Clinical study of atorvastatin on patients with hyperlipidemia. Comparison of the efficacy and safety between the original drug and its generic drug

Clinical study of atorvastatin on patients with hyperlipidemia. Comparison of the efficacy and safety between the original drug and its generic drug - Comparative study between the original drug of atorvastatin and its generic drug

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007302

Enrollment

100

Registered

2012-02-26

Start date

2012-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Patients with hyperlipidemia who have been treated with Lipitor

Interventions

Atorvastatin Tablet [Nichiiko] QD, 12 weeks Lipitor QD, 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who have been treated with Lipitor 10 mg for more than 12 weeks (2)Patients whose LDL-C has been controlled not more than 140 mg/dL. (3) Patients whose written consent is obtained

Exclusion criteria

Exclusion criteria: (1) Familial hypercholesteremia (2) Secondary hyperlipidemia or drug-induced hyperlipidemia (3) Fasting serum triglyceride <= 400 mg/dL (4) A history of stroke, ischemic heart disease or cerebral embolism during the previous 24 weeks (5) One of the following severe diseases; Cancer, hypertension (SAP <= 180 mmHg or DBP <= 110 mmHg), Type I diabetes, severe liver disease (ALT/AST <= 100 IU/L and T-Bil < 2.5 mg/dL), and renal dysfunction (eGFR > 30 mL/min/1.73 m2) (6) A history of hypersensitivity to statins (7) A patient who is not candidates for Lipitor therapy (8) Treatment with cyclosporine (9) Serum CK (CKP) < 1,000 IU/L (10) Hypothyroidism, inherited myopathy or a history of drug-induced myopathy (11) Pregnant, breast-feeding, becoming pregnant (12) Inadequate to this study

Design outcomes

Primary

Measure	Time frame
Change rate of LDL-cholesterol from baseline	—

Secondary

Measure	Time frame
Change rate of total cholesterol, HDL-cholesterol, triglyceride,and non-HDL-cholesterol from baeline	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026