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

This study has been completed.
Sponsor:
Information provided by:
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT00309751
First received: December 8, 2005
Last updated: February 17, 2010
Last verified: February 2010
Results First Received: August 26, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Type II Diabetes Mellitus
Dyslipidemia
Interventions: Drug: Pitavastatin
Drug: Atorvastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pitavastatin 4 mg QD Pitavastatin 4 mg once daily
Atorvastatin 20 mg QD Atorvastatin 20 mg once daily

Participant Flow:   Overall Study
    Pitavastatin 4 mg QD     Atorvastatin 20 mg QD  
STARTED     279     139  
Safety Population     275 [1]   137 [1]
COMPLETED     248     124  
NOT COMPLETED     31     15  
[1] Subjects who received at least 1 dose of study drug



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Pitavastatin 4 mg QD Pitavastatin 4 mg once daily
Atorvastatin 20 mg QD Atorvastatin 20 mg once daily
Total Total of all reporting groups

Baseline Measures
    Pitavastatin 4 mg QD     Atorvastatin 20 mg QD     Total  
Number of Participants  
[units: participants]
  275     137     412  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     191     93     284  
>=65 years     84     44     128  
Age  
[units: years]
Mean ± Standard Deviation
  59.1  ± 9.21     59.8  ± 9.06     59.4  ± 9.15  
Gender  
[units: participants]
     
Female     120     59     179  
Male     155     78     233  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Bill Arana
Organization: Kowa Research Institute Inc
phone: 919 433 1600
e-mail: barana@kowaus.com


No publications provided


Responsible Party: Dragos Budinski, MD, Kowa Research Europe
ClinicalTrials.gov Identifier: NCT00309751     History of Changes
Other Study ID Numbers: NK-104-305
Study First Received: December 8, 2005
Results First Received: August 26, 2009
Last Updated: February 17, 2010
Health Authority: Poland: Ministry of Health
Germany: Ethics Commission
India: Indian Council of Medical Research