ID

29915

Description

Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine; ODM derived from: https://clinicaltrials.gov/show/NCT00626743

Link

https://clinicaltrials.gov/show/NCT00626743

Keywords

Versions (1)
  1. 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 4.0
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Eligibility Hypertension NCT00626743

English

Eligibility Hypertension NCT00626743

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male subjects 19-65 years of age inclusive
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
subjects with hypertension as defined 100 mmhg ≤ sbp<140 mmhg and 65 mmhg ≤ dbp < 90 mmhg after more than 5 minutes in the supine position
Description

Hypertensive disease | Lying systolic blood pressure | Lying diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C1319895
UMLS CUI [3]
C1319896
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willing and able to comply with the requirements of the protocol
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with acute or chronic disease within 4 weeks of study initiation.
Description

Acute Disease | Chronic disease

Data type

boolean

Alias
UMLS CUI [1]
C0001314
UMLS CUI [2]
C0008679
subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.)
Description

Gastrointestinal Diseases Changing Drug absorption | Exception Appendectomy | Exception Herniotomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003611
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0405600
subjects with any clinically significant allergic disease or with a known allergy to the pde5 inhibitors
Description

Hypersensitivity | Hypersensitivity Phosphodiesterase 5 inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1318700
subjects with clinically significant abnormalities on laboratory tests
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmhg or diastolic blood pressure of at least 10 mmhg when a person assumes a standing position
Description

Hypotension, Orthostatic | Standing systolic blood pressure Decreased | Standing diastolic blood pressure Decreased

Data type

boolean

Alias
UMLS CUI [1]
C0020651
UMLS CUI [2,1]
C1303018
UMLS CUI [2,2]
C0205216
UMLS CUI [3,1]
C1303019
UMLS CUI [3,2]
C0205216
subjects with abnormal qtc interval(≥440ms)
Description

QTc interval Abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0205161
subjects with color-blindness or weakness
Description

Color blindness | Weakness

Data type

boolean

Alias
UMLS CUI [1]
C0242225
UMLS CUI [2]
C3714552
subejcts with alcohol, drug or caffeine abuse
Description

Substance Use Disorders | Caffeine abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0679260
diet known to alter drug absorption, distribution, metabolism or elimination processes
Description

Diet Changing Drug absorption | Diet Changing Drug distribution | Diet Changing Drug metabolism | Diet Changing Drug elimination

Data type

boolean

Alias
UMLS CUI [1,1]
C0012155
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012155
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0870449
UMLS CUI [3,1]
C0012155
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0012155
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C0683141
subjects who participated in other clinical studies within 2 months before an administration
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
other subjects who are ineligible for the study at the discretion of the principle investigator or sub-investigators
Description

Study Subject Participation Status Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
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Similar models

Eligibility Hypertension NCT00626743

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
male subjects 19-65 years of age inclusive
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hypertensive disease | Lying systolic blood pressure | Lying diastolic blood pressure
Item
subjects with hypertension as defined 100 mmhg ≤ sbp<140 mmhg and 65 mmhg ≤ dbp < 90 mmhg after more than 5 minutes in the supine position
boolean
C0020538 (UMLS CUI [1])
C1319895 (UMLS CUI [2])
C1319896 (UMLS CUI [3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with the requirements of the protocol
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Disease | Chronic disease
Item
subjects with acute or chronic disease within 4 weeks of study initiation.
boolean
C0001314 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Gastrointestinal Diseases Changing Drug absorption | Exception Appendectomy | Exception Herniotomy
Item
subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.)
boolean
C0017178 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0003611 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0405600 (UMLS CUI [3,2])
Hypersensitivity | Hypersensitivity Phosphodiesterase 5 inhibitor
Item
subjects with any clinically significant allergic disease or with a known allergy to the pde5 inhibitors
boolean
C0020517 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1318700 (UMLS CUI [2,2])
Laboratory test result abnormal
Item
subjects with clinically significant abnormalities on laboratory tests
boolean
C0438215 (UMLS CUI [1])
Hypotension, Orthostatic | Standing systolic blood pressure Decreased | Standing diastolic blood pressure Decreased
Item
subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmhg or diastolic blood pressure of at least 10 mmhg when a person assumes a standing position
boolean
C0020651 (UMLS CUI [1])
C1303018 (UMLS CUI [2,1])
C0205216 (UMLS CUI [2,2])
C1303019 (UMLS CUI [3,1])
C0205216 (UMLS CUI [3,2])
QTc interval Abnormal
Item
subjects with abnormal qtc interval(≥440ms)
boolean
C0489625 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Color blindness | Weakness
Item
subjects with color-blindness or weakness
boolean
C0242225 (UMLS CUI [1])
C3714552 (UMLS CUI [2])
Substance Use Disorders | Caffeine abuse
Item
subejcts with alcohol, drug or caffeine abuse
boolean
C0038586 (UMLS CUI [1])
C0679260 (UMLS CUI [2])
Diet Changing Drug absorption | Diet Changing Drug distribution | Diet Changing Drug metabolism | Diet Changing Drug elimination
Item
diet known to alter drug absorption, distribution, metabolism or elimination processes
boolean
C0012155 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0012155 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0870449 (UMLS CUI [2,3])
C0012155 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0012155 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
Study Subject Participation Status
Item
subjects who participated in other clinical studies within 2 months before an administration
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Ineligible
Item
other subjects who are ineligible for the study at the discretion of the principle investigator or sub-investigators
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
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