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

Kowa Research Europe214 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

214

Conditions

Type II Diabetes Mellitus Dyslipidemia

Interventions

PitavastatinDRUG

Pitavastatin 4 mg QD

AtorvastatinDRUG

Atorvastatin 40 mg

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Type II diabetes mellitus * Combined dyslipidemia * Completed NK-104-305 (NCT00309751) Exclusion Criteria: * Withdrawal from NK-104-305 (NCT00309751)

Locations (35)

Outcomes

Primary Outcomes

NCEP LDL-C Target Attainment

Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.

Time frame: 44 weeks

Secondary Outcomes

Percent Change From Baseline in LDL-C

Percent change from baseline in LDL-C at 44 weeks

Time frame: Basseline to 44 weeks

Data from ClinicalTrials.gov

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CCBR Aalborg

Aalborg, Denmark

CCBR A/S

Vejle, Denmark

CCBR Vejle

Vejle, Denmark

Gemeinschaftspraxis am Bahnhof

Berlin-Spandau, Germany

Pharmakologisches Studienzentum Chemnitz

Chemnitz, Germany

Internistische Diabetische Schwerpunktpraxis Dr.

Frankfurt am Main, Germany

Internistische Gemeinschaftspraxis

Mainz, Germany

Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler

Messkirch, Germany

Bhagwan Mahaveer Jain Heart Centre

Bangalore, India

Sri Ramachandra Medical College Hospital

Chennai, India

...and 25 more locations