Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479336
Status:
COMPLETED
Last Update Posted:
2014-03-14
First Post:
2007-05-25
Brief Title:
A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema
Sponsor:
Otsuka Pharmaceutical Co Ltd
Organization:
Otsuka Pharmaceutical Co Ltd
Study Overview
Official Title:
A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema
Status:
COMPLETED
Status Verified Date:
2014-01
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 investigate the dose response for changes from baseline in body weight as a primary endpoint and to investigate improvement in ascites abdominal circumference lower-limb edema and pleural effusion as secondary endpoints in seven-day repeated oral administration of OPC-41061 at 75 15 and 30 mgday or placebo in cirrhosis patients with ascites despite taking conventional diuretics
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