ID

29920

Description

A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00635232

Link

https://clinicaltrials.gov/show/NCT00635232

Keywords

Versions (2)
  1. 4/27/18 4/27/18 -
  2. 4/27/18 4/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 27, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Hypertension NCT00635232

English

Eligibility Hypertension NCT00635232

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females 18 - 70 years
Description

ID.1

Data type

boolean

mean seated systolic blood pressure (sbp) ≥ 140 mmhg and < 180 mmhg and mean seated diastolic blood pressure (dbp) > 90 and < 109 mmhg at two consecutive qualifying visits (visits 3/3.5 and visit 4). the mean difference in dbp between the two consecutive qualifying visits must be ≤ 10 mmhg.
Description

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Measurement Visit Quantity | Difference mean Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C0242485
UMLS CUI [3,2]
C1512346
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C1705242
UMLS CUI [4,2]
C0444504
UMLS CUI [4,3]
C0428883
women of child-bearing potential (wocbp) must use two reliable forms of contraception if sexually active. alternatively, female subjects must be postmenopausal (for at least 1 year).
Description

Childbearing Potential Sexually active Contraceptive methods Quantity | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0232970
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of ps433540, including cardiovascular (includes subjects who are known to have coronary artery disease), renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic, neurologic and psychiatric diseases.
Description

Disease Serious | Other Coding | Investigational New Drugs Evaluation Limited | Cardiovascular Diseases | Coronary Artery Disease | Kidney Diseases | Absence Kidney Quantity | Lung diseases | Liver diseases | Gastrointestinal Diseases | Malabsorption | Endocrine System Diseases | Metabolic Diseases | Hematological Disease | Nervous system disorder | Mental disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1261322
UMLS CUI [3,3]
C0439801
UMLS CUI [4]
C0007222
UMLS CUI [5]
C1956346
UMLS CUI [6]
C0022658
UMLS CUI [7,1]
C0332197
UMLS CUI [7,2]
C0022646
UMLS CUI [7,3]
C1265611
UMLS CUI [8]
C0024115
UMLS CUI [9]
C0023895
UMLS CUI [10]
C0017178
UMLS CUI [11]
C0024523
UMLS CUI [12]
C0014130
UMLS CUI [13]
C0025517
UMLS CUI [14]
C0018939
UMLS CUI [15]
C0027765
UMLS CUI [16]
C0004936
history of malignancy other than adequately treated basal cell or squamous cell skin cancer.
Description

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
subjects with a history of myocardial infarction or new york heart association (nyha) class ii-iv heart failure.
Description

Myocardial Infarction | Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
subjects with a history of cerebrovascular accident or transient ischemic attack.
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular block (av block), left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
Description

Conduction disorder of the heart | Second degree atrioventricular block | Complete atrioventricular block | Left Bundle-Branch Block | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter | Accessory cardiac pathway | Cardiac Arrhythmia Requirement Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0264886
UMLS CUI [2]
C0264906
UMLS CUI [3]
C0151517
UMLS CUI [4]
C0023211
UMLS CUI [5]
C0037052
UMLS CUI [6]
C0004238
UMLS CUI [7]
C0004239
UMLS CUI [8]
C1963785
UMLS CUI [9,1]
C0003811
UMLS CUI [9,2]
C1514873
UMLS CUI [9,3]
C0013227
subjects with hemodynamically significant valvular disease.
Description

Valvular disease Hemodynamic Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
subjects with history of type 1 diabetes mellitus and subjects with a history of type 2 diabetes mellitus using antihyperglycemic medication (oral medication, insulin, or exenatide) are excluded.
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents | Oral medication | Insulin | Exenatide

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0020616
UMLS CUI [4]
C0175795
UMLS CUI [5]
C0021641
UMLS CUI [6]
C0167117
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Similar models

Eligibility Hypertension NCT00635232

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
males or females 18 - 70 years
boolean
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Measurement Visit Quantity | Difference mean Diastolic blood pressure
Item
mean seated systolic blood pressure (sbp) ≥ 140 mmhg and < 180 mmhg and mean seated diastolic blood pressure (dbp) > 90 and < 109 mmhg at two consecutive qualifying visits (visits 3/3.5 and visit 4). the mean difference in dbp between the two consecutive qualifying visits must be ≤ 10 mmhg.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0242485 (UMLS CUI [3,1])
C1512346 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C1705242 (UMLS CUI [4,1])
C0444504 (UMLS CUI [4,2])
C0428883 (UMLS CUI [4,3])
Childbearing Potential Sexually active Contraceptive methods Quantity | Postmenopausal state
Item
women of child-bearing potential (wocbp) must use two reliable forms of contraception if sexually active. alternatively, female subjects must be postmenopausal (for at least 1 year).
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0232970 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Disease Serious | Other Coding | Investigational New Drugs Evaluation Limited | Cardiovascular Diseases | Coronary Artery Disease | Kidney Diseases | Absence Kidney Quantity | Lung diseases | Liver diseases | Gastrointestinal Diseases | Malabsorption | Endocrine System Diseases | Metabolic Diseases | Hematological Disease | Nervous system disorder | Mental disorders
Item
subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of ps433540, including cardiovascular (includes subjects who are known to have coronary artery disease), renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic, neurologic and psychiatric diseases.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0007222 (UMLS CUI [4])
C1956346 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0332197 (UMLS CUI [7,1])
C0022646 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
C0024115 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
C0017178 (UMLS CUI [10])
C0024523 (UMLS CUI [11])
C0014130 (UMLS CUI [12])
C0025517 (UMLS CUI [13])
C0018939 (UMLS CUI [14])
C0027765 (UMLS CUI [15])
C0004936 (UMLS CUI [16])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
history of malignancy other than adequately treated basal cell or squamous cell skin cancer.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Myocardial Infarction | Heart failure New York Heart Association Classification
Item
subjects with a history of myocardial infarction or new york heart association (nyha) class ii-iv heart failure.
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
subjects with a history of cerebrovascular accident or transient ischemic attack.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Conduction disorder of the heart | Second degree atrioventricular block | Complete atrioventricular block | Left Bundle-Branch Block | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter | Accessory cardiac pathway | Cardiac Arrhythmia Requirement Pharmaceutical Preparations
Item
subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular block (av block), left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
boolean
C0264886 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0023211 (UMLS CUI [4])
C0037052 (UMLS CUI [5])
C0004238 (UMLS CUI [6])
C0004239 (UMLS CUI [7])
C1963785 (UMLS CUI [8])
C0003811 (UMLS CUI [9,1])
C1514873 (UMLS CUI [9,2])
C0013227 (UMLS CUI [9,3])
Valvular disease Hemodynamic Significant
Item
subjects with hemodynamically significant valvular disease.
boolean
C3258293 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents | Oral medication | Insulin | Exenatide
Item
subjects with history of type 1 diabetes mellitus and subjects with a history of type 2 diabetes mellitus using antihyperglycemic medication (oral medication, insulin, or exenatide) are excluded.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0020616 (UMLS CUI [3])
C0175795 (UMLS CUI [4])
C0021641 (UMLS CUI [5])
C0167117 (UMLS CUI [6])
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