ID

36107

Beschreibung

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

Stichworte

Versionen (1)
  1. 15.04.19 15.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

15. April 2019

DOI

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Eligibility Hypertension NCT01620788

Englisch

Eligibility Hypertension NCT01620788

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Adult | Age

Datentyp

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,
Beschreibung

Therapy Hypertensive disease | Sitting blood pressure Measurement Quantity

Datentyp

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,
Beschreibung

Normal Laboratory Test Result

Datentyp

boolean

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

Prior Therapy Hypertensive disease To be stopped

Datentyp

boolean

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

Exclusion Criteria

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

Blood pressure determination

Datentyp

boolean

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

Uncontrolled hypertension | Thiazide Diuretics

Datentyp

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);
Beschreibung

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

Datentyp

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);
Beschreibung

Hypokalemia | Hyperkalemia | Serum potassium abnormal

Datentyp

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;
Beschreibung

Alanine aminotransferase increased | Liver disease

Datentyp

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;
Beschreibung

Pregnancy | Childbearing Potential Contraceptive methods Absent | Pregnancy, Planned

Datentyp

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;
Beschreibung

Substance Use Disorders

Datentyp

boolean

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

Secondary hypertension | Renal vascular disorder | Pheochromocytoma | Cushing Syndrome

Datentyp

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;
Beschreibung

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

Datentyp

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.;
Beschreibung

Informed Consent Refused | Informed Consent Unable

Datentyp

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.
Beschreibung

Antihypertensive Agents Discontinue Refused

Datentyp

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;
Beschreibung

Absence Indication Discontinue Pharmaceutical Preparations

Datentyp

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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Ähnliche Modelle

Eligibility Hypertension NCT01620788

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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