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Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
This study has been completed.
Study NCT00309738   Information provided by Kowa Research Europe

First Received on December 8, 2005.   Last Updated on March 9, 2010   History of Changes
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: Hypercholesterolemia
Dyslipidemia
Interventions: Drug: pitavastatin
Drug: simvastatin

  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
Subjects were enrolled from September 2005 to October 2006 at 43 investigator sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who qualified entered a 6-8 week wash-out/dietary lead-in period followed by a 12- week treatment period. Patients were randomly assigned to one of the two treatment groups: pitavastatin 4 mg QD, or simvastatin 40 mg QD in a ratio of 2:1.

Reporting Groups
  Description
Pitavastatin 4 mg QD Pitavastatin 4 mg once daily
Simvastatin 40 mg QD Simvastatin 40 mg once daily

Participant Flow:   Overall Study
    Pitavastatin 4 mg QD     Simvastatin 40 mg QD  
STARTED     236     119  
Safety Population     233 [1]   119 [1]
COMPLETED     223     107  
NOT COMPLETED     13     12  
[1] Subjects who received at least one dose of study medication



  Baseline Characteristics
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Reporting Groups
  Description
Pitavastatin 4 mg QD Pitavastatin 4 mg once daily
Simvastatin 40 mg QD Simvastatin 40 mg once daily

Baseline Measures
    Pitavastatin 4 mg QD     Simvastatin 40 mg QD     Total  
Number of Participants  
[units: participants]
  233     119     352  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     184     88     272  
>=65 years     49     31     80  
Age  
[units: years]
Mean ± Standard Deviation
  60.1  ± 6.82     60.9  ± 6.78     60.3  ± 6.81  
Gender  
[units: participants]
     
Female     75     37     112  
Male     158     82     240  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in LDL-C   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)   [ Time Frame: 12 weeks ]


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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


No publications provided by Kowa Research Europe

Publications automatically indexed to this study:

Responsible Party: Neil Hounslow, Kowa Research Europe
ClinicalTrials.gov Identifier: NCT00309738     History of Changes
Other Study ID Numbers: NK-104-304
Study First Received: December 8, 2005
Results First Received: August 26, 2009
Last Updated: March 9, 2010
Health Authority: Sweden: Medical Products Agency;   Spain: Spanish Agency of Medicines