Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized , Open Label, Dose Titration Study to Evaluate the Effect of Pitavastatin Versus Atorvastatin in Patients With Hypercholesterolemia and Mild to Moderate Hepatic Damage

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: pitavastatin
* Drug: atorvastatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin 2 mg<br> | Drug: pitavastatin<br>* pitavastatin 2mg per daily<br>* Other names: LIVALO;|
| Active Comparator: Atorvastatin 10mg<br> | Drug: atorvastatin<br>* atorvastatin 10mg per daily<br>* Other names: LIPITOR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Changes in ALT after treatment |  | 12 weeks | 
| 2.Changes in AST after treatment |  | 12 weeks | 
| 3.Changes in LDL-C, TC, TG and HDL-C after treatment |  | 12 weeks | 
| 4.Changes in fat in liver after treatment |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydroxymethylglutaryl-CoA Reductase Inhibitors, hyperlipidemia