NCT00529178

Brief Summary

To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to placebo.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2002

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
Last Updated

April 25, 2011

Status Verified

April 1, 2011

Enrollment Period

2.2 years

First QC Date

September 13, 2007

Last Update Submit

April 12, 2011

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

  • serum LDL-C

    at week 12

  • ALT value

Secondary Outcomes (2)

  • change in HDL-C, TC and TG

    at week 12

  • clinical symptoms related to acute hepatic injury

Interventions

PravastatinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic, well-compensated stable liver
  • Hypercholesterolemia

You may not qualify if:

  • Signs or symptoms of ascites, jaundice, or cirrhosis with a Child-Pugh Score \> 5
  • History of disorders affecting serum bilirubin levels, more than 1 chronic liver disease, significant endocrine, renal, or gastrointestinal disease, or uncontrolled hypertension
  • Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lewis JH, Mortensen ME, Zweig S, Fusco MJ, Medoff JR, Belder R; Pravastatin in Chronic Liver Disease Study Investigators. Efficacy and safety of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease: Results of a prospective, randomized, double-blind, placebo-controlled, multicenter trial. Hepatology. 2007 Nov;46(5):1453-63. doi: 10.1002/hep.21848.

    PMID: 17668878DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 14, 2007

Study Start

December 1, 2002

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

April 25, 2011

Record last verified: 2011-04