ID

24447

Beschrijving

Antihypertensive Efficacy and Tolerability and Determine the Adequate Antihypertensive Dosage of Fimasartan in Mild to Moderate Essential Hypertension Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00923611

Link

https://clinicaltrials.gov/show/NCT00923611

Trefwoorden

Versies (1)
  1. 01-08-17 01-08-17 -
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1 augustus 2017

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension NCT00923611

Engels

Eligibility Hypertension NCT00923611

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
mild to moderate essential hypertension : sitting diastolic blood pressure measured at screening and baseline(day1) are 95~114 mmhg inclusive and the difference between sitting diastolic blood pressures measured at day -14 and baseline(day1) is under 7mmhg.
Beschrijving

Essential Hypertension Mild | Essential Hypertension Moderate | Sitting diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C1319894
subjects who agree to participate in this sudy and give written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
Beschrijving

Comprehension Study Protocol | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
the sitting dbp is less than 94mmhg or more than 115mmhg or severe hypertensive patient with sitting systolic blood pressure over 200mmhg
Beschrijving

Sitting diastolic blood pressure | Hypertension, severe

Datatype

boolean

Alias
UMLS CUI [1]
C1319894
UMLS CUI [2]
C4013784
patients with secondary hypertension
Beschrijving

Secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
patients with severe renal(creatinine more 1.5 times than upper limit of normal), gastrointestinal, hematological or hepatic(ast, alt more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug
Beschrijving

Kidney Disease Severe | Serum creatinine raised | Gastrointestinal Disease Severe | Hematological Disease Severe | Liver disease Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased | Investigational New Drug Absorption Affected | Investigational New Drug Disposition Affected | Investigational New Drug Metabolism Affected | Investigational New Drug Excretion Affected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0700225
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0151904
UMLS CUI [7]
C0151905
UMLS CUI [8,1]
C0013230
UMLS CUI [8,2]
C0678745
UMLS CUI [8,3]
C0392760
UMLS CUI [9,1]
C0013230
UMLS CUI [9,2]
C0678755
UMLS CUI [9,3]
C0392760
UMLS CUI [10,1]
C0013230
UMLS CUI [10,2]
C0025520
UMLS CUI [10,3]
C0392760
UMLS CUI [11,1]
C0013230
UMLS CUI [11,2]
C0683141
UMLS CUI [11,3]
C0392760
patients with postural hypotension
Beschrijving

Hypotension, Orthostatic

Datatype

boolean

Alias
UMLS CUI [1]
C0020651
patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(hba1c>9%, regimen change of oral hypoglycemic agents within 3 months, treated insulin before screening)
Beschrijving

Insulin-Dependent Diabetes Mellitus Severe | Diabetic - poor control | Glycosylated hemoglobin A | Oral hypoglycemic | Therapy regimen changed | Insulin regime

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0421258
UMLS CUI [3]
C0019018
UMLS CUI [4]
C0359086
UMLS CUI [5]
C1141862
UMLS CUI [6]
C0557978
patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
Beschrijving

Myocardial Infarction | Coronary Artery Disease Severe | Heart failure | Valvular defects

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0018801
UMLS CUI [4]
C2748945
patients with consumptive disease, autoimmune disease, connective tissue disease
Beschrijving

Cachexia | Autoimmune Diseases | Connective Tissue Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0006625
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0009782
patients with a history of type b or c hepatitis
Beschrijving

Hepatitis B | Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
patients with hiv or hepatitis
Beschrijving

HIV Infection | Hepatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019158
patients with clinically significant laboratory abnormality
Beschrijving

Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0438215
patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure
Beschrijving

Pharmaceutical Preparations Affecting Blood Pressure | Therapeutic procedure Affecting Blood Pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005823
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0005823
patients with allergy or contraindication to any angiotensin ii receptor antagonists
Beschrijving

Allergy to angiotensin II receptor antagonist | Medical contraindication Angiotensin II receptor antagonist

Datatype

boolean

Alias
UMLS CUI [1]
C2585204
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0521942
female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
Beschrijving

Childbearing Potential Hysterectomy Lacking | Childbearing Potential Postmenopausal state Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0020699
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0232970
UMLS CUI [2,3]
C0332197
patients judged to have a history of alcohol or drug abuse by the investigator
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
patients with average weight > +35% or <-15% in modified metropolitan life insurance table
Beschrijving

Body Weight Average

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1510992
patients participated other clinical trial 3 months before screening
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
patients judged to be inappropriate for this study by the investigator with other reasons
Beschrijving

Study Subject Participation Status Inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Hypertension NCT00923611

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension Mild | Essential Hypertension Moderate | Sitting diastolic blood pressure
Item
mild to moderate essential hypertension : sitting diastolic blood pressure measured at screening and baseline(day1) are 95~114 mmhg inclusive and the difference between sitting diastolic blood pressures measured at day -14 and baseline(day1) is under 7mmhg.
boolean
C0085580 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0085580 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3])
Informed Consent
Item
subjects who agree to participate in this sudy and give written informed consent
boolean
C0021430 (UMLS CUI [1])
Comprehension Study Protocol | Protocol Compliance
Item
subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Sitting diastolic blood pressure | Hypertension, severe
Item
the sitting dbp is less than 94mmhg or more than 115mmhg or severe hypertensive patient with sitting systolic blood pressure over 200mmhg
boolean
C1319894 (UMLS CUI [1])
C4013784 (UMLS CUI [2])
Secondary hypertension
Item
patients with secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Kidney Disease Severe | Serum creatinine raised | Gastrointestinal Disease Severe | Hematological Disease Severe | Liver disease Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased | Investigational New Drug Absorption Affected | Investigational New Drug Disposition Affected | Investigational New Drug Metabolism Affected | Investigational New Drug Excretion Affected
Item
patients with severe renal(creatinine more 1.5 times than upper limit of normal), gastrointestinal, hematological or hepatic(ast, alt more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0700225 (UMLS CUI [2])
C0017178 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0018939 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0151904 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
C0013230 (UMLS CUI [8,1])
C0678745 (UMLS CUI [8,2])
C0392760 (UMLS CUI [8,3])
C0013230 (UMLS CUI [9,1])
C0678755 (UMLS CUI [9,2])
C0392760 (UMLS CUI [9,3])
C0013230 (UMLS CUI [10,1])
C0025520 (UMLS CUI [10,2])
C0392760 (UMLS CUI [10,3])
C0013230 (UMLS CUI [11,1])
C0683141 (UMLS CUI [11,2])
C0392760 (UMLS CUI [11,3])
Hypotension, Orthostatic
Item
patients with postural hypotension
boolean
C0020651 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Severe | Diabetic - poor control | Glycosylated hemoglobin A | Oral hypoglycemic | Therapy regimen changed | Insulin regime
Item
patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(hba1c>9%, regimen change of oral hypoglycemic agents within 3 months, treated insulin before screening)
boolean
C0011854 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0421258 (UMLS CUI [2])
C0019018 (UMLS CUI [3])
C0359086 (UMLS CUI [4])
C1141862 (UMLS CUI [5])
C0557978 (UMLS CUI [6])
Myocardial Infarction | Coronary Artery Disease Severe | Heart failure | Valvular defects
Item
patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
boolean
C0027051 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3])
C2748945 (UMLS CUI [4])
Cachexia | Autoimmune Diseases | Connective Tissue Diseases
Item
patients with consumptive disease, autoimmune disease, connective tissue disease
boolean
C0006625 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0009782 (UMLS CUI [3])
Hepatitis B | Hepatitis C
Item
patients with a history of type b or c hepatitis
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Infection | Hepatitis
Item
patients with hiv or hepatitis
boolean
C0019693 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
Laboratory test result abnormal
Item
patients with clinically significant laboratory abnormality
boolean
C0438215 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Blood Pressure | Therapeutic procedure Affecting Blood Pressure
Item
patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0005823 (UMLS CUI [2,3])
Allergy to angiotensin II receptor antagonist | Medical contraindication Angiotensin II receptor antagonist
Item
patients with allergy or contraindication to any angiotensin ii receptor antagonists
boolean
C2585204 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0521942 (UMLS CUI [2,2])
Childbearing Potential Hysterectomy Lacking | Childbearing Potential Postmenopausal state Absent
Item
female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
boolean
C3831118 (UMLS CUI [1,1])
C0020699 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Substance Use Disorders
Item
patients judged to have a history of alcohol or drug abuse by the investigator
boolean
C0038586 (UMLS CUI [1])
Body Weight Average
Item
patients with average weight > +35% or <-15% in modified metropolitan life insurance table
boolean
C0005910 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patients participated other clinical trial 3 months before screening
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
patients judged to be inappropriate for this study by the investigator with other reasons
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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