ID

39961

Descrição

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

Link

https://clinicaltrials.gov/show/NCT01211314

Palavras-chave

Versões (1)
  1. 06/03/2020 06/03/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de março de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hypertension NCT01211314

Inglês

Eligibility Hypertension NCT01211314

1 Formulários  
Inclusion Criteria
Descrição

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
Descrição

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

Tipo de dados

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
Descrição

Gender

Tipo de dados

boolean

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

Age

Tipo de dados

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.
Descrição

Patient Eligible Therapeutic procedure | Lercanidipine hydrochloride

Tipo de dados

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
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

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)
Descrição

Antihypertensive Agents Quantity

Tipo de dados

boolean

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

Ambulatory Blood Pressure Monitoring Blood pressure determination mean

Tipo de dados

boolean

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

Pregnancy

Tipo de dados

boolean

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

Childbearing Potential

Tipo de dados

boolean

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

Secondary hypertension Suspected

Tipo de dados

boolean

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

Diabetic - poor control

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Congestive heart failure Requirement Pharmacotherapy

Tipo de dados

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]
Descrição

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

Tipo de dados

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.
Descrição

Malignant Neoplasms Requirement Chemotherapy

Tipo de dados

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.
Descrição

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

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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