ID

36123

Description

An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02235909

Link

https://clinicaltrials.gov/show/NCT02235909

Keywords

Versions (1)
  1. 4/16/19 4/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT02235909

English

Eligibility Hypertension NCT02235909

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the subject has hypertension (primary or secondary) defined as clinic seated diastolic bp ≥95th percentile (by age, gender, and height) or ≥90th percentile (by age, gender, height) if chronic renal disease, diabetes, heart failure or hypertensive target organ damage is present
Description

Essential Hypertension | Secondary hypertension | Sitting diastolic blood pressure | Age | Gender | Body Height | Chronic Kidney Diseases | Diabetes Mellitus | Heart failure | Target Organ Damage Hypertensive

Data type

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2]
C0155616
UMLS CUI [3]
C1319894
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0079399
UMLS CUI [6]
C0005890
UMLS CUI [7]
C1561643
UMLS CUI [8]
C0011849
UMLS CUI [9]
C0018801
UMLS CUI [10,1]
C1521840
UMLS CUI [10,2]
C0178784
UMLS CUI [10,3]
C1883709
UMLS CUI [10,4]
C0857121
1. if currently treated: the subject has a documented historical diagnosis of hypertension and a post-washout clinic seated diastolic bp meeting the above criteria on day -1 (or day 1 for subjects not participating in ambulatory blood pressure monitoring)
Description

Patients Treated | Hypertensive disease | Status post Washout Period | Sitting diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522326
UMLS CUI [2]
C0020538
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1710661
UMLS CUI [4]
C1319894
2. if currently untreated: the subject has elevated seated diastolic bp meeting the above criteria on 3 separate occasions before randomization, including on day -1 (or day 1 for subjects not participating in ambulatory blood pressure monitoring)
Description

Patients Untreated | Sitting diastolic blood pressure Elevated | Measurement Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C3163633
UMLS CUI [3,1]
C0242485
UMLS CUI [3,2]
C1265611
the subject is male or female and aged 6 to <18 years at baseline and weighs at least 25 kg
Description

Age | Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
the subject agrees to continue their previously implemented nonpharmacological life style modifications if begun prior to screening. note: for subjects participating in a weight loss program, the weight maintenance
Description

Life Style Modification Continue | Pharmacotherapy Absent | Participation Weight Reduction Programs | Body Weight Maintenance

Data type

boolean

Alias
UMLS CUI [1,1]
C0023676
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0549178
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C3179079
UMLS CUI [4]
C4042910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has a clinic seated diastolic bp greater than 15 mm hg and/or seated diastolic bp greater than 10 mm hg above the 99th percentile for age, gender, and height as confirmed by the average (arithmetic mean) of 3 serial clinic seated bp measurements at screening/visit 1
Description

Sitting diastolic blood pressure | Age | Gender | Body Height | Average Measurement Quantity

Data type

boolean

Alias
UMLS CUI [1]
C1319894
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0005890
UMLS CUI [5,1]
C1510992
UMLS CUI [5,2]
C0242485
UMLS CUI [5,3]
C1265611
the subject has a diagnosis of malignant or accelerated hypertension
Description

Accelerated Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020540
the subject is currently treated with more than 2 antihypertensive agents
Description

Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
the subject or parent/legal guardian is not willing for the subject's previous antihypertensive medications to be stopped
Description

Antihypertensive Agents To be stopped Unwilling | Antihypertensive Agents To be stopped Parent Unwilling | Antihypertensive Agents To be stopped Legal Guardian Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1272691
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1272691
UMLS CUI [2,3]
C0030551
UMLS CUI [2,4]
C0558080
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1272691
UMLS CUI [3,3]
C0023226
UMLS CUI [3,4]
C0558080
the subject has participated in the intensive, active weight-loss phase of a weight-loss program within 30 days prior to screening/visit 1
Description

Participation Weight Reduction Program With intensity

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3179079
UMLS CUI [1,3]
C0522510
the subject has any of the following: severe renal impairment (egfr <30 ml/min/1.73 m2 by the schwartz formula); is currently undergoing dialysis treatment; renovascular disease affecting both kidneys or a solitary kidney; severe nephrotic syndrome not in remission; or serum albumin <2.5 g/dl
Description

Renal Insufficiency Severe | Estimated Glomerular Filtration Rate Creatinine-based formula (Schwartz) | Dialysis | Renal vascular disorder Affecting Both kidneys | Renal vascular disorder Affecting Kidney Solitary | Nephrotic Syndrome Severe | Remission Lacking | Serum albumin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3811844
UMLS CUI [2,2]
C1980037
UMLS CUI [3]
C0011946
UMLS CUI [4,1]
C0268790
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0227665
UMLS CUI [5,1]
C0268790
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0022646
UMLS CUI [5,4]
C0205171
UMLS CUI [6,1]
C0027726
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0544452
UMLS CUI [7,2]
C0332268
UMLS CUI [8]
C0523465
the subject has a history or clinical manifestations of severe cardiovascular, hepato-biliary, gastrointestinal, endocrine-metabolic (e.g., hyperthyroidism, cushing's syndrome), hematologic, immunologic, genito-urinary, or psychiatric disease, cancer, and/or any conditions that would interfere with the health status of the subject through study participation, or would jeopardize study integrity in the opinion of the investigator
Description

Cardiovascular Diseases Severe | Hepatobiliary disease Severe | Gastrointestinal Diseases Severe | Endocrine System Diseases Severe | Metabolic Diseases Severe | Hyperthyroidism | Cushing Syndrome | Hematological Disease Severe | Immune System Diseases Severe | Disorder of the genitourinary system Severe | Mental Disorders, Severe | Malignant Neoplasms | Condition Interferes with Study Subject Participation Status | Condition compromises Clinical Trial Integrity

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0267792
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0014130
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0025517
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0020550
UMLS CUI [7]
C0010481
UMLS CUI [8,1]
C0018939
UMLS CUI [8,2]
C0205082
UMLS CUI [9,1]
C0021053
UMLS CUI [9,2]
C0205082
UMLS CUI [10,1]
C0080276
UMLS CUI [10,2]
C0205082
UMLS CUI [11]
C4046029
UMLS CUI [12]
C0006826
UMLS CUI [13,1]
C0348080
UMLS CUI [13,2]
C0521102
UMLS CUI [13,3]
C2348568
UMLS CUI [14,1]
C0348080
UMLS CUI [14,2]
C2945640
UMLS CUI [14,3]
C0008976
UMLS CUI [14,4]
C1947912
the subject is suffering from uncorrected coarctation of the aorta, or hemodynamically significant left ventricular outflow tract obstruction due to eg, aortic valvular disease, or is likely to undergo a procedure known to affect blood pressure (eg, repair of arterial anomalies) during the course of the study
Description

Aortic coarctation uncorrected | Left ventricular outflow tract obstruction Due to Eosinophilic gastroenteritis | Aortic valve disorder | Procedure Affecting Blood Pressure | Repair Arterial malformation

Data type

boolean

Alias
UMLS CUI [1,1]
C0003492
UMLS CUI [1,2]
C4072785
UMLS CUI [2,1]
C0344917
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1262481
UMLS CUI [3]
C1260873
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0005823
UMLS CUI [5,1]
C4319951
UMLS CUI [5,2]
C0151489
the subject is poorly controlled diabetic defined as having a glycosylated hemoglobin value >8.5% at screening/visit 1
Description

Poorly controlled diabetes mellitus | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C0474680
the subject has hyperkalemia as defined by the central laboratory's normal reference range or any pertinent electrolyte disorders at screening/visit
Description

Hyperkalemia | Disorder of electrolytes

Data type

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2]
C1704431
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Similar models

Eligibility Hypertension NCT02235909

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension | Secondary hypertension | Sitting diastolic blood pressure | Age | Gender | Body Height | Chronic Kidney Diseases | Diabetes Mellitus | Heart failure | Target Organ Damage Hypertensive
Item
the subject has hypertension (primary or secondary) defined as clinic seated diastolic bp ≥95th percentile (by age, gender, and height) or ≥90th percentile (by age, gender, height) if chronic renal disease, diabetes, heart failure or hypertensive target organ damage is present
boolean
C0085580 (UMLS CUI [1])
C0155616 (UMLS CUI [2])
C1319894 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
C0005890 (UMLS CUI [6])
C1561643 (UMLS CUI [7])
C0011849 (UMLS CUI [8])
C0018801 (UMLS CUI [9])
C1521840 (UMLS CUI [10,1])
C0178784 (UMLS CUI [10,2])
C1883709 (UMLS CUI [10,3])
C0857121 (UMLS CUI [10,4])
Patients Treated | Hypertensive disease | Status post Washout Period | Sitting diastolic blood pressure
Item
1. if currently treated: the subject has a documented historical diagnosis of hypertension and a post-washout clinic seated diastolic bp meeting the above criteria on day -1 (or day 1 for subjects not participating in ambulatory blood pressure monitoring)
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1710661 (UMLS CUI [3,2])
C1319894 (UMLS CUI [4])
Patients Untreated | Sitting diastolic blood pressure Elevated | Measurement Quantity
Item
2. if currently untreated: the subject has elevated seated diastolic bp meeting the above criteria on 3 separate occasions before randomization, including on day -1 (or day 1 for subjects not participating in ambulatory blood pressure monitoring)
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C3163633 (UMLS CUI [2,2])
C0242485 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Age | Body Weight
Item
the subject is male or female and aged 6 to <18 years at baseline and weighs at least 25 kg
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Life Style Modification Continue | Pharmacotherapy Absent | Participation Weight Reduction Programs | Body Weight Maintenance
Item
the subject agrees to continue their previously implemented nonpharmacological life style modifications if begun prior to screening. note: for subjects participating in a weight loss program, the weight maintenance
boolean
C0023676 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0013216 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0679823 (UMLS CUI [3,1])
C3179079 (UMLS CUI [3,2])
C4042910 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Sitting diastolic blood pressure | Age | Gender | Body Height | Average Measurement Quantity
Item
the subject has a clinic seated diastolic bp greater than 15 mm hg and/or seated diastolic bp greater than 10 mm hg above the 99th percentile for age, gender, and height as confirmed by the average (arithmetic mean) of 3 serial clinic seated bp measurements at screening/visit 1
boolean
C1319894 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0005890 (UMLS CUI [4])
C1510992 (UMLS CUI [5,1])
C0242485 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Accelerated Hypertension
Item
the subject has a diagnosis of malignant or accelerated hypertension
boolean
C0020540 (UMLS CUI [1])
Antihypertensive Agents Quantity
Item
the subject is currently treated with more than 2 antihypertensive agents
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Antihypertensive Agents To be stopped Unwilling | Antihypertensive Agents To be stopped Parent Unwilling | Antihypertensive Agents To be stopped Legal Guardian Unwilling
Item
the subject or parent/legal guardian is not willing for the subject's previous antihypertensive medications to be stopped
boolean
C0003364 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0030551 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
C0003364 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C0023226 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
Participation Weight Reduction Program With intensity
Item
the subject has participated in the intensive, active weight-loss phase of a weight-loss program within 30 days prior to screening/visit 1
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate Creatinine-based formula (Schwartz) | Dialysis | Renal vascular disorder Affecting Both kidneys | Renal vascular disorder Affecting Kidney Solitary | Nephrotic Syndrome Severe | Remission Lacking | Serum albumin measurement
Item
the subject has any of the following: severe renal impairment (egfr <30 ml/min/1.73 m2 by the schwartz formula); is currently undergoing dialysis treatment; renovascular disease affecting both kidneys or a solitary kidney; severe nephrotic syndrome not in remission; or serum albumin <2.5 g/dl
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2,1])
C1980037 (UMLS CUI [2,2])
C0011946 (UMLS CUI [3])
C0268790 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0227665 (UMLS CUI [4,3])
C0268790 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0022646 (UMLS CUI [5,3])
C0205171 (UMLS CUI [5,4])
C0027726 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0544452 (UMLS CUI [7,1])
C0332268 (UMLS CUI [7,2])
C0523465 (UMLS CUI [8])
Cardiovascular Diseases Severe | Hepatobiliary disease Severe | Gastrointestinal Diseases Severe | Endocrine System Diseases Severe | Metabolic Diseases Severe | Hyperthyroidism | Cushing Syndrome | Hematological Disease Severe | Immune System Diseases Severe | Disorder of the genitourinary system Severe | Mental Disorders, Severe | Malignant Neoplasms | Condition Interferes with Study Subject Participation Status | Condition compromises Clinical Trial Integrity
Item
the subject has a history or clinical manifestations of severe cardiovascular, hepato-biliary, gastrointestinal, endocrine-metabolic (e.g., hyperthyroidism, cushing's syndrome), hematologic, immunologic, genito-urinary, or psychiatric disease, cancer, and/or any conditions that would interfere with the health status of the subject through study participation, or would jeopardize study integrity in the opinion of the investigator
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0267792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0017178 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0014130 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0025517 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0020550 (UMLS CUI [6])
C0010481 (UMLS CUI [7])
C0018939 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0021053 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0080276 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C4046029 (UMLS CUI [11])
C0006826 (UMLS CUI [12])
C0348080 (UMLS CUI [13,1])
C0521102 (UMLS CUI [13,2])
C2348568 (UMLS CUI [13,3])
C0348080 (UMLS CUI [14,1])
C2945640 (UMLS CUI [14,2])
C0008976 (UMLS CUI [14,3])
C1947912 (UMLS CUI [14,4])
Aortic coarctation uncorrected | Left ventricular outflow tract obstruction Due to Eosinophilic gastroenteritis | Aortic valve disorder | Procedure Affecting Blood Pressure | Repair Arterial malformation
Item
the subject is suffering from uncorrected coarctation of the aorta, or hemodynamically significant left ventricular outflow tract obstruction due to eg, aortic valvular disease, or is likely to undergo a procedure known to affect blood pressure (eg, repair of arterial anomalies) during the course of the study
boolean
C0003492 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C0344917 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1262481 (UMLS CUI [2,3])
C1260873 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0005823 (UMLS CUI [4,3])
C4319951 (UMLS CUI [5,1])
C0151489 (UMLS CUI [5,2])
Poorly controlled diabetes mellitus | Hemoglobin A1c measurement
Item
the subject is poorly controlled diabetic defined as having a glycosylated hemoglobin value >8.5% at screening/visit 1
boolean
C0554876 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Hyperkalemia | Disorder of electrolytes
Item
the subject has hyperkalemia as defined by the central laboratory's normal reference range or any pertinent electrolyte disorders at screening/visit
boolean
C0020461 (UMLS CUI [1])
C1704431 (UMLS CUI [2])
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