ID

32893

Descripción

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

Palabras clave

Versiones (1)
  1. 19/11/18 19/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

19 de noviembre de 2018

DOI

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Licencia

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

Inglés

Completion Period: Vital Signs

1 formularios  
Administrative data
Descripción

Administrative data

Study Name
Descripción

Study Name

Tipo de datos

text

Site
Descripción

Site

Tipo de datos

text

Subject
Descripción

Subject

Tipo de datos

text

Visit Name
Descripción

Visit Name

Tipo de datos

text

DCI Name/Shortname
Descripción

DCI Name/Shortname

Tipo de datos

text

Status
Descripción

Status

Tipo de datos

text

Doc#
Descripción

Doc#

Tipo de datos

integer

Visit #
Descripción

Visit #

Tipo de datos

float

Study Completion
Descripción

Study Completion

Date of Final Contact
Descripción

Date of Final Contact

Tipo de datos

date

Date of Last Dose
Descripción

Date of Last Dose

Tipo de datos

date

Did subject complete the study?
Descripción

Did subject complete the study?

Tipo de datos

boolean

If NO, mark one reason
Descripción

If NO, mark one reason

Tipo de datos

text

Date of Discontinuation
Descripción

Date of Discontinuation

Tipo de datos

date

Comments
Descripción

Comments

Tipo de datos

text

If Liver chemistry stopping criteria, specify Adverse Event Number
Descripción

If Liver chemistry stopping criteria, specify Adverse Event Number

Tipo de datos

integer

If Adverse Event, specify Adverse Event Number
Descripción

If Adverse Event, specify Adverse Event Number

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

If QT interval withdrawal criteria, specify Adverse Event Number
Descripción

If QT interval withdrawal criteria, specify Adverse Event Number

Tipo de datos

integer

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

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

Tipo de datos

integer

Double-Blind Method
Descripción

Double-Blind Method

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

Was the blind broken for this subjects during the study?

Tipo de datos

boolean

If Yes, date of unblinding
Descripción

If Yes, date of unblinding

Tipo de datos

date

Time of unblinding
Descripción

Time of unblinding

Tipo de datos

time

Reason
Descripción

Reason

Tipo de datos

text

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Similar models

Completion Period: Vital Signs

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
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