ID

26756

Description

Study Part: PK Blood Sampling Week 5 PK Visit (Visit 9). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Keywords

Versions (1)
  1. 10/23/17 10/23/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 23, 2017

DOI

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License

Creative Commons BY-NC 3.0
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PK Blood Sampling Week 5 PK Visit (Visit 9) Ropinirole Parkinson Disease 101468/165

English

PK Blood Sampling Week 5 PK Visit (Visit 9)

1 forms  
PK BLOOD SAMPLING
Description

PK BLOOD SAMPLING

Alias
UMLS CUI-1
C0005834
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Time relative to start of dose
Description

start time dose

Data type

text

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0178602
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample Taken
Description

Sample Taken

Data type

boolean

Alias
UMLS CUI [1]
C1277698
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

PK Blood Sampling Week 5 PK Visit (Visit 9)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PK BLOOD SAMPLING
C0005834 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item
Time relative to start of dose
text
C1301880 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
start time dose
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+1 hr (+1 hr)
CL Item
+2 hrs (+2 hrs)
CL Item
+4 hr (+4 hr)
CL Item
+6 hrs (+6 hrs)
CL Item
+8 hrs (+8 hrs)
CL Item
+10 hrs (+10 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+14 hrs (+14 hrs)
CL Item
+16 hrs (+16 hrs)
CL Item
+20 hrs (+20 hrs)
CL Item
+24 hrs (+24 hrs)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C1277698 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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