ID

32016

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. 12.10.18 12.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

12. 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

Vital Signs and ECG - Screening

1 Formulare  
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/ time
Beschreibung

Date/Time

Datentyp

datetime

Alias
UMLS CUI [1]
C1264639
Height
Beschreibung

Body Height

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Beschreibung

Body mass index

Datentyp

float

Alias
UMLS CUI [1]
C1305855
Blood Pressure and Heart rate
Beschreibung

Blood Pressure and Heart rate

Alias
UMLS CUI-1
C0005823
UMLS CUI-2
C0018810
Actual date/ time
Beschreibung

Date/Time

Datentyp

datetime

Alias
UMLS CUI [1]
C1264639
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
Date and Time of ECG
Beschreibung

Electrocardiogram Collection Date Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826846
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
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Ähnliche Modelle

Vital Signs and ECG - Screening

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date/Time
Item
Actual date/ time
datetime
C1264639 (UMLS CUI [1])
Body Height
Item
Height
float
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
Date/Time
Item
Actual date/ time
datetime
C1264639 (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)
Electrocardiogram Collection Date Time
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
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)
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