ID

35124

Descripción

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 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

Palabras clave

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

GlaxoSmithKline

Subido en

18 de febrero 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.

Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

Inglés

Week 12/ Early Withdrawal - Vital Signs; Rebound Question; Follow-Up - Vital Signs; Subject's Food Intake

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Week 12/ Early Withdrawal - Vital Signs
Descripción

Week 12/ Early Withdrawal - Vital Signs

Alias
UMLS CUI-1
C0518766
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
Subject position
Descripción

Subject position

Tipo de datos

integer

Alias
UMLS CUI [1]
C1262869
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Rebound Question
Descripción

Rebound Question

Alias
UMLS CUI-1
C0549262
UMLS CUI-2
C1522634
During the last week of treatment, has the subject experienced symptoms of rebound the morning after taking their dose of investigational product (i.e., rebound defined as a re-emergence of RLS symptoms in the early morning the day after taking the dose of RLS medication)?
Descripción

If Yes, record in the Adverse Event section of the CRF.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0549262
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0035258
Follow-Up - Vital Signs
Descripción

Follow-Up - Vital Signs

Alias
UMLS CUI-1
C0518766
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
Subject position
Descripción

Subject position

Tipo de datos

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Subject's Food Intake
Descripción

Subject's Food Intake

Alias
UMLS CUI-1
C0518037
Date and time of finishing last meal prior to the Follow-Up Visit:
Descripción

Note: ECG measures should be taken two or more hours after a meal.

Tipo de datos

datetime

Alias
UMLS CUI [1]
C0578574
Volver a la parte superior de la página

Similar models

Week 12/ Early Withdrawal - Vital Signs; Rebound Question; Follow-Up - Vital Signs; Subject's Food Intake

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Week 12/ Early Withdrawal - Vital Signs
C0518766 (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])
Item
Subject position
integer
C1262869 (UMLS CUI [1])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
CL Item
Semi-supine (4)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Rebound Question
C0549262 (UMLS CUI-1)
C1522634 (UMLS CUI-2)
During the last week of treatment, has the subject experienced symptoms of rebound the morning after taking their dose of investigational product
Item
During the last week of treatment, has the subject experienced symptoms of rebound the morning after taking their dose of investigational product (i.e., rebound defined as a re-emergence of RLS symptoms in the early morning the day after taking the dose of RLS medication)?
boolean
C0549262 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,4])
Item Group
Follow-Up - Vital Signs
C0518766 (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])
Item
Subject position
integer
C1262869 (UMLS CUI [1])
Subject position
Code List
Subject position
CL Item
Supine  (1)
CL Item
Sitting  (2)
CL Item
Standing  (3)
CL Item
Semi-supine (4)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Subject's Food Intake
C0518037 (UMLS CUI-1)
Date and time of finishing last meal prior to the Follow-Up Visit:
Item
Date and time of finishing last meal prior to the Follow-Up Visit:
datetime
C0578574 (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