NCT00844402

Brief Summary

Primary biliary cirrhosis (PBC) is frequently associated with hypercholesterolemia and possibly with an increased cardiovascular morbidity and mortality. Statins lower serum cholesterol levels and may thus improve the cardiovascular risk in PBC patients. The aim of our study therefore was to prospectively examine the efficacy of low-dose atorvastatin on indicators of cardiovascular risk such as dyslipidemia and vascular function as well as safety in patients with PBC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

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

January 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
Last Updated

February 16, 2009

Status Verified

February 1, 2009

Enrollment Period

1.8 years

First QC Date

February 13, 2009

Last Update Submit

February 13, 2009

Conditions

Primary Biliary CirrhosisHypercholesterolemia

Keywords

CholestasisAtherosclerosisStatinsVascular function

Outcome Measures

Primary Outcomes (1)

  • Low-density lipoprotein cholesterol (LDL-C)

    week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60

Secondary Outcomes (3)

  • Intima-media thickness of the common carotid artery (IMT), vascular wall stiffness (stiffness index SI), flow-mediated dilation of the brachial artery (FMD)

    week 0, 48

  • Total cholesterol, triglycerides, VLDL-C, HDL-C, lipid profile, hs-CRP, AP, GGT, bilirubin, bile acids, immunoglobins

    week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60

  • AST, ALT, CK, PZ, AT, albumin, creatinine, blood cell count

    week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60

Study Arms (1)

Atorvastatin

EXPERIMENTAL

Atorvastatin 10 mg per day for 48 weeks

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

oral, 10 mg, daily, 48 weeks

Also known as: Sortis10 mg, 1-21927, C10AA05
Atorvastatin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LDL-cholesterol \> 130 mg/dl
  • Primary biliary cirrhosis (AMA positive or biopsy proven)
  • Male or female gender
  • Age 18-70 years
  • Normal kidney function

You may not qualify if:

  • Primary biliary cirrhosis Stage III-IV (Ludwig Score)
  • Liver cirrhosis
  • Decompensated liver disease ( \> Child-Pugh class B, ascites, esophageal varices)
  • ALT or AST \> 2x ULN
  • Pregnancy or breastfeeding
  • Premenopausal women without certain contraception
  • Known hypersensitivity to HMG-CoA reductase inhibitors
  • Current treatment with lipid-lowering agents other than atorvastatin; immunosuppressants, macrolides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (1)

  • Stojakovic T, Claudel T, Putz-Bankuti C, Fauler G, Scharnagl H, Wagner M, Sourij H, Stauber RE, Winkler K, Marz W, Wascher TC, Trauner M. Low-dose atorvastatin improves dyslipidemia and vascular function in patients with primary biliary cirrhosis after one year of treatment. Atherosclerosis. 2010 Mar;209(1):178-83. doi: 10.1016/j.atherosclerosis.2009.08.052. Epub 2009 Sep 6.

    PMID: 19782361DERIVED

MeSH Terms

Conditions

Liver Cirrhosis, BiliaryHypercholesterolemiaCholestasisAtherosclerosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Michael Trauner, M.D.

    Medical University of Graz, Department of Internal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 16, 2009

Study Start

January 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

February 16, 2009

Record last verified: 2009-02

Locations

AU(1)