ID

36878

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Vital Signs 2. It has to be filled in at Day 2, Day 3, Day 4, Day 5, Day 7, Day 9, Day 10, Day 11, Day 13, Day 14, Day 16, Day 17 and Day 18.

Keywords

Versions (2)
  1. 9/3/17 9/3/17 -
  2. 6/18/19 6/18/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 18, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

English

Vital Signs 2

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs 2
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Study week
Description

Study week

Data type

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0439230
Study day
Description

Study day

Data type

integer

Alias
UMLS CUI [1]
C2826182
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Study Time
Description

The timing "Pre-dose" is only for Day 2, Day 7, Day 9, Day 13 and Day 16. The Timing "+ 24 hrs" has to take prior to next dose.

Data type

integer

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Position at measurement
Description

Supine pulse and blood pressure will be made after the subject has been resting supine for a period of at least 10 minutes. Standing pulse and blood pressure will be made after the subject has been standing for 1 minute after the supine measurements.

Data type

integer

Alias
UMLS CUI [1,1]
C2963216
UMLS CUI [1,2]
C1262869
Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Blood pressure Systolic
Description

Systolic Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure Diastolic
Description

Diastolic Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Description

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
bpm
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Similar models

Vital Signs 2

1 forms
  1. StudyEvent: ODM
    1. Vital Signs 2
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Study week
integer
C0008972 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Study week
Code List
Study week
CL Item
Week 1 (1)
CL Item
Week 2 (2)
CL Item
Week 3 (3)
Item
Study day
integer
C2826182 (UMLS CUI [1])
Study day
Code List
Study day
CL Item
Day 2 (1)
CL Item
Day 3 (2)
CL Item
Day 4 (3)
CL Item
Day 5 (4)
CL Item
Day 7 (5)
CL Item
Day 9 (6)
CL Item
Day 10 (7)
CL Item
Day 11 (8)
CL Item
Day 13 (9)
CL Item
Day 14 (10)
CL Item
Day 16 (11)
CL Item
Day 17 (12)
CL Item
Day 18 (13)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Study Time
integer
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Study Time
Code List
Study Time
CL Item
Pre-dose (1)
CL Item
+ 2 hrs (2)
CL Item
+ 6 hrs (3)
CL Item
+ 16 hrs (4)
CL Item
+ 24 hrs (5)
Item
Position at measurement
integer
C2963216 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Position at measurement
Code List
Position at measurement
CL Item
Supine (1)
CL Item
Standing (2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Systolic Blood pressure
Item
Blood pressure Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Blood pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
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