ID

36893

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 12 LEAD ECG Monitoring 2 form. It has to be filled in for Day 2, Day 3, Day 4, Day 5, Day 7, Day 9, Day 10, Day 11, Day 13, Day 14, Day 16, Day 17 and Day 18.

Palabras clave

  1. 2/9/17 2/9/17 -
  2. 19/6/19 19/6/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

19 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

12 LEAD ECG Monitoring 2

Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Study Week
Descripción

Study Week

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0439230
Study Day
Descripción

Study Day

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826182
12 LEAD ECG MONITORING
Descripción

12 LEAD ECG MONITORING

Alias
UMLS CUI-1
C0430456
Study Time
Descripción

Note: Pre-dose only has to be measured for Day 2, Day 7, Day 9, Day 13, Day 16. Timing +24 hrs has to be measured prior to next dose.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Date
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Descripción

00:00-23:59

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Descripción

PR

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Descripción

QRS

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Descripción

QT

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Descripción

QTc

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal?
Descripción

ECG normal

Tipo de datos

text

Alias
UMLS CUI [1]
C0522054
Comments
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611

Similar models

12 LEAD ECG Monitoring 2

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Study Week
integer
C0008972 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Code List
Study Week
CL Item
Week 1 (1)
CL Item
Week 2 (2)
CL Item
Week 3 (3)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Code List
Study Day
CL Item
Day 2 (1)
CL Item
Day 3 (2)
CL Item
Day 4 (3)
CL Item
Day 5 (4)
CL Item
Day 7 (5)
CL Item
Day 9 (6)
CL Item
Day 10 (7)
CL Item
Day 11 (8)
CL Item
Day 13 (9)
CL Item
Day 14 (10)
CL Item
Day 16 (11)
CL Item
Day 17 (12)
CL Item
Day 18 (13)
Item Group
12 LEAD ECG MONITORING
C0430456 (UMLS CUI-1)
Item
Study Time
integer
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Code List
Study Time
CL Item
Pre-dose  (1)
CL Item
+2 hrs  (2)
CL Item
+6 hrs  (3)
CL Item
+16 hrs (4)
CL Item
+24 hrs (5)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C0429087 (UMLS CUI [1])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1])
QT
Item
QT
float
C1287082 (UMLS CUI [1])
QTc
Item
QTc
float
C0489625 (UMLS CUI [1])
Item
ECG normal?
text
C0522054 (UMLS CUI [1])
Code List
ECG normal?
CL Item
Yes (Y)
CL Item
No (N)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])

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