ID

19817

Beschreibung

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Stichworte

Versionen (2)
  1. 12.12.16 12.12.16 -
  2. 28.01.17 28.01.17 -
Hochgeladen am

28. Januar 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Visit 5 PK - Blood Sample for ASP1941 and Metformin [PC_2] NCT01117584

Englisch

Visit 5 PK - Blood Sample for ASP1941 and Metformin [PC_2] NCT01117584

1 Formulare  
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263
Specimen Material Type: Plasma
Beschreibung

Specimen Material Type

Datentyp

boolean

Alias
UMLS CUI [1]
C1609077
Date of Dose of ASP1941 (Tablets) On Day Of Sampling
Beschreibung

Date of Dose of ASP1941

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0005834
Time of Dose of ASP1941 (Tablets) On Day Of Sampling
Beschreibung

Time of Dose of ASP1941

Datentyp

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0005834
Date of Dose of Metformin On Day of Sampling
Beschreibung

Date of Dose of Metformin

Datentyp

date

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0005834
Time of 1st Dose of Metformin On Day of Sampling
Beschreibung

Time of 1st Dose of Metformin On Day of Sampling

Datentyp

time

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C0439228
UMLS CUI [1,5]
C0005834
Dose of Metformin
Beschreibung

Dose of Metformin

Datentyp

text

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205435
Time of 2nd Dose of Metformin On Day of Sampling
Beschreibung

Time of 2nd Dose of Metformin On Day of Sampling

Datentyp

time

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0205436
UMLS CUI [1,4]
C0439228
UMLS CUI [1,5]
C0005834
Dose of 2nd Metfomin
Beschreibung

Dose of 2nd Metfomin

Datentyp

text

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205436
Time of 3rd Dose of Metformin On Day Of Sampling
Beschreibung

Time of 3rd Dose of Metformin On Day Of Sampling

Datentyp

time

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0205437
UMLS CUI [1,4]
C0439228
UMLS CUI [1,5]
C0005834
Dose (3rd) of Metformin
Beschreibung

Dose of 3rd Metformin

Datentyp

text

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205437
Time of 4th Dose of Metformin On Day Of Sampling
Beschreibung

Time of 4th Dose of Metformin On Day Of Sampling

Datentyp

time

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0205438
UMLS CUI [1,4]
C0439228
UMLS CUI [1,5]
C0005834
Dose of 4th Metformin
Beschreibung

Dose of 4th Metformin

Datentyp

text

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205438
Date of Dose of ASP1941 (Tablets) on day before Sampling
Beschreibung

Date of Dose of ASP1941 (Tablets) on day before Sampling

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0005834
Time of Dose of ASP1941 (Tablets) on day before Sampling
Beschreibung

Time of Dose of ASP1941 (Tablets) on day before Sampling

Datentyp

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0005834
Date of Dose of Metformin on day before Sampling
Beschreibung

Date of Dose of Metformin on day before Sampling

Datentyp

date

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0005834
Time of last Dose of Metformin on Day before Sampling
Beschreibung

Time of last Dose of Metformin on Day before Sampling

Datentyp

time

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C0439228
UMLS CUI [1,5]
C0332152
UMLS CUI [1,6]
C0005834
Dose of last time Metformin
Beschreibung

Dose of last time Metformin

Datentyp

text

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1517741
Scheduled time
Beschreibung

Scheduled time

Datentyp

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Not Done (Check if sample Not Drawn or Not Sent to Lab)
Beschreibung

Not Done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1272696
Requisition Number
Beschreibung

Requisition Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0237753
Date of Sample Taken
Beschreibung

Date of Sample Taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Actual Sample Time
Beschreibung

Actual Sample Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
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Ähnliche Modelle

Visit 5 PK - Blood Sample for ASP1941 and Metformin [PC_2] NCT01117584

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Specimen Material Type
Item
Specimen Material Type: Plasma
boolean
C1609077 (UMLS CUI [1])
Date of Dose of ASP1941
Item
Date of Dose of ASP1941 (Tablets) On Day Of Sampling
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
Time of Dose of ASP1941
Item
Time of Dose of ASP1941 (Tablets) On Day Of Sampling
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
Date of Dose of Metformin
Item
Date of Dose of Metformin On Day of Sampling
date
C0025598 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
Time of 1st Dose of Metformin On Day of Sampling
Item
Time of 1st Dose of Metformin On Day of Sampling
time
C0025598 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,4])
C0005834 (UMLS CUI [1,5])
Dose of Metformin
Item
Dose of Metformin
text
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
Time of 2nd Dose of Metformin On Day of Sampling
Item
Time of 2nd Dose of Metformin On Day of Sampling
time
C0025598 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,4])
C0005834 (UMLS CUI [1,5])
Dose of 2nd Metfomin
Item
Dose of 2nd Metfomin
text
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
Time of 3rd Dose of Metformin On Day Of Sampling
Item
Time of 3rd Dose of Metformin On Day Of Sampling
time
C0025598 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0205437 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,4])
C0005834 (UMLS CUI [1,5])
Dose of 3rd Metformin
Item
Dose (3rd) of Metformin
text
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205437 (UMLS CUI [1,3])
Time of 4th Dose of Metformin On Day Of Sampling
Item
Time of 4th Dose of Metformin On Day Of Sampling
time
C0025598 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0205438 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,4])
C0005834 (UMLS CUI [1,5])
Dose of 4th Metformin
Item
Dose of 4th Metformin
text
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205438 (UMLS CUI [1,3])
Date of Dose of ASP1941 (Tablets) on day before Sampling
Item
Date of Dose of ASP1941 (Tablets) on day before Sampling
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0005834 (UMLS CUI [1,5])
Time of Dose of ASP1941 (Tablets) on day before Sampling
Item
Time of Dose of ASP1941 (Tablets) on day before Sampling
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0005834 (UMLS CUI [1,5])
Date of Dose of Metformin on day before Sampling
Item
Date of Dose of Metformin on day before Sampling
date
C0025598 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0005834 (UMLS CUI [1,5])
Time of last Dose of Metformin on Day before Sampling
Item
Time of last Dose of Metformin on Day before Sampling
time
C0025598 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,4])
C0332152 (UMLS CUI [1,5])
C0005834 (UMLS CUI [1,6])
Dose of last time Metformin
Item
Dose of last time Metformin
text
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Scheduled time
Item
Scheduled time
text
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Not Done
Item
Not Done (Check if sample Not Drawn or Not Sent to Lab)
boolean
C0005834 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Requisition Number
Item
Requisition Number
integer
C0022877 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of Sample Taken
Item
Date of Sample Taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Actual Sample Time
Item
Actual Sample Time
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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