ID
36876
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 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.
Trefwoorden
Versies (1)
- 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
Unscheduled Vital Signs and ECG Monitoring for Screening
- StudyEvent: ODM
Beschrijving
Unscheduled 12 Lead ECG Monitoring
Alias
- UMLS CUI-1
- C3854240
- UMLS CUI-2
- C0430456
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
If the abnormality is clinically significant, please withdraw the subject.
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Unscheduled Vital Signs
Alias
- UMLS CUI-1
- C3854240
- UMLS CUI-2
- C0518766
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]
- C1828063
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Systolic Blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Pulse
Datatype
integer
Maateenheden
- 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)