Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia (PREVAIL-US)

Kowa

Status and phase: Completed; Phase 4

Conditions: Mixed Dyslipidemia; Primary Dyslipidemia

Treatments: Drug: pitavastatin; Drug: pravastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01256476

NK-104-4.04US

Details and patient eligibility

About

Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.

Enrollment: 328 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent
• Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL

Exclusion criteria

• Homozygous familial hypercholesterolemia
• Any conditions which may cause secondary dyslipidemia
• Uncontrolled diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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328 participants in 2 patient groups

pitavastatin 4 mg once daily (QD)

Experimental group

Treatment:

Drug: pitavastatin

pravastatin 40 mg once daily (QD)

Active Comparator group

Treatment:

Drug: pravastatin