ID

20020

Description

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.

Keywords

Versions (2)
  1. 12/19/16 12/19/16 -
  2. 2/4/17 2/4/17 -
Uploaded on

February 4, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Visit 6 PK - Blood Sample for ASP1941 and Metformin [PC_2] NCT01117584

English

Visit 6 PK - Blood Sample for ASP1941 and Metformin [PC_2] NCT01117584

1 forms  
General Information
Description

General Information

Specimen Material Type: Plasma
Description

Specimen Material Type

Data type

boolean

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

Date of Dose of ASP1941

Data type

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
Description

Time of Dose of ASP1941

Data type

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
Description

Date of Dose of Metformin

Data type

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
Description

Time of 1st Dose of Metformin On Day of Sampling

Data type

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
Description

Dose of Metformin

Data type

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
Description

Time of 2nd Dose of Metformin On Day of Sampling

Data type

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
Description

Dose of 2nd Metfomin

Data type

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
Description

Time of 3rd Dose of Metformin On Day Of Sampling

Data type

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
Description

Dose of 3rd Metformin

Data type

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
Description

Time of 4th Dose of Metformin On Day Of Sampling

Data type

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
Description

Dose of 4th Metformin

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Date of Dose of Metformin on day before Sampling

Data type

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
Description

Time of last Dose of Metformin on Day before Sampling

Data type

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
Description

Dose of last time Metformin

Data type

text

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

Scheduled time

Data type

text

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C1301732
Not Done (Check if sample Not Drawn or Not Sent to Lab)
Description

Not Done

Data type

boolean

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

Requisition Number

Data type

integer

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

Date of Sample Taken

Data type

date

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

Actual Sample Time

Data type

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
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Similar models

Visit 6 PK - Blood Sample for ASP1941 and Metformin [PC_2] NCT01117584

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
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
C0025598 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
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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