Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00435045
First received: February 13, 2007
Last updated: September 3, 2010
Last verified: September 2010
Results First Received: October 22, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Hypertriglyceridemia
Interventions: Drug: Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin
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
No text entered.

Reporting Groups
  Description
Lovaza(Omacor) + Atorvastatin Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
Placebo + Atorvastatin Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.

Participant Flow for 3 periods

Period 1:   Weeks 1-8 / 10 mg Dose Level
    Lovaza(Omacor) + Atorvastatin     Placebo + Atorvastatin  
STARTED     123     122  
COMPLETED     118     118  
NOT COMPLETED     5     4  
Adverse Event                 1                 1  
Lost to Follow-up                 1                 1  
Withdrawal by Subject                 2                 1  
Family Crisis - could not participate                 1                 0  
Requirement for Excluded Medications                 0                 1  

Period 2:   Weeks 9-12 / 20mg Dose Level
    Lovaza(Omacor) + Atorvastatin     Placebo + Atorvastatin  
STARTED     118     118  
COMPLETED     113     113  
NOT COMPLETED     5     5  
Adverse Event                 4                 3  
Lost to Follow-up                 1                 1  
Withdrawal by Subject                 0                 1  

Period 3:   Weeks 13-16 / 40mg Dose Level
    Lovaza(Omacor) + Atorvastatin     Placebo + Atorvastatin  
STARTED     113     113  
COMPLETED     108     111  
NOT COMPLETED     5     2  
Adverse Event                 3                 2  
Withdrawal by Subject                 1                 0  
Per Sponsors Request                 1                 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.
No text entered.

Reporting Groups
  Description
Lovaza(Omacor) + Atorvastatin Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
Placebo + Atorvastatin Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
Total Total of all reporting groups

Baseline Measures
    Lovaza(Omacor) + Atorvastatin     Placebo + Atorvastatin     Total  
Number of Participants  
[units: participants]
  123     122     245  
Age  
[units: years]
Mean ± Standard Deviation
  56.3  ± 9.64     56.0  ± 10.84     56.1  ± 10.23  
Gender  
[units: participants]
     
Female     52     51     103  
Male     71     71     142  
Race/Ethnicity, Customized  
[units: participants]
     
White     108     110     218  
Black or African American     6     4     10  
Asian     8     4     12  
American Indian or Alaskan Native     0     1     1  
Native Hawaiian or Pacific Islander     0     1     1  
Non-white     1     2     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

3.  Secondary:   Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

4.  Secondary:   Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

5.  Secondary:   Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

6.  Secondary:   Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

7.  Secondary:   Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

8.  Secondary:   Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

9.  Secondary:   Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

10.  Secondary:   Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

11.  Secondary:   Percent Change in Docosahexaenoic Acid (DHA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

12.  Secondary:   Percent Change in Eicosapentaenoic Acid (EPA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

13.  Secondary:   Percent Change in Low Density Lipoprotein Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

14.  Secondary:   Percent Change in Low Density Lipoprotein Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

15.  Secondary:   Percent Change in Lipoprotein-Phosphoslipase A2 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

16.  Secondary:   Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

17.  Secondary:   Percent Change in High Density Lipoprotein (HDL) Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

18.  Secondary:   Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

19.  Secondary:   Percent Change in Very Low Density Lipoproteins Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

20.  Secondary:   Percent Change in Intermediate Density Lipoprotein Particle Concentration From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

21.  Secondary:   Percent Change in Remnant-like Particle Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

22.  Secondary:   Percent Change in Total Adiponectin From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]

23.  Secondary:   Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 12 During 20 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 12 ]

24.  Secondary:   Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 16 During 40 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 16 ]

25.  Post-Hoc:   Percent Change in Apolipoprotein-B From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period   [ Time Frame: Baseline and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Publications automatically indexed to this study:

ClinicalTrials.gov Identifier: NCT00435045     History of Changes
Other Study ID Numbers: OM9L, LOV111819
Study First Received: February 13, 2007
Results First Received: October 22, 2008
Last Updated: September 3, 2010
Health Authority: United States: Food and Drug Administration