Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

NCT ID: NCT01166633

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-02-28

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pitavastatin 2 mg

Group Type: EXPERIMENTAL

pitavastatin

Intervention Type: DRUG

pitavastatin 2mg per daily

Atorvastatin 10mg

Group Type: ACTIVE_COMPARATOR

atorvastatin

Intervention Type: DRUG

atorvastatin 10mg per daily

Interventions

pitavastatin

pitavastatin 2mg per daily

Intervention Type: DRUG

atorvastatin

atorvastatin 10mg per daily

Intervention Type: DRUG

Other Intervention Names

LIVALO; LIPITOR

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

JW Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyoo-Rok Han

Role: PRINCIPAL_INVESTIGATOR

Kangdong Sacred Heart Hospital

Other Identifiers

CWP-PTV-707

Identifier Type: -

Identifier Source: org_study_id