A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

This study has been completed.
Sponsor:
Collaborators:
Kowa Pharmaceuticals America, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01301066
First received: February 18, 2011
Last updated: March 27, 2014
Last verified: March 2014
Results First Received: February 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Dyslipidemia
Interventions: Drug: Pitavastatin
Drug: Pravastatin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pitavastatin 4 mg QD Pitavastatin: Pitavastatin 4 mg QD
Pravastatin 40 mg QD Pravastatin: Pravastatin 40 mg QD

Participant Flow:   Overall Study
    Pitavastatin 4 mg QD     Pravastatin 40 mg QD  
STARTED     126     126  
COMPLETED     99     91  
NOT COMPLETED     27     35  
Lost to Follow-up                 5                 11  
Protocol Violation                 8                 7  
Withdrawal by Subject                 4                 9  
Adverse Event                 6                 6  
Sponsor Decision                 2                 1  
Physician Decision                 0                 1  
Other                 2                 0  



  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: Pitavastatin 4 mg QD
Pravastatin 40 mg QD Pravastatin: Pravastatin 40 mg QD
Total Total of all reporting groups

Baseline Measures
    Pitavastatin 4 mg QD     Pravastatin 40 mg QD     Total  
Number of Participants  
[units: participants]
  126     126     252  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     126     126     252  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     20     15     35  
Male     106     111     217  
Region of Enrollment  
[units: participants]
     
United States     126     126     252  



  Outcome Measures

1.  Primary:   Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks   [ Time Frame: 12 weeks minus baseline ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Pitavastatin 4 mg QD Pitavastatin: Pitavastatin 4 mg QD
Pravastatin 40 mg QD Pravastatin: Pravastatin 40 mg QD

Serious Adverse Events
    Pitavastatin 4 mg QD     Pravastatin 40 mg QD  
Total, serious adverse events      
# participants affected / at risk     7/126 (5.56%)     3/126 (2.38%)  
Cardiac disorders      
Arteriosclerosis coronary artery      
# participants affected / at risk     0/126 (0.00%)     1/126 (0.79%)  
# events     0     1  
Atrial septal defect      
# participants affected / at risk     1/126 (0.79%)     0/126 (0.00%)  
# events     1     0  
Chest pain      
# participants affected / at risk     1/126 (0.79%)     0/126 (0.00%)  
# events     1     0  
Myocardial infarction      
# participants affected / at risk     0/126 (0.00%)     1/126 (0.79%)  
# events     0     1  
Gastrointestinal disorders      
Diverticulitis      
# participants affected / at risk     1/126 (0.79%)     0/126 (0.00%)  
# events     1     0  
Enterovesical fistula      
# participants affected / at risk     1/126 (0.79%)     0/126 (0.00%)  
# events     1     0  
Gastroenteritis      
# participants affected / at risk     1/126 (0.79%)     0/126 (0.00%)  
# events     1     0  
Gastroenteritis viral      
# participants affected / at risk     1/126 (0.79%)     0/126 (0.00%)  
# events     1     0  
Infections and infestations      
Herpes dermatitis      
# participants affected / at risk     1/126 (0.79%)     0/126 (0.00%)  
# events     1     0  
Musculoskeletal and connective tissue disorders      
Multiple fractures      
# participants affected / at risk     1/126 (0.79%)     0/126 (0.00%)  
# events     1     0  
Muscle haemorrhage      
# participants affected / at risk     0/126 (0.00%)     1/126 (0.79%)  
# events     0     1  
Nervous system disorders      
Cerebrovascular accident      
# participants affected / at risk     0/126 (0.00%)     1/126 (0.79%)  
# events     0     1  
Respiratory, thoracic and mediastinal disorders      
Chronic obstructive pulmonary disease      
# participants affected / at risk     1/126 (0.79%)     0/126 (0.00%)  
# events     1     0  
Respiratory failure      
# participants affected / at risk     1/126 (0.79%)     0/126 (0.00%)  
# events     1     0  
Vascular disorders      
Transient ischaemic attack      
# participants affected / at risk     1/126 (0.79%)     0/126 (0.00%)  
# events     1     0  




  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Roger Morgan, MD, FACS
Organization: Kowa Research Institute, Inc.
phone: 919-433-1600
e-mail: RMorgan@kowaus.com


No publications provided


Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01301066     History of Changes
Other Study ID Numbers: NK-104-4.05US
Study First Received: February 18, 2011
Results First Received: February 10, 2014
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration