Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Kowa

Status and phase: Completed; Phase 3

Conditions: Dyslipidemias; Hypercholesterolemia

Treatments: Drug: Pitavastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00330876

NK-104-308EU

Details and patient eligibility

About

This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.

Full description

This was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study NK-104-306 and who met the inclusion/exclusion criteria. Patients who qualified started open-label treatment with pitavastatin 2 mg QD. The dose of pitavastatin could be increased to 4 mg QD after at least 8 weeks of treatment at 2 mg QD, in patients who failed to attain their LDL-C target.

Enrollment: 545 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 65 years of age
• Primary hypercholesterolemia
• Combined dyslipidemia
• Completed study NK-104-306 (NCT00257686)

Exclusion criteria

• Failed to complete study NK-104-306(NCT00257686)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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545 participants in 2 patient groups

Pitavastatin 2 mg QD

Experimental group

Description:

Pitavastatin 2 mg once daily

Treatment:

Drug: Pitavastatin

Pitavastatin 4 mg QD

Experimental group

Description:

Pitavastatin 4 mg once daily

Treatment:

Drug: Pitavastatin