ID

24437

Description

Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina; ODM derived from: https://clinicaltrials.gov/show/NCT00507845

Link

https://clinicaltrials.gov/show/NCT00507845

Keywords

  1. 7/31/17 7/31/17 -
Uploaded on

July 31, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Hypertension NCT00507845

Eligibility Hypertension NCT00507845

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatient
Description

Outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
patients who couldn´t control their hypertension after 6 weeks of treatment with monotherapy (calcium blockers, beta blockers, diuretics, ace inhibitors, at2 blockers)(uncontrolled hypertension).
Description

Uncontrolled hypertension | Therapeutic procedure Pharmaceutical Preparation Single | Calcium Channel Blockers | Adrenergic beta-Antagonists | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0205171
UMLS CUI [3]
C0006684
UMLS CUI [4]
C0001645
UMLS CUI [5]
C0012798
UMLS CUI [6]
C0003015
UMLS CUI [7]
C0521942
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
already on fixed-dose combination treatment for hypertension
Description

Combined Modality Therapy Dose Stable Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0020538
contraindication to angiotensin converting enzyme (ace) inhibitors or ccb therapy
Description

Medical contraindication Angiotensin-Converting Enzyme Inhibitors | Medical contraindication Calcium Channel Blockers

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003015
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0006684
known hypersensitivity to felodipine (or other dihydropyridines), ramipril, other ace or any of the excipients of ramipril felodipine.
Description

Felodipine allergy | Hypersensitivity Dihydropyridines | Ramipril allergy | Angiotensin-converting-enzyme inhibitor allergy | Hypersensitivity Felodipine Excipient | Hypersensitivity Ramipril Excipient

Data type

boolean

Alias
UMLS CUI [1]
C0570918
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0012315
UMLS CUI [3]
C0571943
UMLS CUI [4]
C0571939
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0015772
UMLS CUI [5,3]
C0015237
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0072973
UMLS CUI [6,3]
C0015237
history of angioedema
Description

Angioedema

Data type

boolean

Alias
UMLS CUI [1]
C0002994
unstable haemodynamic conditions: cardiovascular shock, untreated heart failure, acute myocardial infarction, unstable angina pectoris, stroke.
Description

Hemodynamics Unstable | Shock, Cardiogenic | Heart failure untreated | Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1,1]
C0019010
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0036980
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C0332155
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0038454
patients with av block ii or iii
Description

Second degree atrioventricular block | Complete atrioventricular block

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
severely impaired hepatic function.
Description

Liver Dysfunction Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
pre-existing bilateral renal artery stenosis or stenosis of the artery to a solitary kidney
Description

Bilateral renal artery stenosis Pre-existing | Stricture of artery Single kidney

Data type

boolean

Alias
UMLS CUI [1,1]
C0856760
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0038449
UMLS CUI [2,2]
C1849176
pregnant and lactating mothers
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients on dialysis or haemofiltration.
Description

Dialysis | Hemofiltration

Data type

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2]
C0019014
patients with creatinine clearance < 20ml/min
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
use of potassium sparing diuretics
Description

Potassium Sparing Diuretics

Data type

boolean

Alias
UMLS CUI [1]
C0304490
severe hypertension (sbp ≥ 180 mmhg or dbp ≥ 110 mmhg)
Description

Hypertension, severe | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Hypertension NCT00507845

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients
Item
outpatient
boolean
C0029921 (UMLS CUI [1])
Uncontrolled hypertension | Therapeutic procedure Pharmaceutical Preparation Single | Calcium Channel Blockers | Adrenergic beta-Antagonists | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
patients who couldn´t control their hypertension after 6 weeks of treatment with monotherapy (calcium blockers, beta blockers, diuretics, ace inhibitors, at2 blockers)(uncontrolled hypertension).
boolean
C1868885 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0006684 (UMLS CUI [3])
C0001645 (UMLS CUI [4])
C0012798 (UMLS CUI [5])
C0003015 (UMLS CUI [6])
C0521942 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Combined Modality Therapy Dose Stable Hypertensive disease
Item
already on fixed-dose combination treatment for hypertension
boolean
C0009429 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0020538 (UMLS CUI [1,4])
Medical contraindication Angiotensin-Converting Enzyme Inhibitors | Medical contraindication Calcium Channel Blockers
Item
contraindication to angiotensin converting enzyme (ace) inhibitors or ccb therapy
boolean
C1301624 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0006684 (UMLS CUI [2,2])
Felodipine allergy | Hypersensitivity Dihydropyridines | Ramipril allergy | Angiotensin-converting-enzyme inhibitor allergy | Hypersensitivity Felodipine Excipient | Hypersensitivity Ramipril Excipient
Item
known hypersensitivity to felodipine (or other dihydropyridines), ramipril, other ace or any of the excipients of ramipril felodipine.
boolean
C0570918 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0012315 (UMLS CUI [2,2])
C0571943 (UMLS CUI [3])
C0571939 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0015772 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0072973 (UMLS CUI [6,2])
C0015237 (UMLS CUI [6,3])
Angioedema
Item
history of angioedema
boolean
C0002994 (UMLS CUI [1])
Hemodynamics Unstable | Shock, Cardiogenic | Heart failure untreated | Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
unstable haemodynamic conditions: cardiovascular shock, untreated heart failure, acute myocardial infarction, unstable angina pectoris, stroke.
boolean
C0019010 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0036980 (UMLS CUI [2])
C0018801 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
Second degree atrioventricular block | Complete atrioventricular block
Item
patients with av block ii or iii
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Liver Dysfunction Severe
Item
severely impaired hepatic function.
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Bilateral renal artery stenosis Pre-existing | Stricture of artery Single kidney
Item
pre-existing bilateral renal artery stenosis or stenosis of the artery to a solitary kidney
boolean
C0856760 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0038449 (UMLS CUI [2,1])
C1849176 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant and lactating mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Dialysis | Hemofiltration
Item
patients on dialysis or haemofiltration.
boolean
C0011946 (UMLS CUI [1])
C0019014 (UMLS CUI [2])
Creatinine clearance measurement
Item
patients with creatinine clearance < 20ml/min
boolean
C0373595 (UMLS CUI [1])
Potassium Sparing Diuretics
Item
use of potassium sparing diuretics
boolean
C0304490 (UMLS CUI [1])
Hypertension, severe | Systolic Pressure | Diastolic blood pressure
Item
severe hypertension (sbp ≥ 180 mmhg or dbp ≥ 110 mmhg)
boolean
C4013784 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])

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