ID

23187

Description

A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00522925

Link

https://clinicaltrials.gov/show/NCT00522925

Keywords

  1. 6/27/17 6/27/17 -
Uploaded on

June 27, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Hypertension NCT00522925

Eligibility Hypertension NCT00522925

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females 30 - 80 years
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C0001779
mean seated systolic blood pressure (sbp) ≥ 150 - ≤ 179 mmhg and mean seated dbp < 110 mmhg at two consecutive qualifying visits. the mean difference in sbp between the two consecutive qualifying visits must be ≤ 10 mmhg.
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C0005823
mean daytime (8am - 4pm) ambulatory sbp must be between ≥ 140 - ≤ 179 mmhg and mean daytime (8am - 4pm) diastolic blood pressure (dbp) ≤ 110 mmhg
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0005823
subjects must have a usual daytime schedule. night shift workers are excluded from participation.
Description

ID.4

Data type

boolean

women of child-bearing potential (wocbp) and male subjects must use two reliable forms of contraception if sexually active. alternatively, female subjects must be postmenopausal (for at least 1 year)
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1,1]
C0009862
UMLS CUI [1,2]
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, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C0012634
subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or new york heart association (nyha) class ii-iv heart failure within the last 6 months.
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C0018799
subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0007787
subjects with diabetes mellitus (type i and type ii).
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C0011849

Similar models

Eligibility Hypertension NCT00522925

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
males or females 30 - 80 years
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
mean seated systolic blood pressure (sbp) ≥ 150 - ≤ 179 mmhg and mean seated dbp < 110 mmhg at two consecutive qualifying visits. the mean difference in sbp between the two consecutive qualifying visits must be ≤ 10 mmhg.
boolean
C0005823 (UMLS CUI [1])
ID.3
Item
mean daytime (8am - 4pm) ambulatory sbp must be between ≥ 140 - ≤ 179 mmhg and mean daytime (8am - 4pm) diastolic blood pressure (dbp) ≤ 110 mmhg
boolean
C0005823 (UMLS CUI [1])
ID.4
Item
subjects must have a usual daytime schedule. night shift workers are excluded from participation.
boolean
ID.5
Item
women of child-bearing potential (wocbp) and male subjects must use two reliable forms of contraception if sexually active. alternatively, female subjects must be postmenopausal (for at least 1 year)
boolean
C0009862 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of ps433540, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
boolean
C0012634 (UMLS CUI [1])
ID.7
Item
subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or new york heart association (nyha) class ii-iv heart failure within the last 6 months.
boolean
C0018799 (UMLS CUI [1])
ID.8
Item
subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
boolean
C0038454 (UMLS CUI [1,1])
C0007787 (UMLS CUI [1,2])
ID.9
Item
subjects with diabetes mellitus (type i and type ii).
boolean
C0011849 (UMLS CUI [1])

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