Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia (PITCH)

JW Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Hypercholesterolemia

Treatments

Drug: atorvastatin

Drug: pitavastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01166633

CWP-PTV-707

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

25 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.