ID
36876
Description
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.
Mots-clés
Versions (1)
- 18/06/2019 18/06/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
18 juin 2019
DOI
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Licence
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
Description
Unscheduled 12 Lead ECG Monitoring
Alias
- UMLS CUI-1
- C3854240
- UMLS CUI-2
- C0430456
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
Heart rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
PR
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C1880451
Description
QT
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C1287082
Description
QTc
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0489625
Description
ECG normal
Type de données
text
Alias
- UMLS CUI [1]
- C0522054
Description
If the abnormality is clinically significant, please withdraw the subject.
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Unscheduled Vital Signs
Alias
- UMLS CUI-1
- C3854240
- UMLS CUI-2
- C0518766
Description
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.
Type de données
integer
Alias
- UMLS CUI [1]
- C1828063
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
Systolic Blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Pulse
Type de données
integer
Unités de mesure
- 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)