ID

36877

Beschrijving

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 1. It has to be filled in at Day 1, Day 6, Day 8, Day 12, Day 15 and Day 19.

Trefwoorden

Versies (2)
  1. 15-10-17 15-10-17 -
  2. 18-06-19 18-06-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

18 juni 2019

DOI

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Licentie

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

Engels

Vital Signs 1

1 Formulieren  
  1. StudyEvent: ODM
    1. Vital Signs 1
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Study week
Beschrijving

Study week

Datatype

integer

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

Study day

Datatype

integer

Alias
UMLS CUI [1]
C2826182
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Study Time
Beschrijving

For Pre-dose you can take three measurements. The timing "Pre-dose" is only for Day 1.

Datatype

integer

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

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.

Datatype

integer

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

day month year

Datatype

date

Alias
UMLS CUI [1]
C0011008
Systolic Blood pressure
Beschrijving

Systolic Blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Beschrijving

Diastolic Blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Beschrijving

Pulse

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
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Similar models

Vital Signs 1

1 Formulieren
  1. StudyEvent: ODM
    1. Vital Signs 1
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
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 1 (1)
CL Item
Day 6 (2)
CL Item
Day 8 (3)
CL Item
Day 12 (4)
CL Item
Day 15 (5)
CL Item
Day 19 (6)
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
+ 0,5 hr (2)
CL Item
+ 1 hr (3)
CL Item
+ 1,5 hrs (4)
CL Item
+ 2 hrs (5)
CL Item
+ 3 hrs (6)
CL Item
+ 4 hrs (7)
CL Item
+ 6 hrs (8)
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
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
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