Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00344370
Recruitment Status : Completed
First Posted : June 26, 2006
Results First Posted : January 18, 2010
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
Kowa Research Europe

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percent Change From Baseline in LDL-C [ Time Frame: Basseline to 44 weeks ]
    Percent change from baseline in LDL-C at 44 weeks


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Withdrawal from NK-104-305 (NCT00309751)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00344370


Locations
Show Show 35 study locations
Sponsors and Collaborators
Kowa Research Europe
Investigators
Layout table for investigator information
Study Director: Dragos Budinski, MD Kowa Research Europe (KRE)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dragos Budinski, MD, Kowa Research Europe
ClinicalTrials.gov 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:
Pitavastatin
Type II Diabetes Mellitus
Combined Dyslipidemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Dyslipidemias
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Atorvastatin
 Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors