Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: JW Pharmaceutical
• Treatments: Atorvastatin; Atorvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pitavastatin

Criteria

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.