Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

NCT01166633 | Completed Phase 4 DMC

• 1 other identifier: CWP-PTV-707
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Keywords

Hydroxymethylglutaryl-CoA Reductase Inhibitors; hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment

  12 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Pitavastatin 2 mg

EXPERIMENTAL

Drug: pitavastatin

Atorvastatin 10mg

ACTIVE COMPARATOR

Drug: atorvastatin

Interventions

pitavastatin DRUG

pitavastatin 2mg per daily

Also known as: LIVALO

Pitavastatin 2 mg

atorvastatin DRUG

atorvastatin 10mg per daily

Also known as: LIPITOR

Atorvastatin 10mg

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• JW Pharmaceutical: lead

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias

Interventions

pitavastatin; Atorvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Kyoo-Rok Han

  Kangdong Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: June 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: February 1, 2011
• Last Updated: April 11, 2022

Record last verified: 2022-04