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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01166633
First received: July 19, 2010
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166633

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

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01166633     History of Changes
Other Study ID Numbers: CWP-PTV-707
Study First Received: July 19, 2010
Last Updated: April 2, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by JW Pharmaceutical:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
hyperlipidemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014