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

Tracking Information
First Received Date ^ICMJE	December 21, 2006
Last Updated Date	November 16, 2007
Start Date ^ICMJE	November 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: December 21, 2006)	The Hepatic Venous Pressure Gradient (HVPG) will be evaluated at entry (Day 1) and after the Maximal Tolerated Dose (MTD) on Day 16, in fasting and post-prandial (after a standardized liquid breakfast) states.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00414869 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 21, 2006)	Safety parameters: systolic and diastolic blood pressures, heart rate, physical examination, laboratory tests and Adverse Events (AEs) Plasma levels of NCX-1000 and its main metabolites will be evaluated to get preliminary pharmacokinetic data.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure
Official Title ^ICMJE	Preliminary Efficacy And Tolerability Of Oral NCX-1000 After Repeated Administrations In Patients With Portal Hypertension: A Double-Blind Dose Escalating Study
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Portal Hypertension
Intervention ^ICMJE	Drug: NCX-1000
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	11
Completion Date	February 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Criteria: 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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT ID ^ICMJE	NCT00414869
Responsible Party
Study ID Numbers ^ICMJE	NCXDE05-02
Study Sponsor ^ICMJE	Axcan Pharma
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Axcan Pharma
Verification Date	November 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP