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

July 19, 2010
April 2, 2013
June 2009
November 2010   (final data collection date for primary outcome measure)
Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT01166633 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: pitavastatin
    pitavastatin 2mg per daily
    Other Name: LIVALO
  • Drug: atorvastatin
    atorvastatin 10mg per daily
    Other Name: LIPITOR
  • Experimental: Pitavastatin 2 mg
    Intervention: Drug: pitavastatin
  • Active Comparator: Atorvastatin 10mg
    Intervention: Drug: atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
February 2011
November 2010   (final data collection date for primary outcome measure)

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.
Both
25 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01166633
CWP-PTV-707
Yes
JW Pharmaceutical
JW Pharmaceutical
Not Provided
Principal Investigator: Kyoo-Rok Han Kangdong Sacred Heart Hospital
JW Pharmaceutical
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP