ID
36877
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 Vital Signs 1. It has to be filled in at Day 1, Day 6, Day 8, Day 12, Day 15 and Day 19.
Mots-clés
Versions (2)
- 15/10/2017 15/10/2017 -
- 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
Vital Signs 1
- StudyEvent: ODM
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
For Pre-dose you can take three measurements. The timing "Pre-dose" is only for Day 1.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C0040223
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 [1,1]
- C2963216
- UMLS CUI [1,2]
- C1262869
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
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
Vital Signs 1
- StudyEvent: ODM
C1262869 (UMLS CUI [1,2])