ID

29991

Description

Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00922480

Lien

https://clinicaltrials.gov/show/NCT00922480

Mots-clés

Versions (1)
  1. 03/05/2018 03/05/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

3 mai 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hypertension NCT00922480

Anglais

Eligibility Hypertension NCT00922480

1 Formulaires  
Inclusion Criteria
Description

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.
Description

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

Type de données

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
UMLS CUI [4,1]
C1705242
UMLS CUI [4,2]
C1319894
UMLS CUI [4,3]
C0242485
subjects who agree to participate in this sudy and give written informed consent
Description

Informed Consent

Type de données

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
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

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
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C1319894
UMLS CUI [2]
C4013784
UMLS CUI [3]
C1319893
UMLS CUI [4]
C0155616
patients with severe renal(creatinine more 1.5 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
Description

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

Type de données

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]
C0205082
UMLS CUI [8,3]
C0392760
UMLS CUI [8,4]
C0678745
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C0205082
UMLS CUI [9,3]
C0392760
UMLS CUI [9,4]
C0678755
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0205082
UMLS CUI [10,3]
C0392760
UMLS CUI [10,4]
C0683140
UMLS CUI [11,1]
C0012634
UMLS CUI [11,2]
C0205082
UMLS CUI [11,3]
C0392760
UMLS CUI [11,4]
C0683141
patients with postural hypotension
Description

Hypotension, Orthostatic

Type de données

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)
Description

Insulin-Dependent Diabetes Mellitus Severe | Diabetic - poor control | Hemoglobin A1c measurement | Oral hypoglycemic Therapy change | Insulin regime

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0421258
UMLS CUI [3]
C0474680
UMLS CUI [4,1]
C0359086
UMLS CUI [4,2]
C3665894
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
Description

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

Type de données

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
Description

Tuberculosis, Pulmonary | Autoimmune Disease | Connective Tissue Disease

Type de données

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)
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0262505
UMLS CUI [4]
C0400920
patients with hiv or hepatitis
Description

HIV Infection | Hepatitis

Type de données

boolean

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

Laboratory test result abnormal

Type de données

boolean

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

Pharmaceutical Preparations Affecting Blood Pressure | Therapeutic procedure Influence Blood Pressure

Type de données

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
Description

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

Type de données

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
Description

Childbearing Potential Hysterectomy Absent | Childbearing Potential Postmenopausal state Absent

Type de données

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
Description

Substance Use Disorders

Type de données

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
Description

Study Subject Participation Status | Other Reason Study Subject Participation Status Inappropriate

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C3840932
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
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Similar models

Eligibility Hypertension NCT00922480

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension Mild | Essential Hypertension Moderate | Sitting diastolic blood pressure | Difference Sitting diastolic blood pressure Measurement
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])
C1705242 (UMLS CUI [4,1])
C1319894 (UMLS CUI [4,2])
C0242485 (UMLS CUI [4,3])
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 | Serum creatinine raised | Gastrointestinal Disease Severe | Hematological Disease Severe | Liver disease Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased | Disease Severe Affecting Drug absorption | Disease Severe Affecting Drug disposition | Disease Severe Affecting Drug metabolism | Disease Severe 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])
C0205082 (UMLS CUI [8,2])
C0392760 (UMLS CUI [8,3])
C0678745 (UMLS CUI [8,4])
C0012634 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0392760 (UMLS CUI [9,3])
C0678755 (UMLS CUI [9,4])
C0012634 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0392760 (UMLS CUI [10,3])
C0683140 (UMLS CUI [10,4])
C0012634 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C0392760 (UMLS CUI [11,3])
C0683141 (UMLS CUI [11,4])
Hypotension, Orthostatic
Item
patients with postural hypotension
boolean
C0020651 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Severe | Diabetic - poor control | Hemoglobin A1c measurement | Oral hypoglycemic Therapy 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])
C0474680 (UMLS CUI [3])
C0359086 (UMLS CUI [4,1])
C3665894 (UMLS CUI [4,2])
C0557978 (UMLS CUI [5])
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])
Tuberculosis, Pulmonary | 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 | Other Reason 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])
C3840932 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
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