NCT00414869

Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure

Preliminary Efficacy And Tolerability Of Oral NCX-1000 After Repeated Administrations In Patients With Portal Hypertension: A Double-Blind Dose Escalating Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Brief summary is complete. Study is closed.

Conditions

• Portal Hypertension

Interventions

Type	Name	Description
DRUG	NCX-1000	500 mg powder sachets to be taken as 1, 2, or 4 sachets twice daily, PO x 16 days
DRUG	Placebo	Inactive powder matching NCX-1000

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2006-12-22
• Last updated: 2017-02-09

Locations

1 site across 1 country: Spain