ID

36912

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 and follow-up form.

Palabras clave

Versiones (2)
  1. 18/6/19 18/6/19 -
  2. 21/6/19 21/6/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

21 de junio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

Inglés

Vital Signs and ECG Monitoring for Screening and Follow-up

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Descripción

Volunteer panel number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Study Visit
Descripción

Study Visit

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0545082
12 LEAD ECG MONITORING
Descripción

12 LEAD ECG MONITORING

Alias
UMLS CUI-1
C0430456
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
Comment
Descripción

If the abnormality is clinically significant, please withdraw the subject

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Body position for blood pressure measurement
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
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
Systolic Blood pressure
Descripción

Systolic Blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Descripción

Diastolic Blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Descripción

Pulse

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Volver a la parte superior de la página

Similar models

Vital Signs and ECG Monitoring for Screening and Follow-up

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Volunteer panel number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Study Visit
integer
C0008972 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Study Visit
Code List
Study Visit
CL Item
Screening (1)
CL Item
Follow-up (2)
Item Group
12 LEAD ECG MONITORING
C0430456 (UMLS CUI-1)
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])
ECG normal
Code List
ECG normal?
CL Item
Yes (Y)
CL Item
No (N)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Body position for blood pressure measurement
integer
C1828063 (UMLS CUI [1])
Body position for blood pressure measurement
Code List
Body position for blood pressure measurement
CL Item
Supine (1)
CL Item
Standing (2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial