Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134966
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2005-08-23
Brief Title:
A Study to Evaluate Fixed Dose CarbidopaLevodopaEntacapone Versus Immediate Release CarbidopaLevodopa
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A 39 Week Randomized Double-Blind Parallel Group Multicenter Study to Evaluate the Effect of Fixed Dose CarbidopaLevodopaEntacapone 100 mg tid vs Immediate Release CarbidopaLevodopa 25100 mg tid in Parkinsons Disease Patients Requiring Levodopa
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to achieve approval for the use of carbidopalevodopaentacapone in early Parkinsons disease PD by demonstrating that when used as initial levodopa therapy in early PD carbidopalevodopaentacapone provides significantly greater symptomatic benefit than immediate release carbidopalevodopa administered at the same levodopa dosage level of 100 mg three times a day tid
Detailed Description:
The purpose of this study is to achieve approval for the use of carbidopalevodopaentacapone in early Parkinsons disease PD by demonstrating that when used as initial levodopa therapy in early PD carbidopalevodopaentacapone provides significantly greater symptomatic benefit than immediate release carbidopalevodopa administered at the same levodopa dosage level 100 mg tid
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