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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01166633
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : April 4, 2013
Information provided by (Responsible Party):
JW Pharmaceutical

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

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Study Type : Interventional  (Clinical Trial)
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 : June 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pitavastatin 2 mg Drug: pitavastatin
pitavastatin 2mg per daily
Other Name: LIVALO

Active Comparator: Atorvastatin 10mg Drug: atorvastatin
atorvastatin 10mg per daily
Other Name: LIPITOR

Primary Outcome Measures :
  1. Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01166633

Sponsors and Collaborators
JW Pharmaceutical
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Principal Investigator: Kyoo-Rok Han Kangdong Sacred Heart Hospital
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Responsible Party: JW Pharmaceutical Identifier: NCT01166633    
Other Study ID Numbers: CWP-PTV-707
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013
Keywords provided by JW Pharmaceutical:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors