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

This study has been completed.
Information provided by (Responsible Party):
JW Pharmaceutical Identifier:
First received: July 19, 2010
Last updated: April 2, 2013
Last verified: April 2013
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 Intervention Phase
Hypercholesterolemia Drug: pitavastatin Drug: atorvastatin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by JW Pharmaceutical:

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

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

Enrollment: 200
Study Start Date: June 2009
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01166633

Sponsors and Collaborators
JW Pharmaceutical
Principal Investigator: Kyoo-Rok Han Kangdong Sacred Heart Hospital
  More Information

Responsible Party: JW Pharmaceutical Identifier: NCT01166633     History of Changes
Other Study ID Numbers: CWP-PTV-707
Study First Received: July 19, 2010
Last Updated: April 2, 2013

Keywords provided by JW Pharmaceutical:
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors processed this record on September 21, 2017