ID

17663

Description

An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00185068

Link

https://clinicaltrials.gov/show/NCT00185068

Keywords

Versions (1)
  1. 9/27/16 9/27/16 -
Uploaded on

September 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00185068

English

Eligibility Hypertension NCT00185068

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with stage ii systolic hypertension
Description

Systolic hypertension disease stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0221155
UMLS CUI [1,2]
C0699749
3. 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.
Description

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

Data type

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
UMLS CUI [6]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hypertensive encephalopathy, stroke or transient ischemic attack (tia) within the past 6 months.
Description

Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
2. history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.
Description

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

Data type

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
3. severe hypertension (dbp greater than or equal to 110 mm hg or sbp > 200 mm hg).
Description

Hypertension, severe | Diastolic blood pressure | Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0871470
4. history of secondary hypertension including renal disease, phaeochromocytoma, or cushing's disease.
Description

Secondary hypertension | Kidney Diseases | Pheochromocytoma | Cushing's disease

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0031511
UMLS CUI [4]
C0221406
5. type i diabetes mellitus. 6. evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
Description

Diabetes Mellitus, Insulin-Dependent | Resting Bradycardia Symptomatic Evidence of | Congestive heart failure | Heart valve disease Hemodynamic Significant

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C3278174
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0332120
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0018824
UMLS CUI [4,2]
C0019010
UMLS CUI [4,3]
C0750502
7. presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, atrial fibrillation, or atrial flutter.
Description

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

Data type

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
8. laboratory test values considered clinically significant by the investigator.
Description

Laboratory Results Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2826293
9. evidence of liver disease as indicated by sgot or sgpt and/or total bilirubin > 3 times the upper limit of normal.
Description

Liver disease Evidence of | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C1278039
10. pregnant or lactating females.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
11. patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.
Description

Malignant Neoplasms | Squamous cell carcinoma of skin | Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0553723
UMLS CUI [3]
C0007117
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Similar models

Eligibility Hypertension NCT00185068

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Systolic hypertension disease stage
Item
2. patients with stage ii systolic hypertension
boolean
C0221155 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy | Tubal Ligation | Childbearing Potential Contraceptive methods | Informed Consent
Item
3. 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])
C0021430 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack
Item
1. hypertensive encephalopathy, stroke or transient ischemic attack (tia) within the past 6 months.
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Myocardial Infarction | Coronary revascularisation Transluminal Percutaneous | Coronary Artery Bypass Surgery | Angina, Unstable
Item
2. 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])
Hypertension, severe | Diastolic blood pressure | Systolic Pressure
Item
3. severe hypertension (dbp greater than or equal to 110 mm hg or sbp > 200 mm hg).
boolean
C4013784 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
Secondary hypertension | Kidney Diseases | Pheochromocytoma | Cushing's disease
Item
4. history of secondary hypertension including renal disease, phaeochromocytoma, or cushing's disease.
boolean
C0155616 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0031511 (UMLS CUI [3])
C0221406 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent | Resting Bradycardia Symptomatic Evidence of | Congestive heart failure | Heart valve disease Hemodynamic Significant
Item
5. type i diabetes mellitus. 6. evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
boolean
C0011854 (UMLS CUI [1])
C3278174 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0332120 (UMLS CUI [2,3])
C0018802 (UMLS CUI [3])
C0018824 (UMLS CUI [4,1])
C0019010 (UMLS CUI [4,2])
C0750502 (UMLS CUI [4,3])
Heart Block | First degree sinoatrial block | Wolff-Parkinson-White Syndrome | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter
Item
7. 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])
Laboratory Results Clinical Significance
Item
8. laboratory test values considered clinically significant by the investigator.
boolean
C1254595 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Liver disease Evidence of | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
9. evidence of liver disease as indicated by sgot or sgpt and/or total bilirubin > 3 times the upper limit of normal.
boolean
C0023895 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
10. pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms | Squamous cell carcinoma of skin | Basal cell carcinoma
Item
11. patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C0553723 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
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