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Completed

NCT Number: NCT00309751

Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.

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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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CCBR Aalborg, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females (ages 18-75 years)
  • Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
  • Must have been following a restrictive diet
  • Diagnosis of combined dyslipidemia

Exclusion criteria

  • Homozygous familial hypercholesterolemia
  • Conditions which may cause secondary dyslipidemia
  • Uncontrolled diabetes mellitus
  • Abnormal pancreatic, liver, or renal function
  • Abnormal serum creatine kinase (CK) above the pre-specified level
  • Significant heart disease

Treatment and study plan

Pitavastatin

Drug

Pitavastatin 4 mg QD

atorvastatin

Drug

Atorvastatin 20 mg

Other names: Lipitor

Primary outcomes

  1. Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)

    Time frame: 12 weeks

    Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)

Secondary outcomes

  1. Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target

    Time frame: 12 weeks

    Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks

Sponsors and collaborators

Lead sponsor

Kowa Research Europe

Industry

Registry information

Official study title

Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Apr 3, 2006
Registry last updated
Feb 23, 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.

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