Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors

Kowa

Status and phase: Completed; Phase 3

Conditions: Coronary Heart Disease; Hypercholesterolemia; Dyslipidemia

Treatments: Drug: pitavastatin; Drug: simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00344175

NK-104-309

Details and patient eligibility

About

This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.

Full description

This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed NK-104-304 (NCT 00309738)
• Hypercholesterolemia or combined dyslipidemia
• 2 or more risk factors for coronary heart disease (CHD)

Exclusion criteria

• Withdrawn or terminated from NK-104-304 (00309738)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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178 participants in 2 patient groups

Pitavastatin 4 mg

Experimental group

Description:

Pitavastatin 4 mg once daily

Treatment:

Drug: pitavastatin

Simvastatin 40mg/80mg

Active Comparator group

Description:

Simvastatin 40 mg or 80 mg once daily

Treatment:

Drug: simvastatin