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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

pitavastatin

atorvastatin

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hydroxymethylglutaryl-CoA Reductase Inhibitors, hyperlipidemia

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pitavastatin 2 mg

Atorvastatin 10mg

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

1.Changes in ALT after treatment

2.Changes in AST after treatment

3.Changes in LDL-C, TC, TG and HDL-C after treatment

4.Changes in fat in liver after treatment

Full Information

NCT ID

NCT01166633

First Posted

July 19, 2010

Last Updated

April 4, 2022

Sponsor

JW Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT01166633

Brief Title

Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

JW Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

Hydroxymethylglutaryl-CoA Reductase Inhibitors, hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pitavastatin 2 mg

Arm Type

Experimental

Arm Title

Atorvastatin 10mg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

pitavastatin

Other Intervention Name(s)

LIVALO

Intervention Description

pitavastatin 2mg per daily

Intervention Type

Drug

Intervention Name(s)

atorvastatin

Other Intervention Name(s)

LIPITOR

Intervention Description

atorvastatin 10mg per daily

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

1.Changes in ALT after treatment

Time Frame

12 weeks

Title

2.Changes in AST after treatment

Time Frame

12 weeks

Title

3.Changes in LDL-C, TC, TG and HDL-C after treatment

Time Frame

12 weeks

Title

4.Changes in fat in liver after treatment

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyoo-Rok Han

Organizational Affiliation

Kangdong Sacred Heart Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

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