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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00344370
Recruitment Status : Completed
First Posted : June 26, 2006
Results First Posted : January 18, 2010
Last Update Posted : February 2, 2010
Information provided by:
Kowa Research Europe

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Dyslipidemia Drug: Pitavastatin Drug: Atorvastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pitavastatin
Pitavastatin 4 mg QD
Drug: Pitavastatin
Pitavastatin 4 mg QD
Other Name: Livalo

Active Comparator: Atorvastatin
Atorvastatin 40 mg
Drug: Atorvastatin
Atorvastatin 40 mg
Other Name: Lipitor

Primary Outcome Measures :
  1. NCEP LDL-C Target Attainment [ Time Frame: 44 weeks ]

Secondary Outcome Measures :
  1. Percent Change From Baseline in LDL-C [ Time Frame: Basseline to 44 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Withdrawal from NK-104-305 (NCT00309751)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00344370

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Sponsors and Collaborators
Kowa Research Europe
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Study Director: Dragos Budinski, MD Kowa Research Europe (KRE)

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Responsible Party: Dragos Budinski, MD, Kowa Research Europe Identifier: NCT00344370    
Other Study ID Numbers: NK-104-310
First Posted: June 26, 2006    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: February 2, 2010
Last Verified: January 2010
Keywords provided by Kowa Research Europe:
Type II Diabetes Mellitus
Combined Dyslipidemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors