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

• Sponsor: JW Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01166633
• Collaborator: (none)
• Enrollment: 200
• Arms: 2
• Duration (Months): 20

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: pitavastatin; Drug: atorvastatin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment [12 weeks]

Secondary Outcome Measures

1. 1.Changes in ALT after treatment [12 weeks]

2. 2.Changes in AST after treatment [12 weeks]

3. 3.Changes in LDL-C, TC, TG and HDL-C after treatment [12 weeks]

4. 4.Changes in fat in liver after treatment [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• JW Pharmaceutical

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JW Pharmaceutical
• ClinicalTrials.gov Identifier: NCT01166633
• Other Study ID Numbers: CWP-PTV-707
• First Posted: Jul 21, 2010
• Last Update Posted: Apr 11, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by JW Pharmaceutical: Hydroxymethylglutaryl-CoA Reductase Inhibitors; hyperlipidemia
• Additional relevant MeSH terms: Hypercholesterolemia; Atorvastatin; Pitavastatin

Study Results

No Results Posted as of Apr 11, 2022