ID
36876
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 Unscheduled Vital Signs and ECG Monitoring for Screening form. It has to be filled in if there is an unscheduled measurement of vital sings and/or ECG at Screening.
Nyckelord
Versioner (1)
- 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
Unscheduled Vital Signs and ECG Monitoring for Screening
- StudyEvent: ODM
Beskrivning
Unscheduled 12 Lead ECG Monitoring
Alias
- UMLS CUI-1
- C3854240
- UMLS CUI-2
- C0430456
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
If the abnormality is clinically significant, please withdraw the subject.
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Unscheduled Vital Signs
Alias
- UMLS CUI-1
- C3854240
- UMLS CUI-2
- C0518766
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]
- C1828063
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1]
- C0040223
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
Unscheduled Vital Signs and ECG Monitoring for Screening
- StudyEvent: ODM
C0430456 (UMLS CUI-2)
C0518766 (UMLS CUI-2)