Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479401
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2007-05-25
Brief Title:
Efficacy Safety Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Double-blind Double-dummy Placebo-controlled Randomized Three Parallel Groups Study Comparing the Efficacy Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease PD
Status:
COMPLETED
Status Verified Date:
2014-06
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:
The objectives of this trial conducted in early Parkinsons Disease PD patients are to determine the efficacy as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinsons Disease Rating Scale UPDRS Parts II and III combined safety and tolerability of Pramipexole Extended Release ER in daily doses from 0375mg to 45mg qd in comparison to placebo and to test for non-inferiority between the two formulations ER and IR of pramipexole
In addition the efficacy of Pramipexole Immediate Release IR will be compared to placebo for assay sensitivity
In addition the efficacy of Pramipexole Immediate Release IR will be compared to placebo for assay sensitivity
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eudract No 2007-000073-39 | None | None | None |