ID

32893

Beskrivning

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Nyckelord

Versioner (1)
  1. 2018-11-19 2018-11-19 -
Rättsinnehavare

GSK group of companies

Uppladdad den

19 november 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

Engelsk

Completion Period: Vital Signs

1 Formulär  
Administrative data
Beskrivning

Administrative data

Study Name
Beskrivning

Study Name

Datatyp

text

Site
Beskrivning

Site

Datatyp

text

Subject
Beskrivning

Subject

Datatyp

text

Visit Name
Beskrivning

Visit Name

Datatyp

text

DCI Name/Shortname
Beskrivning

DCI Name/Shortname

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Doc#
Beskrivning

Doc#

Datatyp

integer

Visit #
Beskrivning

Visit #

Datatyp

float

Study Completion
Beskrivning

Study Completion

Date of Final Contact
Beskrivning

Date of Final Contact

Datatyp

date

Date of Last Dose
Beskrivning

Date of Last Dose

Datatyp

date

Did subject complete the study?
Beskrivning

Did subject complete the study?

Datatyp

boolean

If NO, mark one reason
Beskrivning

If NO, mark one reason

Datatyp

text

Date of Discontinuation
Beskrivning

Date of Discontinuation

Datatyp

date

Comments
Beskrivning

Comments

Datatyp

text

If Liver chemistry stopping criteria, specify Adverse Event Number
Beskrivning

If Liver chemistry stopping criteria, specify Adverse Event Number

Datatyp

integer

If Adverse Event, specify Adverse Event Number
Beskrivning

If Adverse Event, specify Adverse Event Number

Datatyp

integer

If Severe or repeated occurrences of hypoglycemia, specify Adverse Event Number
Beskrivning

If Severe or repeated occurrences of hypoglycemia, specify Adverse Event Number

Datatyp

integer

If Pancreatitis or skin and systematic allergic reactions, specify Adverse Event Number
Beskrivning

If Pancreatitis or skin and systematic allergic reactions, specify Adverse Event Number

Datatyp

integer

If QT interval withdrawal criteria, specify Adverse Event Number
Beskrivning

If QT interval withdrawal criteria, specify Adverse Event Number

Datatyp

integer

If Nausea requiring the use of antiemetics, specify Adverse Event Number
Beskrivning

If Nausea requiring the use of antiemetics, specify Adverse Event Number

Datatyp

integer

Double-Blind Method
Beskrivning

Double-Blind Method

Was the blind broken for this subjects during the study?
Beskrivning

Was the blind broken for this subjects during the study?

Datatyp

boolean

If Yes, date of unblinding
Beskrivning

If Yes, date of unblinding

Datatyp

date

Time of unblinding
Beskrivning

Time of unblinding

Datatyp

time

Reason
Beskrivning

Reason

Datatyp

text

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Similar models

Completion Period: Vital Signs

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Study Name
Item
Study Name
text
Site
Item
Site
text
Subject
Item
Subject
text
Visit Name
Item
Visit Name
text
DCI Name/Shortname
Item
DCI Name/Shortname
text
Status
Item
Status
text
Doc#
Item
Doc#
integer
Visit #
Item
Visit #
float
Item Group
Study Completion
Date of Final Contact
Item
Date of Final Contact
date
Date of Last Dose
Item
Date of Last Dose
date
Did subject complete the study?
Item
Did subject complete the study?
boolean
Item
If NO, mark one reason
text
If NO, mark one reason
Code List
If NO, mark one reason
CL Item
Liver chemistry stopping criteria (1)
CL Item
Adverse Event (2)
CL Item
Severe or repeated occurrences of hypoglycemia (3)
CL Item
Pancreatitis or skin and systematic allergic reactions (4)
CL Item
QT interval withdrawal criteria  (5)
CL Item
Consent withdrawn  (6)
CL Item
Lost to Follow-Up (7)
CL Item
Protocol violation (8)
CL Item
Noncompliance with study visit schedule (9)
CL Item
Termination of study by sponsor (10)
CL Item
Pregnancy (11)
CL Item
Nausea requiring the use of antiemetics  (12)
CL Item
Other (specify in comments) (13)
Date of Discontinuation
Item
Date of Discontinuation
date
Comments
Item
Comments
text
If Liver chemistry stopping criteria, specify Adverse Event Number
Item
If Liver chemistry stopping criteria, specify Adverse Event Number
integer
If Adverse Event, specify Adverse Event Number
Item
If Adverse Event, specify Adverse Event Number
integer
If Severe or repeated occurrences of hypoglycemia, specify Adverse Event Number
Item
If Severe or repeated occurrences of hypoglycemia, specify Adverse Event Number
integer
If Pancreatitis or skin and systematic allergic reactions, specify Adverse Event Number
Item
If Pancreatitis or skin and systematic allergic reactions, specify Adverse Event Number
integer
If QT interval withdrawal criteria, specify Adverse Event Number
Item
If QT interval withdrawal criteria, specify Adverse Event Number
integer
If Nausea requiring the use of antiemetics, specify Adverse Event Number
Item
If Nausea requiring the use of antiemetics, specify Adverse Event Number
integer
Item Group
Double-Blind Method
Was the blind broken for this subjects during the study?
Item
Was the blind broken for this subjects during the study?
boolean
If Yes, date of unblinding
Item
If Yes, date of unblinding
date
Time of unblinding
Item
Time of unblinding
time
Reason
Item
Reason
text
Tillbaka till toppen 

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