ID

29343

Beskrivning

A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00922441

Länk

https://clinicaltrials.gov/show/NCT00922441

Nyckelord

Versioner (3)
  1. 2018-03-20 2018-03-20 -
  2. 2018-03-20 2018-03-20 -
  3. 2018-03-21 2018-03-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 mars 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Essential Hypertension NCT00922441

Engelsk

Eligibility Essential Hypertension NCT00922441

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
mild to moderate essential hypertension : sitting diastolic blood pressure measured at placebo visit and baseline are 90~109mmhg inclusive and the difference between sitting diastolic blood pressures measured at placebo visit and baseline(day0) is under 7mmhg.
Beskrivning

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

Datatyp

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
Beskrivning

Informed Consent

Datatyp

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
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the sitting dbp is less than 89mmhg or more than 110mmhg or severe hypertensive patient with sitting systolic blood pressure over 200mmhg patients with secondary hypertension
Beskrivning

Sitting diastolic blood pressure | Hypertension, severe | Sitting systolic blood pressure | Secondary hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1319894
UMLS CUI [2]
C4013784
UMLS CUI [3]
C1319893
UMLS CUI [4]
C0155616
patients with severe renal(creatinine more 1.5mg/dl), 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
Beskrivning

Kidney Disease Severe Affecting Absorption Investigational New Drugs | Creatinine measurement, serum | Gastrointestinal Disease Severe Affecting Absorption Investigational New Drugs | Hematological Disease Severe Affecting Absorption Investigational New Drugs | Liver disease Severe Affecting Absorption Investigational New Drugs | Aspartate aminotransferase increased | Alanine aminotransferase increased | Kidney Disease Severe Affecting Disposition Investigational New Drugs | Gastrointestinal Disease Severe Affecting Disposition Investigational New Drugs | Hematological Disease Severe Affecting Disposition Investigational New Drugs | Liver disease Severe Affecting Disposition Investigational New Drugs | Kidney Disease Severe Affecting Metabolism Investigational New Drugs | Gastrointestinal Disease Severe Affecting Metabolism Investigational New Drugs | Hematological Disease Severe Affecting Metabolism Investigational New Drugs | Liver disease Severe Affecting Metabolism Investigational New Drugs | Kidney Disease Severe Affecting Elimination Investigational New Drugs | Gastrointestinal Disease Severe Affecting Elimination Investigational New Drugs | Hematological Disease Severe Affecting Elimination Investigational New Drugs | Liver disease Severe Affecting Elimination Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0237442
UMLS CUI [1,5]
C0013230
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0392760
UMLS CUI [3,4]
C0237442
UMLS CUI [3,5]
C0013230
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0392760
UMLS CUI [4,4]
C0237442
UMLS CUI [4,5]
C0013230
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C0392760
UMLS CUI [5,4]
C0237442
UMLS CUI [5,5]
C0013230
UMLS CUI [6]
C0151904
UMLS CUI [7]
C0151905
UMLS CUI [8,1]
C0022658
UMLS CUI [8,2]
C0205082
UMLS CUI [8,3]
C0392760
UMLS CUI [8,4]
C0678755
UMLS CUI [8,5]
C0013230
UMLS CUI [9,1]
C0017178
UMLS CUI [9,2]
C0205082
UMLS CUI [9,3]
C0392760
UMLS CUI [9,4]
C0678755
UMLS CUI [9,5]
C0013230
UMLS CUI [10,1]
C0018939
UMLS CUI [10,2]
C0205082
UMLS CUI [10,3]
C0392760
UMLS CUI [10,4]
C0678755
UMLS CUI [10,5]
C0013230
UMLS CUI [11,1]
C0023895
UMLS CUI [11,2]
C0205082
UMLS CUI [11,3]
C0392760
UMLS CUI [11,4]
C0678755
UMLS CUI [11,5]
C0013230
UMLS CUI [12,1]
C0022658
UMLS CUI [12,2]
C0205082
UMLS CUI [12,3]
C0392760
UMLS CUI [12,4]
C0683140
UMLS CUI [12,5]
C0013230
UMLS CUI [13,1]
C0017178
UMLS CUI [13,2]
C0205082
UMLS CUI [13,3]
C0392760
UMLS CUI [13,4]
C0683140
UMLS CUI [13,5]
C0013230
UMLS CUI [14,1]
C0018939
UMLS CUI [14,2]
C0205082
UMLS CUI [14,3]
C0392760
UMLS CUI [14,4]
C0683140
UMLS CUI [14,5]
C0013230
UMLS CUI [15,1]
C0023895
UMLS CUI [15,2]
C0205082
UMLS CUI [15,3]
C0392760
UMLS CUI [15,4]
C0683140
UMLS CUI [15,5]
C0013230
UMLS CUI [16,1]
C0022658
UMLS CUI [16,2]
C0205082
UMLS CUI [16,3]
C0392760
UMLS CUI [16,4]
C0683141
UMLS CUI [16,5]
C0013230
UMLS CUI [17,1]
C0017178
UMLS CUI [17,2]
C0205082
UMLS CUI [17,3]
C0392760
UMLS CUI [17,4]
C0683141
UMLS CUI [17,5]
C0013230
UMLS CUI [18,1]
C0018939
UMLS CUI [18,2]
C0205082
UMLS CUI [18,3]
C0392760
UMLS CUI [18,4]
C0683141
UMLS CUI [18,5]
C0013230
UMLS CUI [19,1]
C0023895
UMLS CUI [19,2]
C0205082
UMLS CUI [19,3]
C0392760
UMLS CUI [19,4]
C0683141
UMLS CUI [19,5]
C0013230
patients with postural hypotension
Beskrivning

Hypotension, Orthostatic

Datatyp

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 12weeks, treated insulin before screening)
Beskrivning

Insulin-Dependent Diabetes Mellitus Severe | Diabetic - poor control | Glucohemoglobin measurement | ORAL HYPOGLYCEMIC TREATMENT Change | Insulin regime

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0421258
UMLS CUI [3]
C0202054
UMLS CUI [4,1]
C0747045
UMLS CUI [4,2]
C0392747
UMLS CUI [5]
C0557978
patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
Beskrivning

Myocardial Infarction | Coronary Artery Disease Severe | Heart failure | Heart valve defect

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0744705
patients with consumptive disease, autoimmune disease, connective tissue disease
Beskrivning

Disease cachectic | Autoimmune Diseases | Connective Tissue Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0006625
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0009782
patients with a history of type b or c hepatitis
Beskrivning

Hepatitis B | Hepatitis C

Datatyp

boolean

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

HIV Infection | Hepatitis

Datatyp

boolean

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

Laboratory test result abnormal

Datatyp

boolean

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

Pharmaceutical Preparations Affecting Blood Pressure | Therapeutic procedure Influence Blood Pressure

Datatyp

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]
C4054723
UMLS CUI [2,3]
C0005823
patients with allergy or contraindication to any angiotensin ii receptor antagonists
Beskrivning

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

Datatyp

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
Beskrivning

Childbearing Potential Hysterectomy Absent | Childbearing Potential Postmenopausal state Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0020699
UMLS CUI [1,3]
C0332197
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
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
patients participated other clinical trial 12 weeks before screening patients judged to be inappropriate for this study by the investigator with other reasons
Beskrivning

Study Subject Participation Status | Study Subject Participation Status Inappropriate

Datatyp

boolean

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

Eligibility Essential Hypertension NCT00922441

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 placebo visit and baseline are 90~109mmhg inclusive and the difference between sitting diastolic blood pressures measured at placebo visit and baseline(day0) 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])
Protocol Compliance
Item
subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Sitting diastolic blood pressure | Hypertension, severe | Sitting systolic blood pressure | Secondary hypertension
Item
the sitting dbp is less than 89mmhg or more than 110mmhg or severe hypertensive patient with sitting systolic blood pressure over 200mmhg patients with secondary hypertension
boolean
C1319894 (UMLS CUI [1])
C4013784 (UMLS CUI [2])
C1319893 (UMLS CUI [3])
C0155616 (UMLS CUI [4])
Kidney Disease Severe Affecting Absorption Investigational New Drugs | Creatinine measurement, serum | Gastrointestinal Disease Severe Affecting Absorption Investigational New Drugs | Hematological Disease Severe Affecting Absorption Investigational New Drugs | Liver disease Severe Affecting Absorption Investigational New Drugs | Aspartate aminotransferase increased | Alanine aminotransferase increased | Kidney Disease Severe Affecting Disposition Investigational New Drugs | Gastrointestinal Disease Severe Affecting Disposition Investigational New Drugs | Hematological Disease Severe Affecting Disposition Investigational New Drugs | Liver disease Severe Affecting Disposition Investigational New Drugs | Kidney Disease Severe Affecting Metabolism Investigational New Drugs | Gastrointestinal Disease Severe Affecting Metabolism Investigational New Drugs | Hematological Disease Severe Affecting Metabolism Investigational New Drugs | Liver disease Severe Affecting Metabolism Investigational New Drugs | Kidney Disease Severe Affecting Elimination Investigational New Drugs | Gastrointestinal Disease Severe Affecting Elimination Investigational New Drugs | Hematological Disease Severe Affecting Elimination Investigational New Drugs | Liver disease Severe Affecting Elimination Investigational New Drugs
Item
patients with severe renal(creatinine more 1.5mg/dl), 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])
C0392760 (UMLS CUI [1,3])
C0237442 (UMLS CUI [1,4])
C0013230 (UMLS CUI [1,5])
C0201976 (UMLS CUI [2])
C0017178 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C0237442 (UMLS CUI [3,4])
C0013230 (UMLS CUI [3,5])
C0018939 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0237442 (UMLS CUI [4,4])
C0013230 (UMLS CUI [4,5])
C0023895 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0392760 (UMLS CUI [5,3])
C0237442 (UMLS CUI [5,4])
C0013230 (UMLS CUI [5,5])
C0151904 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
C0022658 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0392760 (UMLS CUI [8,3])
C0678755 (UMLS CUI [8,4])
C0013230 (UMLS CUI [8,5])
C0017178 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0392760 (UMLS CUI [9,3])
C0678755 (UMLS CUI [9,4])
C0013230 (UMLS CUI [9,5])
C0018939 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0392760 (UMLS CUI [10,3])
C0678755 (UMLS CUI [10,4])
C0013230 (UMLS CUI [10,5])
C0023895 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C0392760 (UMLS CUI [11,3])
C0678755 (UMLS CUI [11,4])
C0013230 (UMLS CUI [11,5])
C0022658 (UMLS CUI [12,1])
C0205082 (UMLS CUI [12,2])
C0392760 (UMLS CUI [12,3])
C0683140 (UMLS CUI [12,4])
C0013230 (UMLS CUI [12,5])
C0017178 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0392760 (UMLS CUI [13,3])
C0683140 (UMLS CUI [13,4])
C0013230 (UMLS CUI [13,5])
C0018939 (UMLS CUI [14,1])
C0205082 (UMLS CUI [14,2])
C0392760 (UMLS CUI [14,3])
C0683140 (UMLS CUI [14,4])
C0013230 (UMLS CUI [14,5])
C0023895 (UMLS CUI [15,1])
C0205082 (UMLS CUI [15,2])
C0392760 (UMLS CUI [15,3])
C0683140 (UMLS CUI [15,4])
C0013230 (UMLS CUI [15,5])
C0022658 (UMLS CUI [16,1])
C0205082 (UMLS CUI [16,2])
C0392760 (UMLS CUI [16,3])
C0683141 (UMLS CUI [16,4])
C0013230 (UMLS CUI [16,5])
C0017178 (UMLS CUI [17,1])
C0205082 (UMLS CUI [17,2])
C0392760 (UMLS CUI [17,3])
C0683141 (UMLS CUI [17,4])
C0013230 (UMLS CUI [17,5])
C0018939 (UMLS CUI [18,1])
C0205082 (UMLS CUI [18,2])
C0392760 (UMLS CUI [18,3])
C0683141 (UMLS CUI [18,4])
C0013230 (UMLS CUI [18,5])
C0023895 (UMLS CUI [19,1])
C0205082 (UMLS CUI [19,2])
C0392760 (UMLS CUI [19,3])
C0683141 (UMLS CUI [19,4])
C0013230 (UMLS CUI [19,5])
Hypotension, Orthostatic
Item
patients with postural hypotension
boolean
C0020651 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Severe | Diabetic - poor control | Glucohemoglobin measurement | ORAL HYPOGLYCEMIC TREATMENT Change | Insulin regime
Item
patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(hba1c>9%, regimen change of oral hypoglycemic agents within 12weeks, treated insulin before screening)
boolean
C0011854 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0421258 (UMLS CUI [2])
C0202054 (UMLS CUI [3])
C0747045 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0557978 (UMLS CUI [5])
Myocardial Infarction | Coronary Artery Disease Severe | Heart failure | Heart valve defect
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])
C0744705 (UMLS CUI [4])
Disease cachectic | Autoimmune Diseases | Connective Tissue Diseases
Item
patients with consumptive disease, autoimmune disease, connective tissue disease
boolean
C0012634 (UMLS CUI [1,1])
C0006625 (UMLS CUI [1,2])
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 Influence 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])
C4054723 (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 Absent | 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])
C0332197 (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])
Study Subject Participation Status | Study Subject Participation Status Inappropriate
Item
patients participated other clinical trial 12 weeks before screening patients judged to be inappropriate for this study by the investigator with other reasons
boolean
C2348568 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
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