ID

44244

Beschreibung

Olmesartan on Ambulatory Blood Pressure Change; ODM derived from: https://clinicaltrials.gov/show/NCT00854763

Link

https://clinicaltrials.gov/show/NCT00854763

Stichworte

Versionen (2)
  1. 02.05.18 02.05.18 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hypertension NCT00854763

Englisch

Eligibility Hypertension NCT00854763

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, 18 years of age or over.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
naïve patients with stage i** or stage ii** (jnc vii) essential hypertension or patients uncontrolled on current hypotensive drug therapy (in cuff bp>140/90mm hg)
Beschreibung

Therapy naive Essential Hypertension Stage | Antihypertensive therapy Absent | Blood pressure measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0085580
UMLS CUI [1,3]
C0699749
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0005824
all selected patients must give their written informed consent before recording their personal data
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject with secondary form of hypertension
Beschreibung

Secondary hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0155616
subject is being treated or with unstable condition for disease of myocardial infarction, clinically decompensated congestive heart failure, angina pectoris, sick sinus syndrome, second or third degree atrioventricular block
Beschreibung

Myocardial Infarction Treated | DECOMPENSATED CONGESTIVE HEART FAILURE Treated | Angina Pectoris Treated | Sick Sinus Syndrome Treated | Second degree atrioventricular block Treated | Complete atrioventricular block Treated | Myocardial Infarction Unstable | DECOMPENSATED CONGESTIVE HEART FAILURE Unstable | Angina, Unstable | Sick Sinus Syndrome Unstable | Second degree atrioventricular block Unstable | Complete atrioventricular block Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0742746
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0037052
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0264906
UMLS CUI [5,2]
C1522326
UMLS CUI [6,1]
C0151517
UMLS CUI [6,2]
C1522326
UMLS CUI [7,1]
C0027051
UMLS CUI [7,2]
C0443343
UMLS CUI [8,1]
C0742746
UMLS CUI [8,2]
C0443343
UMLS CUI [9]
C0002965
UMLS CUI [10,1]
C0037052
UMLS CUI [10,2]
C0443343
UMLS CUI [11,1]
C0264906
UMLS CUI [11,2]
C0443343
UMLS CUI [12,1]
C0151517
UMLS CUI [12,2]
C0443343
subject with history of hypertensive encephalopathy, grade 3 or 4 hypertensive retinopathy within 3 months before entering this trial
Beschreibung

Hypertensive Encephalopathy | Hypertensive Retinopathy Grade

Datentyp

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2,1]
C0152132
UMLS CUI [2,2]
C0441800
subjects with a cerebrovascular accident within 6 months before entering this trial
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
subject with auto-immune disease
Beschreibung

Autoimmune Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
subject with uncontrolled endocrine diseases, such as hyperthyroidism, hypothyroidism, hypercorticism and hypocorticism
Beschreibung

Endocrine System Diseases Uncontrolled | Hyperthyroidism | Hypothyroidism | Adrenal Gland Hyperfunction | Adrenal gland hypofunction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0020676
UMLS CUI [4]
C0001622
UMLS CUI [5]
C0001623
subject with confirmed evidence of renal impairment (creatinine > 1.5 x upper limit of normal)
Beschreibung

Renal Insufficiency | Serum creatinine raised

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
subject with hyperkalemia with serum potassium > 5.5 meq/l
Beschreibung

Hyperkalemia | Serum potassium measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2]
C0302353
subject with terminal stage of malignant disease
Beschreibung

Malignant disease End-stage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442867
UMLS CUI [1,2]
C0205088
subject with substance abuse history
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
subject with gastrointestinal disease which can interfere the absorption of the oral medications
Beschreibung

Gastrointestinal Disease Interferes with Absorption Oral medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0175795
subject with any contraindication to the use of angiotensin ii receptor blocker or calcium channel blocker
Beschreibung

Medical contraindication Angiotensin II receptor antagonist | Medical contraindication Calcium Channel Blockers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0521942
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0006684
subject is pregnant or lactating
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
premenopausal subjects not taking reliable methods for contraceptives
Beschreibung

Premenopausal state Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
subject with any other serious disease considered by the investigator not in the condition to enter the trial
Beschreibung

Disease Serious | Study Subject Participation Status Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332196
subject is not able to comply to the protocol requirements
Beschreibung

Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
subject participated investigational drug trial within 3 months before entering this study
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Ähnliche Modelle

Eligibility Hypertension NCT00854763

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, 18 years of age or over.
boolean
C0001779 (UMLS CUI [1])
Therapy naive Essential Hypertension Stage | Antihypertensive therapy Absent | Blood pressure measurement
Item
naïve patients with stage i** or stage ii** (jnc vii) essential hypertension or patients uncontrolled on current hypotensive drug therapy (in cuff bp>140/90mm hg)
boolean
C0919936 (UMLS CUI [1,1])
C0085580 (UMLS CUI [1,2])
C0699749 (UMLS CUI [1,3])
C0585941 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0005824 (UMLS CUI [3])
Informed Consent
Item
all selected patients must give their written informed consent before recording their personal data
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension
Item
subject with secondary form of hypertension
boolean
C0155616 (UMLS CUI [1])
Myocardial Infarction Treated | DECOMPENSATED CONGESTIVE HEART FAILURE Treated | Angina Pectoris Treated | Sick Sinus Syndrome Treated | Second degree atrioventricular block Treated | Complete atrioventricular block Treated | Myocardial Infarction Unstable | DECOMPENSATED CONGESTIVE HEART FAILURE Unstable | Angina, Unstable | Sick Sinus Syndrome Unstable | Second degree atrioventricular block Unstable | Complete atrioventricular block Unstable
Item
subject is being treated or with unstable condition for disease of myocardial infarction, clinically decompensated congestive heart failure, angina pectoris, sick sinus syndrome, second or third degree atrioventricular block
boolean
C0027051 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0742746 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0037052 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0264906 (UMLS CUI [5,1])
C1522326 (UMLS CUI [5,2])
C0151517 (UMLS CUI [6,1])
C1522326 (UMLS CUI [6,2])
C0027051 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0742746 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0002965 (UMLS CUI [9])
C0037052 (UMLS CUI [10,1])
C0443343 (UMLS CUI [10,2])
C0264906 (UMLS CUI [11,1])
C0443343 (UMLS CUI [11,2])
C0151517 (UMLS CUI [12,1])
C0443343 (UMLS CUI [12,2])
Hypertensive Encephalopathy | Hypertensive Retinopathy Grade
Item
subject with history of hypertensive encephalopathy, grade 3 or 4 hypertensive retinopathy within 3 months before entering this trial
boolean
C0151620 (UMLS CUI [1])
C0152132 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
Cerebrovascular accident
Item
subjects with a cerebrovascular accident within 6 months before entering this trial
boolean
C0038454 (UMLS CUI [1])
Autoimmune Disease
Item
subject with auto-immune disease
boolean
C0004364 (UMLS CUI [1])
Endocrine System Diseases Uncontrolled | Hyperthyroidism | Hypothyroidism | Adrenal Gland Hyperfunction | Adrenal gland hypofunction
Item
subject with uncontrolled endocrine diseases, such as hyperthyroidism, hypothyroidism, hypercorticism and hypocorticism
boolean
C0014130 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0020550 (UMLS CUI [2])
C0020676 (UMLS CUI [3])
C0001622 (UMLS CUI [4])
C0001623 (UMLS CUI [5])
Renal Insufficiency | Serum creatinine raised
Item
subject with confirmed evidence of renal impairment (creatinine > 1.5 x upper limit of normal)
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Hyperkalemia | Serum potassium measurement
Item
subject with hyperkalemia with serum potassium > 5.5 meq/l
boolean
C0020461 (UMLS CUI [1])
C0302353 (UMLS CUI [2])
Malignant disease End-stage
Item
subject with terminal stage of malignant disease
boolean
C0442867 (UMLS CUI [1,1])
C0205088 (UMLS CUI [1,2])
Substance Use Disorders
Item
subject with substance abuse history
boolean
C0038586 (UMLS CUI [1])
Gastrointestinal Disease Interferes with Absorption Oral medication
Item
subject with gastrointestinal disease which can interfere the absorption of the oral medications
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0175795 (UMLS CUI [1,4])
Medical contraindication Angiotensin II receptor antagonist | Medical contraindication Calcium Channel Blockers
Item
subject with any contraindication to the use of angiotensin ii receptor blocker or calcium channel blocker
boolean
C1301624 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0006684 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
subject is pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Premenopausal state Contraceptive methods Absent
Item
premenopausal subjects not taking reliable methods for contraceptives
boolean
C0232969 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Disease Serious | Study Subject Participation Status Excluded
Item
subject with any other serious disease considered by the investigator not in the condition to enter the trial
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Protocol Compliance Unable
Item
subject is not able to comply to the protocol requirements
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
subject participated investigational drug trial within 3 months before entering this study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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