ID
36877
Beskrivning
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.
Nyckelord
Versioner (2)
- 2017-10-15 2017-10-15 -
- 2019-06-18 2019-06-18 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
18 juni 2019
DOI
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Licens
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
Vital Signs 1
- StudyEvent: ODM
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
For Pre-dose you can take three measurements. The timing "Pre-dose" is only for Day 1.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Systolic Blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic Blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Pulse
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0232117
Similar models
Vital Signs 1
- StudyEvent: ODM
C1262869 (UMLS CUI [1,2])