Status:
COMPLETED
Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia
Lead Sponsor:
JW Pharmaceutical
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
25-75 years
Phase:
PHASE4
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 req...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01166633
Start Date
June 1 2009
End Date
February 1 2011
Last Update
April 11 2022
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