Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414869
Status:
TERMINATED
Last Update Posted:
2017-02-09
First Post:
2006-12-21
Brief Title:
Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
Preliminary Efficacy And Tolerability Of Oral NCX-1000 After Repeated Administrations In Patients With Portal Hypertension A Double-Blind Dose Escalating Study
Status:
TERMINATED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Preliminary analysis of 11 patients did not demonstrate the efficacy required
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic liver diseases are often characterized by portal hypertension a major complication involving haemodynamic changes due to increased intrahepatic vascular resistance It has become well established that nitric oxide NO plays a crucial role in the haemodynamic abnormalities that develop in chronic portal hypertension
NCX-1000 is a NO-releasing derivative of ursodeoxycholic acid that would compensate for the defective liver NO production in cirrhosis
This study intends to demonstrate the desired therapeutic activity reduction in portal pressure in a small number of target patients to assess the safety and tolerability after repeated oral administrations of NCX-1000 and to get preliminary pharmacokinetic data in this population
NCX-1000 is a NO-releasing derivative of ursodeoxycholic acid that would compensate for the defective liver NO production in cirrhosis
This study intends to demonstrate the desired therapeutic activity reduction in portal pressure in a small number of target patients to assess the safety and tolerability after repeated oral administrations of NCX-1000 and to get preliminary pharmacokinetic data in this population
Detailed Description:
Brief summary is complete Study is closed
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