ID

17693

Description

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

Link

https://clinicaltrials.gov/show/NCT00364026

Keywords

Versions (1)
  1. 9/28/16 9/28/16 -
Uploaded on

September 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00364026

English

Eligibility Hypertension NCT00364026

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Informed Consent

Data type

boolean

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

Age

Data type

boolean

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

Diabetes Mellitus | Chronic Kidney Disease | Systolic Pressure mean

Data type

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
Description

Systolic Pressure mean

Data type

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
Description

Antihypertensive Agents Dose Full | Antihypertensive Agents Class Quantity | Diuretics

Data type

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.
Description

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

Data type

boolean

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

Exclusion Criteria

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

Sitting systolic blood pressure Average | Sitting diastolic blood pressure Average

Data type

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
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

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
Description

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

Data type

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
Description

Implantable defibrillator | Cardiac Arrhythmia | pacemaker implant

Data type

boolean

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

Symptomatic congestive heart failure Requirement Therapeutic procedure

Data type

boolean

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

Heart valve disease Hemodynamic Significant

Data type

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
Description

Hemodialysis | Peritoneal Dialysis | Kidney Transplantation

Data type

boolean

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

Malignant Neoplasms | Recurrent Malignant Neoplasm

Data type

boolean

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

Sleep Apnea

Data type

boolean

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

shift work | night work

Data type

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
Description

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

Data type

boolean

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

Eligibility Hypertension NCT00364026

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