Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274131
Status:
COMPLETED
Last Update Posted:
2012-05-21
First Post:
2006-01-09
Brief Title:
Long-term Administration Study of SND 919 Tablets in Parkinsons Disease
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Long-term Administration Study of SND 919 Tablets in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2012-05
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:
To evaluate the efficacy and safety of long-term treatment with pramipexole tablets BI Sifrol in Parkinsons disease phase III study
Detailed Description:
The efficacy and safety of long-term treatment with pramipexole BI Sifrol were evaluated in Parkinson disease patients in an open-label non-controlled design The treatment was initiated at 0125 mg bid after breakfast and supper
The dose was increased stepwise with due caution regarding the symptoms and safety of each patient up to 15 mg tid after each meal The treatment period was set at 56 weeks followed by a stepwise dosedecreasing period maximum 4 weeks
Study Hypothesis
Comparisons
The dose was increased stepwise with due caution regarding the symptoms and safety of each patient up to 15 mg tid after each meal The treatment period was set at 56 weeks followed by a stepwise dosedecreasing period maximum 4 weeks
Study Hypothesis
Comparisons
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