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OpenTrials
Completed

NCT Number: NCT01166633

Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pitavastatin

Drug

pitavastatin 2mg per daily

Other names: LIVALO

atorvastatin

Drug

atorvastatin 10mg per daily

Other names: LIPITOR

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study 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

Acronym: PITCH

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jul 21, 2010
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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