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Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension

NCT00594191 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2008-01-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and portal hypertension.

Conditions

  • Cirrhosis
  • Portal Hypertension

Interventions

DRUG

Simvastatin

20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met

DRUG

Placebo

Placebo with the same characteristics of the drug and at the same dose

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Jaime Bosch, MD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2007-04-30
Completion
2007-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00594191 on ClinicalTrials.gov