ID

21076

Beschrijving

A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00430638

Link

https://clinicaltrials.gov/show/NCT00430638

Trefwoorden

Versies (1)
  1. 08-04-17 08-04-17 -
Geüploaded op

8 april 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT00430638

Engels

Eligibility Hypertension NCT00430638

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
greater than or equal to 18 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with a mean seated systolic blood pressure (mssbp) greater than or equal to 140 mmhg but less than or equal to 179 mmhg and a mean seated diastolic blood pressure (msdbp) less than or equal to 109 mmhg following a 3 to 4-week single-blind placebo run-in period.
Beschrijving

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Run-in Period Placebo Single-Blind

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C3274438
UMLS CUI [3,2]
C1696465
UMLS CUI [3,3]
C0037181
the difference in mssbp between visits 3 and 4 or between visits 4 and 4x must be less than or equal to 10 mmhg.
Beschrijving

Sitting systolic blood pressure mean Timepoint Difference

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C2348792
UMLS CUI [1,4]
C1705242
patients with a mean daytime (8am-4pm) systolic blood pressure (sbp) greater than or equal to 135 mmhg and less than or equal to 179 mmhg and a mean daytime diastolic blood pressure (dbp) less than or equal to 109 mmhg as measured by an ambulatory blood pressure monitoring device (abpm) following placebo run-in period.
Beschrijving

Systolic Pressure mean Daytime | Diastolic blood pressure mean Daytime | Blood Pressure Monitoring, Ambulatory | Run-in Period Placebo

Datatype

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C0332169
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0444504
UMLS CUI [2,3]
C0332169
UMLS CUI [3]
C0242876
UMLS CUI [4,1]
C3274438
UMLS CUI [4,2]
C1696465
if female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.
Beschrijving

Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy | Tubal Ligation | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0020699
UMLS CUI [4]
C0520483
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of stroke or transient ischemic attack (tia) within the last one year.
Beschrijving

Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
history of myocardial infarction, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
Beschrijving

Myocardial Infarction | Coronary angioplasty | Coronary Artery Bypass Surgery | Heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0190211
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0018801
patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or cushing's syndrome.
Beschrijving

Secondary hypertension Etiology Any | Kidney Diseases | Pheochromocytoma | Cushing Syndrome

Datatype

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C1552551
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0031511
UMLS CUI [4]
C0010481
type i diabetes. patients with type ii diabetes on stable treatment, with fasting glucose <160 mg/dl may enroll.
Beschrijving

Insulin-Dependent Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus Therapeutic procedure Stable | Glucose measurement, fasting

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0202045
patients with hemodynamically significant cardiac valvular disease.
Beschrijving

Heart valve disease Hemodynamic Significant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
patients with clinically significant cardiac conduction defects, including first, second or third degree av block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
Beschrijving

Conduction disorder of the heart | First degree atrioventricular block | Second degree atrioventricular block | Complete atrioventricular block | Left Bundle-Branch Block | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter | Accessory cardiac pathway | Cardiac Arrhythmia Requirement Pharmaceutical Preparations

Datatype

boolean

Alias
UMLS CUI [1]
C0264886
UMLS CUI [2]
C0085614
UMLS CUI [3]
C0264906
UMLS CUI [4]
C0151517
UMLS CUI [5]
C0023211
UMLS CUI [6]
C0037052
UMLS CUI [7]
C0004238
UMLS CUI [8]
C0004239
UMLS CUI [9]
C1963785
UMLS CUI [10,1]
C0003811
UMLS CUI [10,2]
C1514873
UMLS CUI [10,3]
C0013227
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Similar models

Eligibility Hypertension NCT00430638

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
greater than or equal to 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Run-in Period Placebo Single-Blind
Item
patients with a mean seated systolic blood pressure (mssbp) greater than or equal to 140 mmhg but less than or equal to 179 mmhg and a mean seated diastolic blood pressure (msdbp) less than or equal to 109 mmhg following a 3 to 4-week single-blind placebo run-in period.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C3274438 (UMLS CUI [3,1])
C1696465 (UMLS CUI [3,2])
C0037181 (UMLS CUI [3,3])
Sitting systolic blood pressure mean Timepoint Difference
Item
the difference in mssbp between visits 3 and 4 or between visits 4 and 4x must be less than or equal to 10 mmhg.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
C1705242 (UMLS CUI [1,4])
Systolic Pressure mean Daytime | Diastolic blood pressure mean Daytime | Blood Pressure Monitoring, Ambulatory | Run-in Period Placebo
Item
patients with a mean daytime (8am-4pm) systolic blood pressure (sbp) greater than or equal to 135 mmhg and less than or equal to 179 mmhg and a mean daytime diastolic blood pressure (dbp) less than or equal to 109 mmhg as measured by an ambulatory blood pressure monitoring device (abpm) following placebo run-in period.
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,3])
C0428883 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0332169 (UMLS CUI [2,3])
C0242876 (UMLS CUI [3])
C3274438 (UMLS CUI [4,1])
C1696465 (UMLS CUI [4,2])
Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy | Tubal Ligation | Childbearing Potential Contraceptive methods
Item
if female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.
boolean
C0079399 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0520483 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident | Transient Ischemic Attack
Item
history of stroke or transient ischemic attack (tia) within the last one year.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Myocardial Infarction | Coronary angioplasty | Coronary Artery Bypass Surgery | Heart failure
Item
history of myocardial infarction, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
boolean
C0027051 (UMLS CUI [1])
C0190211 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
Secondary hypertension Etiology Any | Kidney Diseases | Pheochromocytoma | Cushing Syndrome
Item
patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or cushing's syndrome.
boolean
C0155616 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2])
C0031511 (UMLS CUI [3])
C0010481 (UMLS CUI [4])
Insulin-Dependent Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus Therapeutic procedure Stable | Glucose measurement, fasting
Item
type i diabetes. patients with type ii diabetes on stable treatment, with fasting glucose <160 mg/dl may enroll.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0202045 (UMLS CUI [3])
Heart valve disease Hemodynamic Significant
Item
patients with hemodynamically significant cardiac valvular disease.
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Conduction disorder of the heart | First degree atrioventricular block | Second degree atrioventricular block | Complete atrioventricular block | Left Bundle-Branch Block | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter | Accessory cardiac pathway | Cardiac Arrhythmia Requirement Pharmaceutical Preparations
Item
patients with clinically significant cardiac conduction defects, including first, second or third degree av block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
boolean
C0264886 (UMLS CUI [1])
C0085614 (UMLS CUI [2])
C0264906 (UMLS CUI [3])
C0151517 (UMLS CUI [4])
C0023211 (UMLS CUI [5])
C0037052 (UMLS CUI [6])
C0004238 (UMLS CUI [7])
C0004239 (UMLS CUI [8])
C1963785 (UMLS CUI [9])
C0003811 (UMLS CUI [10,1])
C1514873 (UMLS CUI [10,2])
C0013227 (UMLS CUI [10,3])
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