ID

32140

Beschreibung

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

Stichworte

Versionen (1)
  1. 21.10.18 21.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

21. Oktober 2018

DOI

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Creative Commons BY-NC 3.0
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Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125

Englisch

Status of Treatment Blind, Vital Signs, ECG, Study Conclusion, Pregnancy Information, Electronically Transferred Lab Data - Follow- Up

1 Formulare  
Status of Treatment blind
Beschreibung

Status of Treatment blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during study? If yes, complete the Adverse Event form and/ or Investigational Product forms as appropriate.
Beschreibung

Treatment blind broken during study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C1709750
If the treatment blind was broken during the study, record date and time of blind broken.
Beschreibung

Date and time of blind broken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C1709750
UMLS CUI [1,4]
C1264639
If the Treatment blind was broken during the study, record reason.
Beschreibung

Reason for blind broken

Datentyp

integer

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C1709750
UMLS CUI [1,4]
C0566251
Other reason blind broken
Beschreibung

Other reason blind broken

Datentyp

text

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C1709750
UMLS CUI [1,4]
C0566251
UMLS CUI [1,5]
C0205394
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
Actual time
Beschreibung

Actual Time

Datentyp

time

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

Blood Pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Beschreibung

heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12- Lead ECG
Beschreibung

12- Lead ECG

Alias
UMLS CUI-1
C0430456
Time of ECG
Beschreibung

Time of ECG

Datentyp

time

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

heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beschreibung

Electrocardiogram: P-R interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschreibung

QRS complex duration (observable entity)

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beschreibung

QT interval - finding

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C1287082
msec
Method of QTc Calculation
Beschreibung

Electrocardiogram QT corrected interval; Evaluation Method

Datentyp

integer

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

Electrocardiogram QT corrected interval; Evaluation Method; Mechanical Methods

Datentyp

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.
Beschreibung

QTcB - Bazett's Correction Formula; Mechanical Methods

Datentyp

float

Maßeinheiten
  • 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.
Beschreibung

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

Datentyp

float

Maßeinheiten
  • 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.
Beschreibung

Electrocardiogram QT corrected interval; Evaluation Method; Manual

Datentyp

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.
Beschreibung

Electrocardiogram QT corrected interval; Manual; Finding

Datentyp

float

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

EKG finding

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C2603343
Date of last contact
Beschreibung

If the subject completed the study, date of last contact must match the last actual contact with the subject wether or not the contact was a clinic visit.

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Beschreibung

Was the subject withdrawn from the study

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
If subject was withdrawn from study, record date of decision to withdraw.
Beschreibung

Date of decision to withdraw

Datentyp

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
If subjects was withdrawn from study, check reason for withdrawal.
Beschreibung

Reason for withdrawal

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3146298
Case book ready for signature
Beschreibung

Case book ready for signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Pregnancy Information
Beschreibung

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschreibung

If yes, complete the paper Pregnancy Notification form.

Datentyp

boolean

Did a female partner of the male subject become pregnant during the study?
Beschreibung

If yes, complete the paper Pregnncy Notification form.

Datentyp

text

Electronically transferred lab data
Beschreibung

Electronically transferred lab data

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1320722
Hematology Date and time sample taken
Beschreibung

Hematology Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0018943
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Clinical Chemistry Date and time sample taken
Beschreibung

Clinical Chemistry Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis Date and time sample taken
Beschreibung

Urinalysis Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
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Ähnliche Modelle

Status of Treatment Blind, Vital Signs, ECG, Study Conclusion, Pregnancy Information, Electronically Transferred Lab Data - Follow- Up

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Status of Treatment blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Treatment blind broken during study
Item
Was the treatment blind broken during study? If yes, complete the Adverse Event form and/ or Investigational Product forms as appropriate.
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C1709750 (UMLS CUI [1,3])
Date and time of blind broken
Item
If the treatment blind was broken during the study, record date and time of blind broken.
datetime
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C1709750 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,4])
Item
If the Treatment blind was broken during the study, record reason.
integer
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C1709750 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Reason for blind broken
Code List
If the Treatment blind was broken during the study, record reason.
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
Other reason blind broken
Item
Other reason blind broken
text
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C1709750 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
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
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
Study Conclusion
C1707478 (UMLS CUI-1)
C2603343 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the subject withdrawn from the study
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Date of decision to withdraw
Item
If subject was withdrawn from study, record date of decision to withdraw.
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If subjects was withdrawn from study, check reason for withdrawal.
integer
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Reason for withdrawal
Code List
If subjects was withdrawn from study, check reason for withdrawal.
CL Item
Adverse Event (Record details on the Non- Serious Adverse Events or Serious Adverse Events forms as appropriate) (1)
CL Item
Protocol deviation (3)
CL Item
Study closed/ terminated (5)
CL Item
Lost to Follow- up (6)
CL Item
Withdrew consent (8)
Item
Case book ready for signature
text
C1519316 (UMLS CUI [1])
Case book ready for signature
Code List
Case book ready for signature
CL Item
Yes (Y)
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
Item
Did a female partner of the male subject become pregnant during the study?
text
Did a female partner of the male subject become pregnant during the study?
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (Check Not Applicable if female partner not of childbearing potential or no female partner) (X)
Item Group
Electronically transferred lab data
C0022885 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
Hematology Date and time sample taken
Item
Hematology Date and time sample taken
datetime
C0018943 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
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