ID
36390
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 informed consent and demographic of subject form. It has to be filled in for screening.
Keywords
Versions (2)
- 8/31/17 8/31/17 -
- 5/10/19 5/10/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 10, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201
Informed consent, Demography
- StudyEvent: ODM
Description
Informed Consent History
Alias
- UMLS CUI-1
- C0021430
Description
DEMOGRAPHY
Alias
- UMLS CUI-1
- C0011298
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
integer
Alias
- UMLS CUI [1]
- C0034510
Description
Other Race
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0034510
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index calculated using the following formula: Body Mass Index = ( Weight (kg) / (Height (cm) )² ) x 10,000
Data type
float
Measurement units
- kg/m²
Alias
- UMLS CUI [1]
- C1305855
Description
Clinical Staff Signature
Data type
text
Alias
- UMLS CUI [1,1]
- C0025106
- UMLS CUI [1,2]
- C1519316
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Informed consent, Demography
- StudyEvent: ODM
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0034510 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])