ID

36107

Description

Comparison of Losartan Associated With Indapamide Versus Indapamide for Treatment of Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01620788

Link

https://clinicaltrials.gov/show/NCT01620788

Keywords

Versions (1)
  1. 4/15/19 4/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01620788

English

Eligibility Hypertension NCT01620788

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults male or female aged ≥ 18 years old;
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
patients with a diagnosis of hypertension (defined by the medical investigator) treated with monotherapy or at least two blood pressure measurements ≥ 140/90, in a sitting position with a 5' interval between measurements,
Description

Therapy Hypertensive disease | Sitting blood pressure Measurement Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0020538
UMLS CUI [2,1]
C0580946
UMLS CUI [2,2]
C0242485
UMLS CUI [2,3]
C1265611
patients with normal lab tests results in the last six months or that the investigator consider not clinically significant,
Description

Normal Laboratory Test Result

Data type

boolean

Alias
UMLS CUI [1]
C0438214
patient who accept the discontinuation of previous hypertension therapy.
Description

Prior Therapy Hypertensive disease To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0020538
UMLS CUI [1,3]
C1272691
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with blood pressure ≥ 180/100 mmhg;
Description

Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0005824
patients with uncontrolled hypertension (≥ 140/90 mmhg) treated with thiazide diuretics;
Description

Uncontrolled hypertension | Thiazide Diuretics

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0012802
presence of concomitant coronary artery disease, congestive heart failure, diabetes and renal failure (creatinine> 1.5 mg / dl);
Description

Comorbidity | Coronary Artery Disease | Congestive heart failure | Diabetes Mellitus | Kidney Failure | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0035078
UMLS CUI [6]
C0201976
patients with hypo or hyperkalemia (serum potassium outside normal range);
Description

Hypokalemia | Hyperkalemia | Serum potassium abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0020621
UMLS CUI [2]
C0020461
UMLS CUI [3]
C0858156
patients with alt greater than 2.5 the upper limit of normal or active liver disease;
Description

Alanine aminotransferase increased | Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0023895
pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period;
Description

Pregnancy | Childbearing Potential Contraceptive methods Absent | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0032992
patients on drug or alcohol abuse in the last two years;
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
patients with secondary hypertension (renovascular disease, pheochromocytoma, cushing's syndrome);
Description

Secondary hypertension | Renal vascular disorder | Pheochromocytoma | Cushing Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0268790
UMLS CUI [3]
C0031511
UMLS CUI [4]
C0010481
patients with allergic reactions or hypersensitivity to ace inhibitors, diuretics or medications containing sulfa and / or any excipients of formulation;
Description

Allergic Reaction Angiotensin-Converting Enzyme Inhibitors | Angiotensin-converting-enzyme inhibitor allergy | Allergic Reaction Diuretics | Diuretic allergy | Allergic Reaction Pharmaceutical Preparations Containing Sulfa | Allergy to sulfonamides | Allergic Reaction Excipient Formulation | Hypersensitivity Excipient Formulation

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0003015
UMLS CUI [2]
C0571939
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0012798
UMLS CUI [4]
C0571893
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C0332256
UMLS CUI [5,4]
C0749139
UMLS CUI [6]
C0038757
UMLS CUI [7,1]
C1527304
UMLS CUI [7,2]
C0015237
UMLS CUI [7,3]
C1705957
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0015237
UMLS CUI [8,3]
C1705957
refusal or inability to provide the informed consent term.;
Description

Informed Consent Refused | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
refusal to discontinue the anti-hypertensive medication.
Description

Antihypertensive Agents Discontinue Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1705116
patients at the discretion of the investigator does not have indication for discontinuing the current medications;
Description

Absence Indication Discontinue Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C1444662
UMLS CUI [1,4]
C0013227
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Similar models

Eligibility Hypertension NCT01620788

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adults male or female aged ≥ 18 years old;
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Therapy Hypertensive disease | Sitting blood pressure Measurement Quantity
Item
patients with a diagnosis of hypertension (defined by the medical investigator) treated with monotherapy or at least two blood pressure measurements ≥ 140/90, in a sitting position with a 5' interval between measurements,
boolean
C0087111 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0580946 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Normal Laboratory Test Result
Item
patients with normal lab tests results in the last six months or that the investigator consider not clinically significant,
boolean
C0438214 (UMLS CUI [1])
Prior Therapy Hypertensive disease To be stopped
Item
patient who accept the discontinuation of previous hypertension therapy.
boolean
C1514463 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Blood pressure determination
Item
patients with blood pressure ≥ 180/100 mmhg;
boolean
C0005824 (UMLS CUI [1])
Uncontrolled hypertension | Thiazide Diuretics
Item
patients with uncontrolled hypertension (≥ 140/90 mmhg) treated with thiazide diuretics;
boolean
C1868885 (UMLS CUI [1])
C0012802 (UMLS CUI [2])
Comorbidity | Coronary Artery Disease | Congestive heart failure | Diabetes Mellitus | Kidney Failure | Creatinine measurement, serum
Item
presence of concomitant coronary artery disease, congestive heart failure, diabetes and renal failure (creatinine> 1.5 mg / dl);
boolean
C0009488 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0035078 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Hypokalemia | Hyperkalemia | Serum potassium abnormal
Item
patients with hypo or hyperkalemia (serum potassium outside normal range);
boolean
C0020621 (UMLS CUI [1])
C0020461 (UMLS CUI [2])
C0858156 (UMLS CUI [3])
Alanine aminotransferase increased | Liver disease
Item
patients with alt greater than 2.5 the upper limit of normal or active liver disease;
boolean
C0151905 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Pregnancy | Childbearing Potential Contraceptive methods Absent | Pregnancy, Planned
Item
pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period;
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0032992 (UMLS CUI [3])
Substance Use Disorders
Item
patients on drug or alcohol abuse in the last two years;
boolean
C0038586 (UMLS CUI [1])
Secondary hypertension | Renal vascular disorder | Pheochromocytoma | Cushing Syndrome
Item
patients with secondary hypertension (renovascular disease, pheochromocytoma, cushing's syndrome);
boolean
C0155616 (UMLS CUI [1])
C0268790 (UMLS CUI [2])
C0031511 (UMLS CUI [3])
C0010481 (UMLS CUI [4])
Allergic Reaction Angiotensin-Converting Enzyme Inhibitors | Angiotensin-converting-enzyme inhibitor allergy | Allergic Reaction Diuretics | Diuretic allergy | Allergic Reaction Pharmaceutical Preparations Containing Sulfa | Allergy to sulfonamides | Allergic Reaction Excipient Formulation | Hypersensitivity Excipient Formulation
Item
patients with allergic reactions or hypersensitivity to ace inhibitors, diuretics or medications containing sulfa and / or any excipients of formulation;
boolean
C1527304 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C0571939 (UMLS CUI [2])
C1527304 (UMLS CUI [3,1])
C0012798 (UMLS CUI [3,2])
C0571893 (UMLS CUI [4])
C1527304 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C0332256 (UMLS CUI [5,3])
C0749139 (UMLS CUI [5,4])
C0038757 (UMLS CUI [6])
C1527304 (UMLS CUI [7,1])
C0015237 (UMLS CUI [7,2])
C1705957 (UMLS CUI [7,3])
C0020517 (UMLS CUI [8,1])
C0015237 (UMLS CUI [8,2])
C1705957 (UMLS CUI [8,3])
Informed Consent Refused | Informed Consent Unable
Item
refusal or inability to provide the informed consent term.;
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Antihypertensive Agents Discontinue Refused
Item
refusal to discontinue the anti-hypertensive medication.
boolean
C0003364 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
Absence Indication Discontinue Pharmaceutical Preparations
Item
patients at the discretion of the investigator does not have indication for discontinuing the current medications;
boolean
C0332197 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
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