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

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.

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Key information

Conditions

Type II Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CCBR Aalborg, Aalborg, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Withdrawal from NK-104-305 (NCT00309751)

Treatment and study plan

Pitavastatin

Drug

Pitavastatin 4 mg QD

Other names: Livalo

atorvastatin

Drug

Atorvastatin 40 mg

Other names: Lipitor

Primary outcomes

NCEP LDL-C Target Attainment

Time frame: 44 weeks

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.

Secondary outcomes

Percent Change From Baseline in LDL-C

Time frame: Basseline to 44 weeks

Percent change from baseline in LDL-C at 44 weeks

Sponsors and collaborators

Lead sponsor

Kowa Research Europe

Industry

Registry information

Official study title

Double-Blind, Follow-On Study of Pitavastatin (4 mg) Versus Atorvastatin (20 mg and 40 mg), With a Single-Blind Extension of Treatment, in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jun 26, 2006
Registry last updated: Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed