Status:
TERMINATED
Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure
Lead Sponsor:
Forest Laboratories
Conditions:
Portal Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 establi...
Detailed Description
Brief summary is complete. Study is closed.
Eligibility Criteria
Inclusion
- Male or non-pregnant female patients of at least 18 years old
- HVPG \> 12 mm Hg in fasting state on Day 1
- Free of any other condition (except liver failure) that may alter absorption, distribution, or elimination of drugs
Exclusion
- Oesophageal bleeding in the previous 30 days
- Known intolerance to ursodeoxycholic acid or nitrates
- Liver cancer or liver metastasis from another cancer
- Portal hypertension secondary to venous thrombosis
- Presence of Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Severe liver failure (Child-Pugh C)
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00414869
Start Date
November 1 2005
End Date
February 1 2007
Last Update
February 9 2017
Active Locations (1)
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1
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036