ID

32044

Beschrijving

Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

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  1. 15-10-18 15-10-18 -
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GlaxoSmithKline

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15 oktober 2018

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Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125

Engels

Vital Signs, ECG, Investigational Product, Pharmacodynamics Cortisol - Period 1; Day 1- 4

1 Formulieren  
Dosing date and time - Vital signs
Beschrijving

Dosing date and time - Vital signs

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing date and time
Beschrijving

Dosing date and time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Blood Pressure and Heart rate
Beschrijving

Blood Pressure and Heart rate

Alias
UMLS CUI-1
C0005823
UMLS CUI-2
C0018810
Actual time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Blood pressure (systolic/ diastolic)
Beschrijving

Blood Pressure

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Beschrijving

heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Dosing date and time - ECG
Beschrijving

Dosing date and time - ECG

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing date and time
Beschrijving

Dosing date and time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
12- Lead ECG
Beschrijving

12- Lead ECG

Alias
UMLS CUI-1
C0430456
Time of ECG
Beschrijving

Time of ECG

Datatype

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart rate
Beschrijving

heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beschrijving

Electrocardiogram: P-R interval

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschrijving

QRS complex duration (observable entity)

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beschrijving

QT interval - finding

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C1287082
msec
Method of QTc Calculation
Beschrijving

Electrocardiogram QT corrected interval; Evaluation Method

Datatype

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
If QTc interval was calculated mechanical, check method of caluclation
Beschrijving

Electrocardiogram QT corrected interval; Evaluation Method; Mechanical Methods

Datatype

text

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0443254
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
Beschrijving

QTcB - Bazett's Correction Formula; Mechanical Methods

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0443254
msec
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
Beschrijving

QTcF - Fridericia's Correction Formula; Mechanical Methods; Finding

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0443254
UMLS CUI [1,3]
C0243095
msec
If QTc interval was calcualted manually, check method of caluclation.
Beschrijving

Electrocardiogram QT corrected interval; Evaluation Method; Manual

Datatype

text

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0175674
If QTc interval was calculated manually with RR interval, enter finding.
Beschrijving

Electrocardiogram QT corrected interval; Manual; Finding

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C0175674
UMLS CUI [1,3]
C0243095
msec
Result of ECG
Beschrijving

EKG finding

Datatype

integer

Alias
UMLS CUI [1]
C0438154
Investigational Product
Beschrijving

Investigational Product

Alias
UMLS CUI-1
C0304229
Day 1 Ketoconazole - Start date/ time of dose
Beschrijving

Start date/ time of dose

Datatype

datetime

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C2983667
Day 1 Ketoconazole - Container Number
Beschrijving

Container Number

Datatype

text

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0180098
UMLS CUI [2,2]
C0237753
Day 1 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschrijving

Correct treatment during dosage interval

Datatype

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2349182
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C1272706
UMLS CUI [2,5]
C0347984
Day 1 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
Beschrijving

Reasons for wrong treatment

Datatype

text

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3827420
UMLS CUI [2,3]
C3146298
Day 2 Ketoconazole - Start date/ time of dose
Beschrijving

Start date/ time of dose

Datatype

datetime

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C2983667
Day 2 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschrijving

Correct treatment during dosage interval

Datatype

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2349182
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C1272706
UMLS CUI [2,5]
C0347984
Day 2 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
Beschrijving

Reasons for wrong treatment

Datatype

text

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3827420
UMLS CUI [2,3]
C3146298
Day 3 Ketoconazole - Start date/ time of dose
Beschrijving

Start date/ time of dose

Datatype

datetime

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C2983667
Day 3 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschrijving

Correct treatment during dosage interval

Datatype

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2349182
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C1272706
UMLS CUI [2,5]
C0347984
Day 3 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
Beschrijving

Reasons for wrong treatment

Datatype

text

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3827420
UMLS CUI [2,3]
C3146298
Day 4 Ketoconazole - Start date/ time of dose
Beschrijving

Start date/ time of dose

Datatype

datetime

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C2983667
Day 4 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschrijving

Correct treatment during dosage interval

Datatype

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2349182
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C1272706
UMLS CUI [2,5]
C0347984
Day 4 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
Beschrijving

Reasons for wrong treatment

Datatype

text

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3827420
UMLS CUI [2,3]
C3146298
Pharmacodynamics - Cortisol
Beschrijving

Pharmacodynamics - Cortisol

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0020268
Dosing date/ time
Beschrijving

Dosing date/ time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Date/ time of sample
Beschrijving

Date/ time of sample

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
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Similar models

Vital Signs, ECG, Investigational Product, Pharmacodynamics Cortisol - Period 1; Day 1- 4

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Dosing date and time - Vital signs
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Dosing date and time
Item
Dosing date and time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Blood Pressure and Heart rate
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Dosing date and time - ECG
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Dosing date and time
Item
Dosing date and time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
12- Lead ECG
C0430456 (UMLS CUI-1)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Electrocardiogram QT corrected interval; Evaluation Method
Code List
Method of QTc Calculation
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanical, check method of caluclation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
undefined item
Code List
If QTc interval was calculated mechanical, check method of caluclation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTcB - Bazett's Correction Formula; Mechanical Methods
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
QTcF - Fridericia's Correction Formula; Mechanical Methods; Finding
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
undefined item
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
Electrocardiogram QT corrected interval; Manual; Finding
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
Result of ECG
integer
C0438154 (UMLS CUI [1])
EKG finding
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Start date/ time of dose
Item
Day 1 Ketoconazole - Start date/ time of dose
datetime
C0022625 (UMLS CUI [1,1])
C2983667 (UMLS CUI [1,2])
Container Number
Item
Day 1 Ketoconazole - Container Number
text
C0022625 (UMLS CUI [1])
C0180098 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Correct treatment during dosage interval
Item
Day 1 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
Reasons for wrong treatment
Item
Day 1 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
text
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Start date/ time of dose
Item
Day 2 Ketoconazole - Start date/ time of dose
datetime
C0022625 (UMLS CUI [1,1])
C2983667 (UMLS CUI [1,2])
Correct treatment during dosage interval
Item
Day 2 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
Reasons for wrong treatment
Item
Day 2 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
text
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Start date/ time of dose
Item
Day 3 Ketoconazole - Start date/ time of dose
datetime
C0022625 (UMLS CUI [1,1])
C2983667 (UMLS CUI [1,2])
Correct treatment during dosage interval
Item
Day 3 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
Reasons for wrong treatment
Item
Day 3 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
text
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Start date/ time of dose
Item
Day 4 Ketoconazole - Start date/ time of dose
datetime
C0022625 (UMLS CUI [1,1])
C2983667 (UMLS CUI [1,2])
Correct treatment during dosage interval
Item
Day 4 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
Reasons for wrong treatment
Item
Day 4 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
text
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Item Group
Pharmacodynamics - Cortisol
C0851347 (UMLS CUI-1)
C0020268 (UMLS CUI-2)
Dosing date/ time
Item
Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Date/ time of sample
Item
Date/ time of sample
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
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