Ignite Creation Date:
2025-12-17 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 3:47 AM
Study NCT ID:
NCT00737594
Status:
TERMINATED
Last Update Posted:
2019-11-18
First Post:
2008-08-15
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
Sponsor:
Sucampo Pharma Americas, LLC
Organization:
Study Overview
Official Title:
A Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to enroll a suitable number of qualified subjects.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: