antihypertensive Agents Class Quantity | Diuretics
Item
receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
boolean
C0003364 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443225 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2,1])
C1547013 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0012798 (UMLS CUI [3])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
female subjects of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the time of randomization.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Sitting systolic blood pressure Average | Sitting diastolic blood pressure Average
Item
average sitting systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg at screening
boolean
C1319893 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C1510992 (UMLS CUI [2,2])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
serum alt or ast >2x uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block | Chronic atrial fibrillation | Tachyarrhythmia Atrial Recurrent | Recurrent ventricular tachycardia | BRADYCARDIA SYMPTOMATIC
Item
subjects who have experienced myocardial infarction, unstable angina, or a cerebrovascular accident (cva) within 6 month of the screening visit; or sick sinus syndrome or second or third degree atrioventricular block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0037052 (UMLS CUI [4])
C0264906 (UMLS CUI [5])
C0151517 (UMLS CUI [6])
C0694539 (UMLS CUI [7])
C0080203 (UMLS CUI [8,1])
C0018792 (UMLS CUI [8,2])
C2945760 (UMLS CUI [8,3])
C1737264 (UMLS CUI [9])
C0741627 (UMLS CUI [10])
Implantable defibrillator | Cardiac Arrhythmia | pacemaker implant
Item
implanted cardioverter defibrillator (icd) that has fired for any arrhythmia within 3 months of screening or implanted pacemakers
boolean
C0162589 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0848753 (UMLS CUI [3])
Symptomatic congestive heart failure Requirement Therapeutic procedure
Item
symptomatic chf requiring treatment
boolean
C0742758 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Heart valve disease Hemodynamic Significant
Item
hemodynamically significant valvular heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Hemodialysis | Peritoneal Dialysis | Kidney Transplantation
Item
hemodialysis or peritoneal dialysis; or history of renal transplant
boolean
C0019004 (UMLS CUI [1])
C0031139 (UMLS CUI [2])
C0022671 (UMLS CUI [3])
Malignant Neoplasms | Recurrent Malignant Neoplasm
Item
diagnosis or recurrence of malignancy within the past 3 years
boolean
C0006826 (UMLS CUI [1])
C1458156 (UMLS CUI [2])
Sleep Apnea
Item
sleep apnea
boolean
C0037315 (UMLS CUI [1])
shift work | night work
Item
subjects who perform alternating shift or night work
boolean
C1658633 (UMLS CUI [1])
C1659095 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
subjects who have participated in a clinical study involving another investigational drug or device within 1 month of the screening visit
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])

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