ID

34712

Beskrivning

Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532; ODM derived from: https://clinicaltrials.gov/show/NCT01369602

Länk

https://clinicaltrials.gov/show/NCT01369602

Nyckelord

Versioner (1)
  1. 2019-01-24 2019-01-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 januari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01369602

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT01369602

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
stable renal function defined as <20% difference between two measurements of serum creatinine obtained on two occasions separated by at least 72 hours to 14 days; the second determination must be obtained within the 28-day period prior to the start of study medication administration. crcl value at screening (average of two values obtained within two weeks apart before dosing) will be used for study enrollment.
Beskrivning

Renal function Stable | Serum creatinine measurement Quantity | Difference Measurements Percentage | Creatinine clearance measurement Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0201976
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1705242
UMLS CUI [3,2]
C0242485
UMLS CUI [3,3]
C0439165
UMLS CUI [4,1]
C0373595
UMLS CUI [4,2]
C1265611
body mass index (bmi) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lbs).
Beskrivning

Body mass index | Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable | Hormonal contraception Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1299582
UMLS CUI [5,1]
C2985296
UMLS CUI [5,2]
C0332196
subjects with recent (within the last 6 months) history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack (tia).
Beskrivning

Myocardial Infarction | Angina, Unstable | Coronary revascularisation | Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0877341
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0007787
subjects with severe heart failure (new york heart association functional class iv) at screening.
Beskrivning

Heart failure Severe New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1275491
subjects with acute renal disease.
Beskrivning

Kidney Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0022658
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01369602

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Renal function Stable | Serum creatinine measurement Quantity | Difference Measurements Percentage | Creatinine clearance measurement Quantity
Item
stable renal function defined as <20% difference between two measurements of serum creatinine obtained on two occasions separated by at least 72 hours to 14 days; the second determination must be obtained within the 28-day period prior to the start of study medication administration. crcl value at screening (average of two values obtained within two weeks apart before dosing) will be used for study enrollment.
boolean
C0232804 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1705242 (UMLS CUI [3,1])
C0242485 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
C0373595 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Body mass index | Body Weight
Item
body mass index (bmi) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lbs).
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Protocol Compliance
Item
subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable | Hormonal contraception Excluded
Item
pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
C2985296 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
Myocardial Infarction | Angina, Unstable | Coronary revascularisation | Cerebrovascular accident | Transient Ischemic Attack
Item
subjects with recent (within the last 6 months) history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack (tia).
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0877341 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
Heart failure Severe New York Heart Association Classification
Item
subjects with severe heart failure (new york heart association functional class iv) at screening.
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Kidney Disease
Item
subjects with acute renal disease.
boolean
C0022658 (UMLS CUI [1])
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