ID

21071

Beschreibung

An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00403481

Link

https://clinicaltrials.gov/show/NCT00403481

Stichworte

Versionen (2)
  1. 07.04.17 07.04.17 -
  2. 08.04.17 08.04.17 -
Hochgeladen am

7. April 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Hypertension NCT00403481

Englisch

Eligibility Hypertension NCT00403481

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with type ii diabetes that are on stable treatment with hypoglycemic agents
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0020616
UMLS CUI [2,2]
C0205360
patients with a mean seated systolic blood pressure (mssbp) greater than or equal to 140 mmhg but <200 mmhg and a msdbp less than or equal to 114 mmhg following a 3 to 4-week single-blind placebo run-in period
Beschreibung

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

Datentyp

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
Beschreibung

Sitting systolic blood pressure mean Timepoint Difference

Datentyp

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) sbp > 130 mmhg and less than or equal to 199 mmhg and a mean daytime dbp less than or equal to 114 as measured by an ambulatory blood pressure monitoring device (abpm) following placebo run-in period
Beschreibung

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

Datentyp

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, 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
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
Beschreibung

Myocardial Infarction | Coronary revascularisation Transluminal Percutaneous | Coronary Artery Bypass Surgery | Angina, Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0877341
UMLS CUI [2,2]
C0522520
UMLS CUI [2,3]
C0522523
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0002965
presence of overt proteinuria at screening
Beschreibung

Proteinuria

Datentyp

boolean

Alias
UMLS CUI [1]
C0033687
severe hypertension (dbp greater than or equal to 115 mmhg or sbp greater than or equal to 200 mmhg)
Beschreibung

Hypertension, severe | Diastolic blood pressure | Systolic Pressure

Datentyp

boolean

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

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

Datentyp

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 or type ii diabetes requiring insulin
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021641
evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease
Beschreibung

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

Datentyp

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
presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, atrial fibrillation, or atrial flutter
Beschreibung

Heart Block | First degree sinoatrial block | Wolff-Parkinson-White Syndrome | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter

Datentyp

boolean

Alias
UMLS CUI [1]
C0018794
UMLS CUI [2]
C3854673
UMLS CUI [3]
C0043202
UMLS CUI [4]
C0037052
UMLS CUI [5]
C0004238
UMLS CUI [6]
C0004239
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Ähnliche Modelle

Eligibility Hypertension NCT00403481

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents Stable
Item
patients diagnosed with type ii diabetes that are on stable treatment with hypoglycemic agents
boolean
C0011860 (UMLS CUI [1])
C0020616 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
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 <200 mmhg and a msdbp less than or equal to 114 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) sbp > 130 mmhg and less than or equal to 199 mmhg and a mean daytime dbp less than or equal to 114 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, 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 revascularisation Transluminal Percutaneous | Coronary Artery Bypass Surgery | Angina, Unstable
Item
history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
boolean
C0027051 (UMLS CUI [1])
C0877341 (UMLS CUI [2,1])
C0522520 (UMLS CUI [2,2])
C0522523 (UMLS CUI [2,3])
C0010055 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
Proteinuria
Item
presence of overt proteinuria at screening
boolean
C0033687 (UMLS CUI [1])
Hypertension, severe | Diastolic blood pressure | Systolic Pressure
Item
severe hypertension (dbp greater than or equal to 115 mmhg or sbp 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
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])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin
Item
type i or type ii diabetes requiring insulin
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
Bradycardia Resting Symptomatic | Congestive heart failure | Heart valve disease Hemodynamic Significant
Item
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 | Atrial Fibrillation | Atrial Flutter
Item
presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, atrial fibrillation, or atrial flutter
boolean
C0018794 (UMLS CUI [1])
C3854673 (UMLS CUI [2])
C0043202 (UMLS CUI [3])
C0037052 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0004239 (UMLS CUI [6])
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