ID
36893
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 12 LEAD ECG Monitoring 2 form. It has to be filled in for 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.
Trefwoorden
Versies (2)
- 02-09-17 02-09-17 -
- 19-06-19 19-06-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
19 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
12 LEAD ECG Monitoring 2
- StudyEvent: ODM
Beschrijving
12 LEAD ECG MONITORING
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Note: Pre-dose only has to be measured for Day 2, Day 7, Day 9, Day 13, Day 16. Timing +24 hrs has to be measured prior to next dose.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C1880451
Beschrijving
QT
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
ECG normal
Datatype
text
Alias
- UMLS CUI [1]
- C0522054
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
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12 LEAD ECG Monitoring 2
- StudyEvent: ODM