Pravastatin Efficacy and Safety Trial in Hypercholesterol... | NCT00529178

Studies
Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease

NCT00529178

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Apr 25, 2011Estimated

Enrollment

232Estimated

Phase

Phase 4

Conditions

Hypercholesterolemia

Interventions

Pravastatin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2002

Primary Completion Date

Mar 2005Actual

Completion Date

Mar 2005Actual

First Submitted Date

Sep 13, 2007

First Submission Date that Met QC Criteria

Sep 13, 2007

First Posted Date

Sep 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 12, 2011

Certification/Extension First Submitted that Passed QC Review

Apr 12, 2011

Certification/Extension First Posted Date

Apr 25, 2011Estimated

Last Update Submitted Date

Apr 12, 2011

Last Update Posted Date

Apr 25, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

232Estimated

Name	Type	Description	Arm Group Labels	Other Names
Pravastatin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum LDL-C		at week 12
ALT value

Secondary Outcomes

Measure	Description	Time Frame
change in HDL-C, TC and TG		at week 12
clinical symptoms related to acute hepatic injury

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic, well-compensated stable liver
Hypercholesterolemia

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17668878	Derived	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.

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic