ID

35863

Beschrijving

Efficacy and Safety of Azilsartan Compared to Olmesartan Medoxomil in Chinese Participants With Grade I or II Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02407210

Link

https://clinicaltrials.gov/show/NCT02407210

Trefwoorden

Versies (1)
  1. 29-03-19 29-03-19 -
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See clinicaltrials.gov

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29 maart 2019

DOI

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Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT02407210

Engels

Eligibility Essential Hypertension NCT02407210

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. both sexes. eighteen years or older and no more than 70 years at the time of informed consent
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. grade i or ii essential hypertension
Beschrijving

Essential Hypertension CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C1516728
3. both sitting systolic and diastolic blood pressures at week 0 during the run-in period meet the following criteria:
Beschrijving

Sitting systolic blood pressure Criteria Fulfill | Sitting diastolic blood pressure Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C1550543
sitting systolic blood pressure: greater than or equal to 150 mmhg and less than 180 mmhg
Beschrijving

Sitting systolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C1319893
sitting diastolic blood pressure: greater than or equal to 95 mmhg and less than 110 mmhg
Beschrijving

Sitting diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C1319894
4. able to understand the content of the study and comply with the study and to give informed consent in writing before participating in the study
Beschrijving

Comprehension Study Protocol | Protocol Compliance | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
UMLS CUI [3]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. secondary hypertension, grade iii hypertension (sitting systolic blood pressure greater than or equal to 180 mmhg or sitting diastolic blood pressure greater than or equal to 110 mmhg), or malignant hypertension，hypertensive emergencies，hypertensive urgencies
Beschrijving

Secondary hypertension | Hypertensive disease CTCAE Grades | Sitting systolic blood pressure | Sitting diastolic blood pressure | Malignant Hypertension | Hypertensive emergency | Hypertensive urgency

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C1516728
UMLS CUI [3]
C1319893
UMLS CUI [4]
C1319894
UMLS CUI [5]
C0020540
UMLS CUI [6]
C0745136
UMLS CUI [7]
C0745138
2. the following circulatory-related diseases or symptoms:
Beschrijving

Disorder of circulatory system | Symptoms circulatory system

Datatype

boolean

Alias
UMLS CUI [1]
C0728936
UMLS CUI [2]
C0476270
(1) cardiac disease: angina pectoris; valvular stenosis; atrial fibrillation; the following diseases requiring medication: congestive heart failure or arrhythmia； (2) cerebrovascular disorder: cerebral infarction, cerebral hemorrhage (onset within 24 weeks before start of the screening period), transient ischemic attack (onset of an attack within 24 weeks before start of the screening period)； (3) vascular disease: arteriosclerosis obliterans with symptoms of intermittent claudication； (4) progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema (observed within 24 weeks after start of the screening period)
Beschrijving

Heart Disease | Angina Pectoris | Valvular stenosis | Atrial Fibrillation | Disease Requirement Pharmaceutical Preparations | Congestive heart failure | Cardiac Arrhythmia | Cerebrovascular Disorders | Cerebral Infarction | Cerebral Hemorrhage | Transient Ischemic Attack | Vascular Diseases | Arteriosclerosis Obliterans | Symptoms Intermittent Claudication | Hypertensive Retinopathy Progressive | Hemorrhage | Exudation | Papilledema

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0002962
UMLS CUI [3]
C1883524
UMLS CUI [4]
C0004238
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0013227
UMLS CUI [6]
C0018802
UMLS CUI [7]
C0003811
UMLS CUI [8]
C0007820
UMLS CUI [9]
C0007785
UMLS CUI [10]
C2937358
UMLS CUI [11]
C0007787
UMLS CUI [12]
C0042373
UMLS CUI [13]
C0003851
UMLS CUI [14,1]
C1457887
UMLS CUI [14,2]
C0021775
UMLS CUI [15,1]
C0152132
UMLS CUI [15,2]
C0205329
UMLS CUI [16]
C0019080
UMLS CUI [17]
C0311437
UMLS CUI [18]
C0030353
3. decrease in sitting diastolic blood pressure by 8 mmhg or more at the end of the run-in period (week 0) compared to the start of the screening period
Beschrijving

Sitting diastolic blood pressure Decreased

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0392756
4. day/night reversal, e.g., nightshift worker
Beschrijving

Night shift worker

Datatype

boolean

Alias
UMLS CUI [1]
C0555008
5. unilateral or bilateral renal artery stenosis
Beschrijving

Unilateral renal artery stenosis | Bilateral renal artery stenosis

Datatype

boolean

Alias
UMLS CUI [1]
C0856759
UMLS CUI [2]
C0856760
6. clinically apparent hepatic and renal impairment (e.g., with ast and alt values of 2.5 x upper limit of normal or higher, with serum creatinine value of 1.5 x upper limit of normal or higher during the screening period)
Beschrijving

Hepatic impairment | Renal Insufficiency | Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0700225
7. hyperkalemia (with a laboratory value of 5.5 meq/l or higher during the run-in period)
Beschrijving

Hyperkalemia | Laboratory Results

Datatype

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2]
C1254595
8. malignant tumor
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
9. compliance with the study drug of less than 80% during the run-in period
Beschrijving

Compliance behavior Percentage Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0013230
10. poorly-controlled diabetes mellitus (fasting plasma glucose greater than 11mmol/l)，and/or complications (kidney disease, peripheral neuropathy) at screening.
Beschrijving

Poorly controlled diabetes mellitus | Plasma fasting glucose measurement | Complications | Kidney Disease | Peripheral Neuropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C0583513
UMLS CUI [3]
C0009566
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0031117
11. history of hypersensitivity or allergy to olmesartan medoxomil tablets and related drugs (arb, ace inhibitors, and renin inhibitors)
Beschrijving

Hypersensitivity Olmesartan medoxomil | Hypersensitivity Pharmaceutical Preparations Related | Allergy to angiotensin II receptor antagonist | Angiotensin-converting-enzyme inhibitor allergy | Hypersensitivity Renin inhibitor

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0386393
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [3]
C2585204
UMLS CUI [4]
C0571939
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1960108
12. history of drug abuse (defined as illegal drug use) or alcohol dependency within 2 years before start of the screening period
Beschrijving

Drug abuse | Illicit medication use | Alcoholic Intoxication, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0281875
UMLS CUI [3]
C0001973
13. requirement of the excluded treatment
Beschrijving

Requirement Therapeutic procedure Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332196
14. pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
15. participation in another clinical trial or post-marketing clinical trial within 30 days before start of the screening period
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
16. dangerous machinery operator such as aerial worker，motor vehicle driver
Beschrijving

Aviation Worker | Driver of motor vehicle

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004430
UMLS CUI [1,2]
C1306056
UMLS CUI [2]
C0336498
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Similar models

Eligibility Essential Hypertension NCT02407210

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. both sexes. eighteen years or older and no more than 70 years at the time of informed consent
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension CTCAE Grades
Item
2. grade i or ii essential hypertension
boolean
C0085580 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Sitting systolic blood pressure Criteria Fulfill | Sitting diastolic blood pressure Criteria Fulfill
Item
3. both sitting systolic and diastolic blood pressures at week 0 during the run-in period meet the following criteria:
boolean
C1319893 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1319894 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Sitting systolic blood pressure
Item
sitting systolic blood pressure: greater than or equal to 150 mmhg and less than 180 mmhg
boolean
C1319893 (UMLS CUI [1])
Sitting diastolic blood pressure
Item
sitting diastolic blood pressure: greater than or equal to 95 mmhg and less than 110 mmhg
boolean
C1319894 (UMLS CUI [1])
Comprehension Study Protocol | Protocol Compliance | Informed Consent
Item
4. able to understand the content of the study and comply with the study and to give informed consent in writing before participating in the study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Hypertensive disease CTCAE Grades | Sitting systolic blood pressure | Sitting diastolic blood pressure | Malignant Hypertension | Hypertensive emergency | Hypertensive urgency
Item
1. secondary hypertension, grade iii hypertension (sitting systolic blood pressure greater than or equal to 180 mmhg or sitting diastolic blood pressure greater than or equal to 110 mmhg), or malignant hypertension，hypertensive emergencies，hypertensive urgencies
boolean
C0155616 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3])
C1319894 (UMLS CUI [4])
C0020540 (UMLS CUI [5])
C0745136 (UMLS CUI [6])
C0745138 (UMLS CUI [7])
Disorder of circulatory system | Symptoms circulatory system
Item
2. the following circulatory-related diseases or symptoms:
boolean
C0728936 (UMLS CUI [1])
C0476270 (UMLS CUI [2])
Heart Disease | Angina Pectoris | Valvular stenosis | Atrial Fibrillation | Disease Requirement Pharmaceutical Preparations | Congestive heart failure | Cardiac Arrhythmia | Cerebrovascular Disorders | Cerebral Infarction | Cerebral Hemorrhage | Transient Ischemic Attack | Vascular Diseases | Arteriosclerosis Obliterans | Symptoms Intermittent Claudication | Hypertensive Retinopathy Progressive | Hemorrhage | Exudation | Papilledema
Item
(1) cardiac disease: angina pectoris; valvular stenosis; atrial fibrillation; the following diseases requiring medication: congestive heart failure or arrhythmia； (2) cerebrovascular disorder: cerebral infarction, cerebral hemorrhage (onset within 24 weeks before start of the screening period), transient ischemic attack (onset of an attack within 24 weeks before start of the screening period)； (3) vascular disease: arteriosclerosis obliterans with symptoms of intermittent claudication； (4) progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema (observed within 24 weeks after start of the screening period)
boolean
C0018799 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C1883524 (UMLS CUI [3])
C0004238 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C0018802 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0007820 (UMLS CUI [8])
C0007785 (UMLS CUI [9])
C2937358 (UMLS CUI [10])
C0007787 (UMLS CUI [11])
C0042373 (UMLS CUI [12])
C0003851 (UMLS CUI [13])
C1457887 (UMLS CUI [14,1])
C0021775 (UMLS CUI [14,2])
C0152132 (UMLS CUI [15,1])
C0205329 (UMLS CUI [15,2])
C0019080 (UMLS CUI [16])
C0311437 (UMLS CUI [17])
C0030353 (UMLS CUI [18])
Sitting diastolic blood pressure Decreased
Item
3. decrease in sitting diastolic blood pressure by 8 mmhg or more at the end of the run-in period (week 0) compared to the start of the screening period
boolean
C1319894 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
Night shift worker
Item
4. day/night reversal, e.g., nightshift worker
boolean
C0555008 (UMLS CUI [1])
Unilateral renal artery stenosis | Bilateral renal artery stenosis
Item
5. unilateral or bilateral renal artery stenosis
boolean
C0856759 (UMLS CUI [1])
C0856760 (UMLS CUI [2])
Hepatic impairment | Renal Insufficiency | Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum creatinine raised
Item
6. clinically apparent hepatic and renal impairment (e.g., with ast and alt values of 2.5 x upper limit of normal or higher, with serum creatinine value of 1.5 x upper limit of normal or higher during the screening period)
boolean
C0948807 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
Hyperkalemia | Laboratory Results
Item
7. hyperkalemia (with a laboratory value of 5.5 meq/l or higher during the run-in period)
boolean
C0020461 (UMLS CUI [1])
C1254595 (UMLS CUI [2])
Malignant Neoplasms
Item
8. malignant tumor
boolean
C0006826 (UMLS CUI [1])
Compliance behavior Percentage Investigational New Drugs
Item
9. compliance with the study drug of less than 80% during the run-in period
boolean
C1321605 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Poorly controlled diabetes mellitus | Plasma fasting glucose measurement | Complications | Kidney Disease | Peripheral Neuropathy
Item
10. poorly-controlled diabetes mellitus (fasting plasma glucose greater than 11mmol/l)，and/or complications (kidney disease, peripheral neuropathy) at screening.
boolean
C0554876 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
C0009566 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0031117 (UMLS CUI [5])
Hypersensitivity Olmesartan medoxomil | Hypersensitivity Pharmaceutical Preparations Related | Allergy to angiotensin II receptor antagonist | Angiotensin-converting-enzyme inhibitor allergy | Hypersensitivity Renin inhibitor
Item
11. history of hypersensitivity or allergy to olmesartan medoxomil tablets and related drugs (arb, ace inhibitors, and renin inhibitors)
boolean
C0020517 (UMLS CUI [1,1])
C0386393 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C2585204 (UMLS CUI [3])
C0571939 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C1960108 (UMLS CUI [5,2])
Drug abuse | Illicit medication use | Alcoholic Intoxication, Chronic
Item
12. history of drug abuse (defined as illegal drug use) or alcohol dependency within 2 years before start of the screening period
boolean
C0013146 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
C0001973 (UMLS CUI [3])
Requirement Therapeutic procedure Excluded
Item
13. requirement of the excluded treatment
boolean
C1514873 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
14. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
15. participation in another clinical trial or post-marketing clinical trial within 30 days before start of the screening period
boolean
C2348568 (UMLS CUI [1])
Aviation Worker | Driver of motor vehicle
Item
16. dangerous machinery operator such as aerial worker，motor vehicle driver
boolean
C0004430 (UMLS CUI [1,1])
C1306056 (UMLS CUI [1,2])
C0336498 (UMLS CUI [2])
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