ID

17663

Beschreibung

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

Stichworte

Versionen (1)
  1. 27.09.16 27.09.16 -
Hochgeladen am

27. September 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Hypertension NCT00185068

Englisch

Eligibility Hypertension NCT00185068

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Systolic hypertension disease stage

Datentyp

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.
Beschreibung

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

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
UMLS CUI [6]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack

Datentyp

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

Hypertension, severe | Diastolic blood pressure | Systolic Pressure

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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

Laboratory Results Clinical Significance

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0553723
UMLS CUI [3]
C0007117
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Hypertension NCT00185068

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video