ID

24446

Beschreibung

A Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00696384

Link

https://clinicaltrials.gov/show/NCT00696384

Stichworte

Versionen (1)
  1. 01.08.17 01.08.17 -
Hochgeladen am

1. August 2017

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension NCT00696384

Englisch

Eligibility Hypertension NCT00696384

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. has essential hypertension (diastolic blood pressure ≥ 95mm hg and ≤ 119 mm hg. for participants with diabetes or chronic kidney disease diastolic blood pressure must be
Beschreibung

Essential Hypertension | Diastolic blood pressure | Diabetes Mellitus | Chronic Kidney Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0011849
UMLS CUI [4]
C1561643
≥ 85 mm hg and ≤ to 109 mm hg.
Beschreibung

Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0428883
2. female participant is not of childbearing potential (eg, sterilized, postmenopausal).
Beschreibung

Gender Infertility | Female Sterilization | Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0021359
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
3. female participants of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
Beschreibung

Childbearing Potential Sexually active Contraceptive methods | Pregnancy Absent | Breast Feeding Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
4. clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) are within the reference range for the testing laboratory unless the results are deemed not clinically significant for inclusion into this study by the investigator.
Beschreibung

Laboratory data interpretation Within Reference Range | Clinical Chemistry Within Reference Range | Hematology Within Reference Range | Urinalysis complete status Within Reference Range

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262707
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C0086715
UMLS CUI [2,1]
C0525044
UMLS CUI [2,2]
C0332285
UMLS CUI [2,3]
C0086715
UMLS CUI [3,1]
C0200627
UMLS CUI [3,2]
C0332285
UMLS CUI [3,3]
C0086715
UMLS CUI [4,1]
C1545793
UMLS CUI [4,2]
C0332285
UMLS CUI [4,3]
C0086715
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. systolic blood pressure greater than 185 mm hg.
Beschreibung

Systolic Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
2. is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Beschreibung

Illicit drug use Interferes with Evaluation Investigational New Drugs | Pharmaceutical Preparations prescribed Interfere with Evaluation Investigational New Drugs | Phytotherapy Interferes with Evaluation Investigational New Drugs | Non-Prescription Drugs Interfere with Evaluation Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0278329
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C1261322
UMLS CUI [2,5]
C0013230
UMLS CUI [3,1]
C0242388
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1261322
UMLS CUI [3,4]
C0013230
UMLS CUI [4,1]
C0013231
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C0013230
3. is hypersensitive to aii receptor blockers.
Beschreibung

Hypersensitivity Angiotensin II receptor antagonist

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0521942
4. recent history (within the last 6 months) of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, cerebrovascular accident, or transient ischemic attack.
Beschreibung

Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
UMLS CUI [4]
C1532338
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
5. history of moderate to severe heart failure or hypertensive encephalopathy.
Beschreibung

Heart failure Moderate | Heart failure Severe | Hypertensive Encephalopathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0151620
6. has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome).
Beschreibung

Conduction disorder of the heart | Complete atrioventricular block | Sick Sinus Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0264886
UMLS CUI [2]
C0151517
UMLS CUI [3]
C0037052
7. has secondary hypertension of any etiology.
Beschreibung

Secondary hypertension Etiology Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C1552551
8. known or suspected unilateral or bilateral renal artery stenosis.
Beschreibung

Unilateral renal artery stenosis | Bilateral renal artery stenosis | Unilateral renal artery stenosis Suspected | Bilateral renal artery stenosis Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0856759
UMLS CUI [2]
C0856760
UMLS CUI [3,1]
C0856759
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0856760
UMLS CUI [4,2]
C0750491
9. has severe renal dysfunction or disease (based on calculated creatinine clearance < 30 ml/min/1.73 m2) at screening.
Beschreibung

Renal dysfunction Severe | Kidney Disease Severe | Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C2711451
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Ähnliche Modelle

Eligibility Hypertension NCT00696384

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension | Diastolic blood pressure | Diabetes Mellitus | Chronic Kidney Disease
Item
1. has essential hypertension (diastolic blood pressure ≥ 95mm hg and ≤ 119 mm hg. for participants with diabetes or chronic kidney disease diastolic blood pressure must be
boolean
C0085580 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C1561643 (UMLS CUI [4])
Diastolic blood pressure
Item
≥ 85 mm hg and ≤ to 109 mm hg.
boolean
C0428883 (UMLS CUI [1])
Gender Infertility | Female Sterilization | Postmenopausal state
Item
2. female participant is not of childbearing potential (eg, sterilized, postmenopausal).
boolean
C0079399 (UMLS CUI [1,1])
C0021359 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Childbearing Potential Sexually active Contraceptive methods | Pregnancy Absent | Breast Feeding Absent
Item
3. female participants of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Laboratory data interpretation Within Reference Range | Clinical Chemistry Within Reference Range | Hematology Within Reference Range | Urinalysis complete status Within Reference Range
Item
4. clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) are within the reference range for the testing laboratory unless the results are deemed not clinically significant for inclusion into this study by the investigator.
boolean
C0262707 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0525044 (UMLS CUI [2,1])
C0332285 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,3])
C0200627 (UMLS CUI [3,1])
C0332285 (UMLS CUI [3,2])
C0086715 (UMLS CUI [3,3])
C1545793 (UMLS CUI [4,1])
C0332285 (UMLS CUI [4,2])
C0086715 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure
Item
1. systolic blood pressure greater than 185 mm hg.
boolean
C0871470 (UMLS CUI [1])
Illicit drug use Interferes with Evaluation Investigational New Drugs | Pharmaceutical Preparations prescribed Interfere with Evaluation Investigational New Drugs | Phytotherapy Interferes with Evaluation Investigational New Drugs | Non-Prescription Drugs Interfere with Evaluation Investigational New Drugs
Item
2. is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
boolean
C0281875 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0278329 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C1261322 (UMLS CUI [2,4])
C0013230 (UMLS CUI [2,5])
C0242388 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0013231 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
Hypersensitivity Angiotensin II receptor antagonist
Item
3. is hypersensitive to aii receptor blockers.
boolean
C0020517 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Cerebrovascular accident | Transient Ischemic Attack
Item
4. recent history (within the last 6 months) of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, cerebrovascular accident, or transient ischemic attack.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
Heart failure Moderate | Heart failure Severe | Hypertensive Encephalopathy
Item
5. history of moderate to severe heart failure or hypertensive encephalopathy.
boolean
C0018801 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151620 (UMLS CUI [3])
Conduction disorder of the heart | Complete atrioventricular block | Sick Sinus Syndrome
Item
6. has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome).
boolean
C0264886 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0037052 (UMLS CUI [3])
Secondary hypertension Etiology Any
Item
7. has secondary hypertension of any etiology.
boolean
C0155616 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Unilateral renal artery stenosis | Bilateral renal artery stenosis | Unilateral renal artery stenosis Suspected | Bilateral renal artery stenosis Suspected
Item
8. known or suspected unilateral or bilateral renal artery stenosis.
boolean
C0856759 (UMLS CUI [1])
C0856760 (UMLS CUI [2])
C0856759 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0856760 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Renal dysfunction Severe | Kidney Disease Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
9. has severe renal dysfunction or disease (based on calculated creatinine clearance < 30 ml/min/1.73 m2) at screening.
boolean
C3279454 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2711451 (UMLS CUI [3])
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