Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485069
Status:
COMPLETED
Last Update Posted:
2010-12-15
First Post:
2007-06-11
Brief Title:
REQUIP Ropinirole Hydrochloride IR Long-Term Phase 4 Study
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Post-Marketing Clinical Study of REQUIP Ropinirole Hydrochloride Tablets in Patients With Parkinsons Disease- Evaluation of Long-Term Efficacy and Safety -
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ropinirole Hydrochloride ROP was granted approval for the treatment of Parkinsons Disease PD on 20 October 2006
ROP is expected to be used for a long term in clinical practice However no long-term clinical data with ROP administered three times daily are currently available from Japanese patients and the clinical experience with ROP at 10mgday is limited
For this reason this study was designed as a multicenter open-label uncontrolled study
This study will evaluate the long-term efficacy Japanese Unified Parkinsons Disease Rating Scale UPDRS Awake time spent OffOn Modified Hoehn Yahr stage Schwab-England scale Proportion of subjects remaining in this study and Clinical Global Impression CGI and the long-term safety of ROP administered three times daily for in PD patients
ROP is expected to be used for a long term in clinical practice However no long-term clinical data with ROP administered three times daily are currently available from Japanese patients and the clinical experience with ROP at 10mgday is limited
For this reason this study was designed as a multicenter open-label uncontrolled study
This study will evaluate the long-term efficacy Japanese Unified Parkinsons Disease Rating Scale UPDRS Awake time spent OffOn Modified Hoehn Yahr stage Schwab-England scale Proportion of subjects remaining in this study and Clinical Global Impression CGI and the long-term safety of ROP administered three times daily for in PD patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None