ID

21072

Beskrivning

An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00412932

Länk

https://clinicaltrials.gov/show/NCT00412932

Nyckelord

Versioner (2)
  1. 2017-04-07 2017-04-07 -
  2. 2017-04-08 2017-04-08 -
Uppladdad den

7 april 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Hypertension NCT00412932

Engelsk

Eligibility Hypertension NCT00412932

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or females greater than 65 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with a mean seated systolic blood pressure (mssbp) greater than or equal to 150 mmhg but less than 200 mm hg and a mean seated diastolic blood pressure (msdbp) less than or equal to 109 mmhg following a 2-3 week single blind placebo run-in period.
Beskrivning

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

Datatyp

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
3. the difference in mssbp between visits 2 and 3 or between visits 3 and 3x must be less than or equal to 10 mmhg.
Beskrivning

Sitting systolic blood pressure mean Timepoint Difference

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C2348792
UMLS CUI [1,4]
C1705242
4. patients with a mean daytime (8am-4pm) systolic blood pressure (sbp) greater than or equal to 140 mmhg and less than or equal to 199 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.
Beskrivning

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

Datatyp

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
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

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

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0190211
UMLS CUI [4]
C0010055
UMLS CUI [5]
C0018801
3. severe hypertension (diastolic blood pressure greater than 115 mmhg or systolic blood pressure greater than or equal to 200 mmhg).
Beskrivning

Hypertension, severe | Diastolic blood pressure | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0871470
4. patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma or cushing's syndrome.
Beskrivning

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

Datatyp

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
5. type i diabetes or type ii diabetics not on stable treatment for greater than or equal to 4 weeks and plasma glucose greater than 160 mg/dl.
Beskrivning

Insulin-Dependent Diabetes Mellitus Therapeutic procedure Unstable | Non-Insulin-Dependent Diabetes Mellitus Therapeutic procedure Unstable | Plasma Glucose Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0443343
UMLS CUI [3]
C0202042
6. evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
Beskrivning

Bradycardia Resting Symptomatic | Congestive heart failure | Heart valve disease Hemodynamic Significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3278174
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0018802
UMLS CUI [3,1]
C0018824
UMLS CUI [3,2]
C0019010
UMLS CUI [3,3]
C0750502
7. presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, an accessory bypass tract, atrial fibrillation, atrial flutter or any arrhythmia requiring medication.
Beskrivning

Heart Block | First degree sinoatrial block | Wolff-Parkinson-White Syndrome | Sick Sinus Syndrome | Accessory cardiac pathway | Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia Requirement Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1]
C0018794
UMLS CUI [2]
C3854673
UMLS CUI [3]
C0043202
UMLS CUI [4]
C0037052
UMLS CUI [5]
C1963785
UMLS CUI [6]
C0004238
UMLS CUI [7]
C0004239
UMLS CUI [8,1]
C0003811
UMLS CUI [8,2]
C1514873
UMLS CUI [8,3]
C0013227
8. serum creatinine greater than 1.7 mg/dl, or other abnormal laboratory values deemed clinically significant by the investigator.
Beskrivning

Creatinine measurement, serum | Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0438215
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Similar models

Eligibility Hypertension NCT00412932

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. males or females greater than 65 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
2. patients with a mean seated systolic blood pressure (mssbp) greater than or equal to 150 mmhg but less than 200 mm hg and a mean seated diastolic blood pressure (msdbp) less than or equal to 109 mmhg following a 2-3 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
3. the difference in mssbp between visits 2 and 3 or between visits 3 and 3x 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
4. patients with a mean daytime (8am-4pm) systolic blood pressure (sbp) greater than or equal to 140 mmhg and less than or equal to 199 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])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident | Transient Ischemic Attack
Item
1. history of stroke or transient ischemic attack (tia) within the last one year.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Myocardial Infarction | Angina Pectoris | Coronary angioplasty | Coronary Artery Bypass Surgery | Heart failure
Item
2. history of myocardial infarction, angina, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0190211 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0018801 (UMLS CUI [5])
Hypertension, severe | Diastolic blood pressure | Systolic Pressure
Item
3. severe hypertension (diastolic blood pressure greater than 115 mmhg or systolic blood pressure greater than or equal to 200 mmhg).
boolean
C4013784 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
Secondary hypertension Etiology Any | Kidney Diseases | Pheochromocytoma | Cushing Syndrome
Item
4. 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 Therapeutic procedure Unstable | Non-Insulin-Dependent Diabetes Mellitus Therapeutic procedure Unstable | Plasma Glucose Measurement
Item
5. type i diabetes or type ii diabetics not on stable treatment for greater than or equal to 4 weeks and plasma glucose greater than 160 mg/dl.
boolean
C0011854 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0011860 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
C0202042 (UMLS CUI [3])
Bradycardia Resting Symptomatic | Congestive heart failure | Heart valve disease Hemodynamic Significant
Item
6. evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
boolean
C3278174 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0018824 (UMLS CUI [3,1])
C0019010 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
Heart Block | First degree sinoatrial block | Wolff-Parkinson-White Syndrome | Sick Sinus Syndrome | Accessory cardiac pathway | Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia Requirement Pharmaceutical Preparations
Item
7. presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, an accessory bypass tract, atrial fibrillation, atrial flutter or any arrhythmia requiring medication.
boolean
C0018794 (UMLS CUI [1])
C3854673 (UMLS CUI [2])
C0043202 (UMLS CUI [3])
C0037052 (UMLS CUI [4])
C1963785 (UMLS CUI [5])
C0004238 (UMLS CUI [6])
C0004239 (UMLS CUI [7])
C0003811 (UMLS CUI [8,1])
C1514873 (UMLS CUI [8,2])
C0013227 (UMLS CUI [8,3])
Creatinine measurement, serum | Laboratory test result abnormal
Item
8. serum creatinine greater than 1.7 mg/dl, or other abnormal laboratory values deemed clinically significant by the investigator.
boolean
C0201976 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
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