Skip to content

Eficacy and safety of atorvastatin for the treatment of nonalcoholic fatty liver disease in Chinese Han people: a randomized double-blinded placebo-controlled trial

Eficacy and safety of atorvastatin for the treatment of nonalcoholic fatty liver disease in Chinese Han people: a randomized double-blinded placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001451
Enrollment
Unknown
Registered
2011-06-21
Start date
2011-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nonalcoholic fatty liver disease

Interventions

1:atorvastatin 40mg QD given orally
2:placebo QD given orally

Sponsors

the 1st Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: All patients had compensated liver diseasewith hemoglobin values of 12 g/dL or greater in females and13 g/dL or greater for males, a white blood cell countof >3000/mm3, neutrophil count >1500/mm3, platelets>70,000/mm3, albumin >3.0 g/dL, in addition to normaltotal bilirubin, prothrombin time, and Internationalnormalized ratio. Other requirements included serumcreatinine 200 mg/dL,LDL >130 mg/dL, or TGs >200 mg/dL.

Exclusion criteria

Exclusion criteria: Any other cause of chronic liver disease; history of alcohol consumption greater than 1 drink per day, prior surgical disease to include gastroplasty; jejuno-ileal or jejuno-colic bypass; prior exposure to organic solvents such as carbon tetrachloride; total parenteral nutrition within the previous 6 months, prior organ transplantation; prior treatment with a statin within the past 12 weeks, or use of tamoxifen, prednisone, chloroquine, methotrexate, highly active retroviral therapy, amiodarone, or any other hepatoxic medications. Additionally, patients with serum transaminases greater than or equal to 3 times the upper limit of normal were excluded.

Design outcomes

Primary

MeasureTime frame
liver biopsy;

Secondary

MeasureTime frame
ultrasonographic exam of liver;

Countries

China

Contacts

Public ContactXiang-Jun Yang
yang_xiangjun@163.com+86 0512 65210279

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026