ID

39207

Beskrivning

A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01258673

Länk

https://clinicaltrials.gov/show/NCT01258673

Nyckelord

Versioner (1)
  1. 2019-12-10 2019-12-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 december 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01258673

Engelsk

Eligibility Essential Hypertension NCT01258673

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female outpatients 18 years of age and older
Beskrivning

Outpatients | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with antihypertensive agents at screening: dbp<110mmhg or patients without antihypertensive agents at screening: dbp 90mmhg~120mmhg
Beskrivning

Antihypertensive Agents | Diastolic blood pressure | Antihypertensive Agents Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2]
C0428883
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0332197
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

Comprehension Study Protocol | Cooperative Behavior | Follow-up Able

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0009964
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C0085732
patients with not controlled blood pressure at baseline visit, by fimasartan 60mg 4weeks treatment, dbp 90mmhg~109mmhg and sbp<180mmhg
Beskrivning

Blood Pressure Uncontrolled | Fimasartan Dose | Diastolic blood pressure | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C2825622
UMLS CUI [2,2]
C0178602
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0871470
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the sitting dbp is more than 120mmhg or severe hypertensive patient with sitting systolic blood pressure over 200mmhg patients with secondary hypertension
Beskrivning

Sitting diastolic blood pressure | Severe Hypertension Sitting systolic blood pressure | Secondary hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1319894
UMLS CUI [2,1]
C4013784
UMLS CUI [2,2]
C1319893
UMLS CUI [3]
C0155616
patients who are measured the mean difference of mean blood pressure under sidbp 10mmhg or sisbp 20mmhg at screening or baseline visit
Beskrivning

Mean blood pressure Difference mean | Sitting diastolic blood pressure | Sitting systolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428886
UMLS CUI [1,2]
C1705242
UMLS CUI [1,3]
C0444504
UMLS CUI [2]
C1319894
UMLS CUI [3]
C1319893
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
Beskrivning

Kidney Disease Severe | Serum creatinine raised | Gastrointestinal Disease Severe | Hematological Disease Severe | Liver disease Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased | Disease Affecting Drug absorption | Disease Affecting Drug disposition | Disease Affecting Drug metabolism | Disease Affecting Drug elimination

Datatyp

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]
C0012634
UMLS CUI [8,2]
C0392760
UMLS CUI [8,3]
C0678745
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C0392760
UMLS CUI [9,3]
C0678755
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0392760
UMLS CUI [10,3]
C0683140
UMLS CUI [11,1]
C0012634
UMLS CUI [11,2]
C0392760
UMLS CUI [11,3]
C0683141
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 | Hemoglobin A1c measurement | Therapy change Oral hypoglycemic | Insulin regime Before Screening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0421258
UMLS CUI [3]
C0474680
UMLS CUI [4,1]
C3665894
UMLS CUI [4,2]
C0359086
UMLS CUI [5,1]
C0557978
UMLS CUI [5,2]
C0332152
UMLS CUI [5,3]
C0220908
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 | Valvular defects

Datatyp

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
Beskrivning

Phthisis | Autoimmune Disease | Connective Tissue Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0041327
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0009782
patients with a history of type b or c hepatitis(include carrier)
Beskrivning

Hepatitis B | Hepatitis C | Hepatitis B carrier | Hepatitis C carrier

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0262505
UMLS CUI [4]
C0400920
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 | Clinical Trial | Study Subject Participation Status Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C1548788
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Similar models

Eligibility Essential Hypertension NCT01258673

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male and female outpatients 18 years of age and older
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Antihypertensive Agents | Diastolic blood pressure | Antihypertensive Agents Absent
Item
patients with antihypertensive agents at screening: dbp<110mmhg or patients without antihypertensive agents at screening: dbp 90mmhg~120mmhg
boolean
C0003364 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0003364 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent
Item
subjects who agree to participate in this sudy and give written informed consent
boolean
C0021430 (UMLS CUI [1])
Comprehension Study Protocol | Cooperative Behavior | Follow-up Able
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])
C0009964 (UMLS CUI [2])
C3274571 (UMLS CUI [3,1])
C0085732 (UMLS CUI [3,2])
Blood Pressure Uncontrolled | Fimasartan Dose | Diastolic blood pressure | Systolic Pressure
Item
patients with not controlled blood pressure at baseline visit, by fimasartan 60mg 4weeks treatment, dbp 90mmhg~109mmhg and sbp<180mmhg
boolean
C0005823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C2825622 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3])
C0871470 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Sitting diastolic blood pressure | Severe Hypertension Sitting systolic blood pressure | Secondary hypertension
Item
the sitting dbp is more than 120mmhg or severe hypertensive patient with sitting systolic blood pressure over 200mmhg patients with secondary hypertension
boolean
C1319894 (UMLS CUI [1])
C4013784 (UMLS CUI [2,1])
C1319893 (UMLS CUI [2,2])
C0155616 (UMLS CUI [3])
Mean blood pressure Difference mean | Sitting diastolic blood pressure | Sitting systolic blood pressure
Item
patients who are measured the mean difference of mean blood pressure under sidbp 10mmhg or sisbp 20mmhg at screening or baseline visit
boolean
C0428886 (UMLS CUI [1,1])
C1705242 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C1319894 (UMLS CUI [2])
C1319893 (UMLS CUI [3])
Kidney Disease Severe | Serum creatinine raised | Gastrointestinal Disease Severe | Hematological Disease Severe | Liver disease Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased | Disease Affecting Drug absorption | Disease Affecting Drug disposition | Disease Affecting Drug metabolism | Disease Affecting Drug elimination
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])
C0012634 (UMLS CUI [8,1])
C0392760 (UMLS CUI [8,2])
C0678745 (UMLS CUI [8,3])
C0012634 (UMLS CUI [9,1])
C0392760 (UMLS CUI [9,2])
C0678755 (UMLS CUI [9,3])
C0012634 (UMLS CUI [10,1])
C0392760 (UMLS CUI [10,2])
C0683140 (UMLS CUI [10,3])
C0012634 (UMLS CUI [11,1])
C0392760 (UMLS CUI [11,2])
C0683141 (UMLS CUI [11,3])
Hypotension, Orthostatic
Item
patients with postural hypotension
boolean
C0020651 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Severe | Diabetic - poor control | Hemoglobin A1c measurement | Therapy change Oral hypoglycemic | Insulin regime Before Screening
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])
C0474680 (UMLS CUI [3])
C3665894 (UMLS CUI [4,1])
C0359086 (UMLS CUI [4,2])
C0557978 (UMLS CUI [5,1])
C0332152 (UMLS CUI [5,2])
C0220908 (UMLS CUI [5,3])
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])
Phthisis | Autoimmune Disease | Connective Tissue Disease
Item
patients with consumptive disease, autoimmune disease, connective tissue disease
boolean
C0041327 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0009782 (UMLS CUI [3])
Hepatitis B | Hepatitis C | Hepatitis B carrier | Hepatitis C carrier
Item
patients with a history of type b or c hepatitis(include carrier)
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0262505 (UMLS CUI [3])
C0400920 (UMLS CUI [4])
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 | Clinical Trial | 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])
C0008976 (UMLS CUI [2])
C2348568 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
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