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

April 4, 2022 updated by: JW Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atorvastatin 10mg
Drug: atorvastatin
atorvastatin 10mg per daily
Other Names:
  • LIPITOR
Experimental: Pitavastatin 2 mg
Drug: pitavastatin
pitavastatin 2mg per daily
Other Names:
  • LIVALO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
1.Changes in ALT after treatment
Time Frame: 12 weeks
12 weeks
2.Changes in AST after treatment
Time Frame: 12 weeks
12 weeks
3.Changes in LDL-C, TC, TG and HDL-C after treatment
Time Frame: 12 weeks
12 weeks
4.Changes in fat in liver after treatment
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Kyoo-Rok Han, Kangdong Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

July 19, 2010

First Submitted That Met QC Criteria

July 20, 2010

First Posted (Estimate)

July 21, 2010

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWP-PTV-707

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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