Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Kowa

Status and phase: Completed; Phase 3

Conditions: Type II Diabetes Mellitus; Dyslipidemia

Treatments: Drug: Atorvastatin; Drug: Pitavastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00344370

NK-104-310

Details and patient eligibility

About

This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.

Enrollment: 214 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type II diabetes mellitus
• Combined dyslipidemia
• Completed NK-104-305 (NCT00309751)

Exclusion criteria

• Withdrawal from NK-104-305 (NCT00309751)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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214 participants in 2 patient groups

Pitavastatin

Experimental group

Description:

Pitavastatin 4 mg QD

Treatment:

Drug: Pitavastatin

Atorvastatin

Active Comparator group

Description:

Atorvastatin 40 mg

Treatment:

Drug: Atorvastatin