Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: pitavastatin; Drug: atorvastatin

• Registration Number: NCT01166633
• Lead Sponsor: JW Pharmaceutical

Brief Summary

Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive monitoring is required.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Primary Completion: 2010-11
• Study Completion: 2011-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients aged between 25 and 75
• Patients who signed informed consent forms of their own volition;
• Patients who had taken statins for 2 months and longer or whose fasting LDL-C levels, were 130mg/dL and over (Friedewald's formula);
• Patients whose ALT levels were 1.25 to 2.5 times higher than the upper limit of normal

Exclusion Criteria

• Patients with uncompensated liver cirrhosis.
• Patients whose total bilirubin levels were over 2 times higher than the upper limit of normal.
• Patients who had taken antiviral drugs for viral hepatitis.
• Patients who experienced cerebrovascular diseases or myocardial infarction within 3 months before screening visit or patients with heart failure (NYHA class IV).
• Patients whose triglyceride(TG) levels were 400mg/dL or higher.
• Patients with uncontrolled hypertension (DBP≧100mmHg)
• Patients under suspicion of renal dysfunction (serum creatinine≧2.0mg/dL)
• Patients whose CK levels were over 2.5 times higher than the upper limit of normal.
• Patients with uncontrolled hypothyroidism although drug treatment (TSH≧ULN×1.5)
• Female patients who were nursing or being pregnant or were planning on becoming pregnant.
• Patients judged to be unsuitable by investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin 2 mg	pitavastatin	-
Atorvastatin 10mg	atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment	12 weeks

Secondary Outcome Measures

Name	Time	Method
4.Changes in fat in liver after treatment	12 weeks
3.Changes in LDL-C, TC, TG and HDL-C after treatment	12 weeks
1.Changes in ALT after treatment	12 weeks
2.Changes in AST after treatment	12 weeks