ID

32893

Description

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

Mots-clés

Versions (1)
  1. 19/11/2018 19/11/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

19 novembre 2018

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Completion Period: Vital Signs

1 Formulaires  
Administrative data
Description

Administrative data

Study Name
Description

Study Name

Type de données

text

Site
Description

Site

Type de données

text

Subject
Description

Subject

Type de données

text

Visit Name
Description

Visit Name

Type de données

text

DCI Name/Shortname
Description

DCI Name/Shortname

Type de données

text

Status
Description

Status

Type de données

text

Doc#
Description

Doc#

Type de données

integer

Visit #
Description

Visit #

Type de données

float

Study Completion
Description

Study Completion

Date of Final Contact
Description

Date of Final Contact

Type de données

date

Date of Last Dose
Description

Date of Last Dose

Type de données

date

Did subject complete the study?
Description

Did subject complete the study?

Type de données

boolean

If NO, mark one reason
Description

If NO, mark one reason

Type de données

text

Date of Discontinuation
Description

Date of Discontinuation

Type de données

date

Comments
Description

Comments

Type de données

text

If Liver chemistry stopping criteria, specify Adverse Event Number
Description

If Liver chemistry stopping criteria, specify Adverse Event Number

Type de données

integer

If Adverse Event, specify Adverse Event Number
Description

If Adverse Event, specify Adverse Event Number

Type de données

integer

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

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

Type de données

integer

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

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

Type de données

integer

If QT interval withdrawal criteria, specify Adverse Event Number
Description

If QT interval withdrawal criteria, specify Adverse Event Number

Type de données

integer

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

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

Type de données

integer

Double-Blind Method
Description

Double-Blind Method

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

Was the blind broken for this subjects during the study?

Type de données

boolean

If Yes, date of unblinding
Description

If Yes, date of unblinding

Type de données

date

Time of unblinding
Description

Time of unblinding

Type de données

time

Reason
Description

Reason

Type de données

text

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Similar models

Completion Period: Vital Signs

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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