ID
36876
Descripción
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.
Palabras clave
Versiones (1)
- 18/6/19 18/6/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
18 de junio de 2019
DOI
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Licencia
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
Descripción
Unscheduled 12 Lead ECG Monitoring
Alias
- UMLS CUI-1
- C3854240
- UMLS CUI-2
- C0430456
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1]
- C0040223
Descripción
Heart rate
Tipo de datos
integer
Unidades de medida
- bpm
Alias
- UMLS CUI [1]
- C0018810
Descripción
PR
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1]
- C0429087
Descripción
QRS
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1]
- C1880451
Descripción
QT
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1]
- C1287082
Descripción
QTc
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1]
- C0489625
Descripción
ECG normal
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0522054
Descripción
If the abnormality is clinically significant, please withdraw the subject.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0947611
Descripción
Unscheduled Vital Signs
Alias
- UMLS CUI-1
- C3854240
- UMLS CUI-2
- C0518766
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1828063
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1]
- C0040223
Descripción
Systolic Blood pressure
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Descripción
Diastolic Blood pressure
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Descripción
Pulse
Tipo de datos
integer
Unidades de medida
- 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)