ID
36892
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 12 LEAD ECG Monitoring form. It has to be filled in for Day 1, Day 6, Day 8, Day 12, Day 15 and Day 19.
Nyckelord
Versioner (2)
- 2017-09-02 2017-09-02 -
- 2019-06-19 2019-06-19 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
19 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
12 LEAD ECG Monitoring 1
- StudyEvent: ODM
Beskrivning
12 LEAD ECG MONITORING
Alias
- UMLS CUI-1
- C0430456
Beskrivning
Note: Pre-dose only has to be measured for Day 1.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1]
- C0040223
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
PR
Datatyp
float
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS
Datatyp
float
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C1880451
Beskrivning
QT
Datatyp
float
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
QTc
Datatyp
float
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0489625
Beskrivning
ECG normal
Datatyp
text
Alias
- UMLS CUI [1]
- C0522054
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
12 LEAD ECG Monitoring 1
- StudyEvent: ODM
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