Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

Hypercholesterolemia Clinical Trial

— PITCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166633
• Other study ID #: CWP-PTV-707
• Status: Completed
• Phase: Phase 4
• Start date: June 2009
• Est. completion date: February 2011

Study information

• Verified date: April 2022
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• pitavastatin
pitavastatin 2mg per daily
• atorvastatin
atorvastatin 10mg per daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment		12 weeks
Secondary	1.Changes in ALT after treatment		12 weeks
Secondary	2.Changes in AST after treatment		12 weeks
Secondary	3.Changes in LDL-C, TC, TG and HDL-C after treatment		12 weeks
Secondary	4.Changes in fat in liver after treatment		12 weeks