ID

39961

Descrizione

Antihypertensive Efficacy of Fixed Combination Drug; ODM derived from: https://clinicaltrials.gov/show/NCT01211314

collegamento

https://clinicaltrials.gov/show/NCT01211314

Keywords

versioni (1)
  1. 06/03/20 06/03/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

6 marzo 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Hypertension NCT01211314

Inglese

Eligibility Hypertension NCT01211314

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. essential hypertension at visit 1 defined as office blood pressure <140/90 mmhg and a 24 h abpm >130/80 mmhg with a day time blood pressure (extracted from the 24h abpm) >135/85 mmhg
Descrizione

Essential Hypertension | Blood pressure determination | Blood Pressure Monitoring, Ambulatory | Blood pressure determination Daytime

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2]
C0005824
UMLS CUI [3]
C0242876
UMLS CUI [4,1]
C0005824
UMLS CUI [4,2]
C0332169
2. male and female
Descrizione

Gender

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0079399
3. age 18-80
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
4. every patient that in the medical opinion of the treating physician is eligible for vasodip combo 20 treatment.
Descrizione

Patient Eligible Therapeutic procedure | Lercanidipine hydrochloride

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0595331
5. willing to sign an informed consent
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. use of more than 2 anti hypertensive medication at visit 1 (fixed combination is considered as two drugs)
Descrizione

Antihypertensive Agents Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
2. mean 24 h abpm values of more than 180/100 mmhg
Descrizione

Ambulatory Blood Pressure Monitoring Blood pressure determination mean

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0242876
UMLS CUI [1,2]
C0005824
UMLS CUI [1,3]
C0444504
3. pregnant women
Descrizione

Pregnancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
4. women with potential age of pregnancy.
Descrizione

Childbearing Potential

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3831118
5. suspected secondary hypertension (investigator decision)
Descrizione

Secondary hypertension Suspected

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0750491
6. uncontrolled diabetes mellitus(investigator decision)
Descrizione

Diabetic - poor control

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0421258
7. any of the following in the last six months: myocardial infarction, stroke, coronary by-pass surgery, percutaneous coronariography with balloon dilation and/or stent insertion
Descrizione

Myocardial Infarction | Cerebrovascular accident | Coronary Artery Bypass Surgery | Coronary angiography Percutaneous | Balloon Dilatation | Placement of stent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0010055
UMLS CUI [4,1]
C0085532
UMLS CUI [4,2]
C0522523
UMLS CUI [5]
C0004704
UMLS CUI [6]
C0522776
8. congestive heart failure requiring pharmacological treatment
Descrizione

Congestive heart failure Requirement Pharmacotherapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
9. renal failure, defined as serum creatinine equal or great than 1.5 mg% [confirmed twice] or hyperkalemia defined as serum potassium equal or great that 5 meq/l [confirmed twice]
Descrizione

Kidney Failure | Creatinine measurement, serum | Hyperkalemia | Serum potassium measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0020461
UMLS CUI [4]
C0302353
10. malignancy that required chemotherapy in the last 3 years.
Descrizione

Malignant Neoplasms Requirement Chemotherapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0392920
11. any medical or none medical condition that in the eyes of the investigator will not allow the patient to complete the study.
Descrizione

Medical condition Preventing Completion of clinical trial | Condition Preventing Completion of clinical trial

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C2732579
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Similar models

Eligibility Hypertension NCT01211314

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension | Blood pressure determination | Blood Pressure Monitoring, Ambulatory | Blood pressure determination Daytime
Item
1. essential hypertension at visit 1 defined as office blood pressure <140/90 mmhg and a 24 h abpm >130/80 mmhg with a day time blood pressure (extracted from the 24h abpm) >135/85 mmhg
boolean
C0085580 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
C0242876 (UMLS CUI [3])
C0005824 (UMLS CUI [4,1])
C0332169 (UMLS CUI [4,2])
Gender
Item
2. male and female
boolean
C0079399 (UMLS CUI [1])
Age
Item
3. age 18-80
boolean
C0001779 (UMLS CUI [1])
Patient Eligible Therapeutic procedure | Lercanidipine hydrochloride
Item
4. every patient that in the medical opinion of the treating physician is eligible for vasodip combo 20 treatment.
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0595331 (UMLS CUI [2])
Informed Consent
Item
5. willing to sign an informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents Quantity
Item
1. use of more than 2 anti hypertensive medication at visit 1 (fixed combination is considered as two drugs)
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Ambulatory Blood Pressure Monitoring Blood pressure determination mean
Item
2. mean 24 h abpm values of more than 180/100 mmhg
boolean
C0242876 (UMLS CUI [1,1])
C0005824 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
Pregnancy
Item
3. pregnant women
boolean
C0032961 (UMLS CUI [1])
Childbearing Potential
Item
4. women with potential age of pregnancy.
boolean
C3831118 (UMLS CUI [1])
Secondary hypertension Suspected
Item
5. suspected secondary hypertension (investigator decision)
boolean
C0155616 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
Diabetic - poor control
Item
6. uncontrolled diabetes mellitus(investigator decision)
boolean
C0421258 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Coronary Artery Bypass Surgery | Coronary angiography Percutaneous | Balloon Dilatation | Placement of stent
Item
7. any of the following in the last six months: myocardial infarction, stroke, coronary by-pass surgery, percutaneous coronariography with balloon dilation and/or stent insertion
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C0085532 (UMLS CUI [4,1])
C0522523 (UMLS CUI [4,2])
C0004704 (UMLS CUI [5])
C0522776 (UMLS CUI [6])
Congestive heart failure Requirement Pharmacotherapy
Item
8. congestive heart failure requiring pharmacological treatment
boolean
C0018802 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
Kidney Failure | Creatinine measurement, serum | Hyperkalemia | Serum potassium measurement
Item
9. renal failure, defined as serum creatinine equal or great than 1.5 mg% [confirmed twice] or hyperkalemia defined as serum potassium equal or great that 5 meq/l [confirmed twice]
boolean
C0035078 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0020461 (UMLS CUI [3])
C0302353 (UMLS CUI [4])
Malignant Neoplasms Requirement Chemotherapy
Item
10. malignancy that required chemotherapy in the last 3 years.
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Medical condition Preventing Completion of clinical trial | Condition Preventing Completion of clinical trial
Item
11. any medical or none medical condition that in the eyes of the investigator will not allow the patient to complete the study.
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
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