Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150553
Status:
COMPLETED
Last Update Posted:
2007-11-02
First Post:
2005-09-06
Brief Title:
Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
Sponsor:
Validus Pharmaceuticals
Organization:
Validus Pharmaceuticals
Study Overview
Official Title:
A Phase IIIb Randomized Double-Blind Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms
Status:
COMPLETED
Status Verified Date:
2006-05
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 compare the efficacy and safety of SPD417 in treating bipolar manic symptoms when given once daily in the evening vs twice daily
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