ID

39169

Beschreibung

Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01435174

Link

https://clinicaltrials.gov/show/NCT01435174

Stichworte

Versionen (2)
  1. 07.12.19 07.12.19 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Dezember 2019

DOI

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Eligibility End-stage Renal Disease NCT01435174

Englisch

Eligibility End-stage Renal Disease NCT01435174

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
18-74 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
within 50% of ideal body weight and greater than 40 kg
Beschreibung

Ideal Body Weight Percentage | Body Weight

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0421272
UMLS CUI [1,2]
C0439165
UMLS CUI [2]
C0005910
chronic kidney disease (ckd) stage 5 receiving maintenance hemodialysis for at least 3 months
Beschreibung

Chronic kidney disease stage | Maintenance hemodialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C2074731
UMLS CUI [2]
C4040576
native kidney estimated glomerular filtration rate(gfr) < 10 ml/min
Beschreibung

Kidney Native | Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022646
UMLS CUI [1,2]
C0302891
UMLS CUI [2]
C3811844
no concurrent illness or evidence of infection
Beschreibung

Comorbidity Absent | Communicable Disease Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0332197
able to give informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
qtc interval > 470 msec at echocardiogram (ecg) obtained within the last 6 months
Beschreibung

Prolonged QTc interval Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1560305
UMLS CUI [1,2]
C0013516
concomitant qt-prolonging drugs, major p-gp inhibitors, and cyp3a4 inducers and inhibitors including: cyclosporine, rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, st. john's wort, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir, quinidine, dofetilide, sotalol, amiodarone, erythromycin, thioridazine, ziprasidone, haloperidol, trimethoprim/sulfamethoxazole, ciprofloxacin, norfloxacin, levofloxacin, moxifloxacin
Beschreibung

Pharmaceutical Preparations Causing Prolonged QT interval | P-Glycoprotein Inhibitors Major | CYP3A4 Inducers | CYP3A4 Inhibitors | Cyclosporine | Rifampin | Rifabutin | rifapentine | Phenobarbital | Phenytoin | Carbamazepine | ST. JOHN'S WORT EXTRACT | Ketoconazole | Itraconazole | Clarithromycin | nefazodone | Nelfinavir | Ritonavir | Indinavir | Saquinavir | Quinidine | dofetilide | Sotalol | Amiodarone | Erythromycin | Thioridazine | ziprasidone | Haloperidol | Trimethoprim | Sulfamethoxazole | Ciprofloxacin | Norfloxacin | Levofloxacin | moxifloxacin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C3500483
UMLS CUI [2,2]
C0205164
UMLS CUI [3]
C3850041
UMLS CUI [4]
C3850053
UMLS CUI [5]
C0010592
UMLS CUI [6]
C0035608
UMLS CUI [7]
C0140575
UMLS CUI [8]
C0073372
UMLS CUI [9]
C0031412
UMLS CUI [10]
C0031507
UMLS CUI [11]
C0006949
UMLS CUI [12]
C0813171
UMLS CUI [13]
C0022625
UMLS CUI [14]
C0064113
UMLS CUI [15]
C0055856
UMLS CUI [16]
C0068485
UMLS CUI [17]
C0525005
UMLS CUI [18]
C0292818
UMLS CUI [19]
C0376637
UMLS CUI [20]
C0286738
UMLS CUI [21]
C0034414
UMLS CUI [22]
C0114771
UMLS CUI [23]
C0037707
UMLS CUI [24]
C0002598
UMLS CUI [25]
C0014806
UMLS CUI [26]
C0039943
UMLS CUI [27]
C0380393
UMLS CUI [28]
C0018546
UMLS CUI [29]
C0041041
UMLS CUI [30]
C0038689
UMLS CUI [31]
C0008809
UMLS CUI [32]
C0028365
UMLS CUI [33]
C0282386
UMLS CUI [34]
C0536495
pre-study hemoglobin < 9.5 g/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
plasma albumin < 2.5 g/dl
Beschreibung

Plasma albumin level

Datentyp

boolean

Alias
UMLS CUI [1]
C1272106
liver disease - exclude subjects with a child pugh score of c or higher
Beschreibung

Liver disease Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C2347612
positive pregnancy test
Beschreibung

Pregnancy test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0240802
breastfeeding
Beschreibung

Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
allergy to ranolazine
Beschreibung

Hypersensitivity Ranolazine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0073633
participating in another investigational study
Beschreibung

Study Subject Participation Status | Clinical Research

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008972
hepatitis b infection due to dialysis isolation requirements
Beschreibung

Hepatitis B | Etiology Dialysis Isolation procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0011946
UMLS CUI [2,3]
C0204727
unstable blood pressure control
Beschreibung

Control of blood pressure Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1753303
UMLS CUI [1,2]
C0443343
need for routine large fluid removal during dialysis (> 4l)
Beschreibung

Removal Fluid Large | Dialysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1883720
UMLS CUI [1,2]
C0005889
UMLS CUI [1,3]
C0549177
UMLS CUI [2]
C0011946
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility End-stage Renal Disease NCT01435174

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18-74 years of age
boolean
C0001779 (UMLS CUI [1])
Ideal Body Weight Percentage | Body Weight
Item
within 50% of ideal body weight and greater than 40 kg
boolean
C0421272 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2])
Chronic kidney disease stage | Maintenance hemodialysis
Item
chronic kidney disease (ckd) stage 5 receiving maintenance hemodialysis for at least 3 months
boolean
C2074731 (UMLS CUI [1])
C4040576 (UMLS CUI [2])
Kidney Native | Estimated Glomerular Filtration Rate
Item
native kidney estimated glomerular filtration rate(gfr) < 10 ml/min
boolean
C0022646 (UMLS CUI [1,1])
C0302891 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Comorbidity Absent | Communicable Disease Absent
Item
no concurrent illness or evidence of infection
boolean
C0009488 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prolonged QTc interval Echocardiography
Item
qtc interval > 470 msec at echocardiogram (ecg) obtained within the last 6 months
boolean
C1560305 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Pharmaceutical Preparations Causing Prolonged QT interval | P-Glycoprotein Inhibitors Major | CYP3A4 Inducers | CYP3A4 Inhibitors | Cyclosporine | Rifampin | Rifabutin | rifapentine | Phenobarbital | Phenytoin | Carbamazepine | ST. JOHN'S WORT EXTRACT | Ketoconazole | Itraconazole | Clarithromycin | nefazodone | Nelfinavir | Ritonavir | Indinavir | Saquinavir | Quinidine | dofetilide | Sotalol | Amiodarone | Erythromycin | Thioridazine | ziprasidone | Haloperidol | Trimethoprim | Sulfamethoxazole | Ciprofloxacin | Norfloxacin | Levofloxacin | moxifloxacin
Item
concomitant qt-prolonging drugs, major p-gp inhibitors, and cyp3a4 inducers and inhibitors including: cyclosporine, rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, st. john's wort, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir, quinidine, dofetilide, sotalol, amiodarone, erythromycin, thioridazine, ziprasidone, haloperidol, trimethoprim/sulfamethoxazole, ciprofloxacin, norfloxacin, levofloxacin, moxifloxacin
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C3500483 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C3850041 (UMLS CUI [3])
C3850053 (UMLS CUI [4])
C0010592 (UMLS CUI [5])
C0035608 (UMLS CUI [6])
C0140575 (UMLS CUI [7])
C0073372 (UMLS CUI [8])
C0031412 (UMLS CUI [9])
C0031507 (UMLS CUI [10])
C0006949 (UMLS CUI [11])
C0813171 (UMLS CUI [12])
C0022625 (UMLS CUI [13])
C0064113 (UMLS CUI [14])
C0055856 (UMLS CUI [15])
C0068485 (UMLS CUI [16])
C0525005 (UMLS CUI [17])
C0292818 (UMLS CUI [18])
C0376637 (UMLS CUI [19])
C0286738 (UMLS CUI [20])
C0034414 (UMLS CUI [21])
C0114771 (UMLS CUI [22])
C0037707 (UMLS CUI [23])
C0002598 (UMLS CUI [24])
C0014806 (UMLS CUI [25])
C0039943 (UMLS CUI [26])
C0380393 (UMLS CUI [27])
C0018546 (UMLS CUI [28])
C0041041 (UMLS CUI [29])
C0038689 (UMLS CUI [30])
C0008809 (UMLS CUI [31])
C0028365 (UMLS CUI [32])
C0282386 (UMLS CUI [33])
C0536495 (UMLS CUI [34])
Hemoglobin measurement
Item
pre-study hemoglobin < 9.5 g/dl
boolean
C0518015 (UMLS CUI [1])
Plasma albumin level
Item
plasma albumin < 2.5 g/dl
boolean
C1272106 (UMLS CUI [1])
Liver disease Child-Pugh Classification
Item
liver disease - exclude subjects with a child pugh score of c or higher
boolean
C0023895 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Pregnancy test positive
Item
positive pregnancy test
boolean
C0240802 (UMLS CUI [1])
Breast Feeding
Item
breastfeeding
boolean
C0006147 (UMLS CUI [1])
Hypersensitivity Ranolazine
Item
allergy to ranolazine
boolean
C0020517 (UMLS CUI [1,1])
C0073633 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Research
Item
participating in another investigational study
boolean
C2348568 (UMLS CUI [1])
C0008972 (UMLS CUI [2])
Hepatitis B | Etiology Dialysis Isolation procedure
Item
hepatitis b infection due to dialysis isolation requirements
boolean
C0019163 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0011946 (UMLS CUI [2,2])
C0204727 (UMLS CUI [2,3])
Control of blood pressure Unstable
Item
unstable blood pressure control
boolean
C1753303 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Removal Fluid Large | Dialysis
Item
need for routine large fluid removal during dialysis (> 4l)
boolean
C1883720 (UMLS CUI [1,1])
C0005889 (UMLS CUI [1,2])
C0549177 (UMLS CUI [1,3])
C0011946 (UMLS CUI [2])
Zum Seitenanfang zurückkehren 

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