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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01166633

Acronym

PITCH

Enrollment

200

Registered

2010-07-21

Start date

2009-06-30

Completion date

2011-02-28

Last updated

2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Hydroxymethylglutaryl-CoA Reductase Inhibitors, hyperlipidemia

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.

Interventions

DRUGpitavastatin

pitavastatin 2mg per daily

DRUGatorvastatin

atorvastatin 10mg per daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment	12 weeks

Secondary

Measure	Time frame
1.Changes in ALT after treatment	12 weeks
2.Changes in AST after treatment	12 weeks
3.Changes in LDL-C, TC, TG and HDL-C after treatment	12 weeks
4.Changes in fat in liver after treatment	12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026