An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00465088
First received: April 23, 2007
Last updated: June 9, 2011
Last verified: June 2011
Results First Received: February 10, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hyperlipidemia
Mixed Dyslipidemia
Interventions: Drug: Niacin ER/Simvastatin Tablets
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 199 subjects randomized, 6 did not receive study drug: 2 withdrew consent, 1 had a protocol violation, and 3 had randomization errors. 193 subjects were treated.

Reporting Groups
  Description
Niacin Extended-release Plus Simvastatin Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
Atorvastatin 40 mg atorvastatin once daily at bedtime

Participant Flow:   Overall Study
    Niacin Extended-release Plus Simvastatin     Atorvastatin  
STARTED     114 [1]   79  
COMPLETED     82     70  
NOT COMPLETED     32     9  
[1] For both arms, started means treated.



  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
Niacin Extended-release Plus Simvastatin Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
Atorvastatin 40 mg atorvastatin once daily at bedtime
Total Total of all reporting groups

Baseline Measures
    Niacin Extended-release Plus Simvastatin     Atorvastatin     Total  
Number of Participants  
[units: participants]
  114     79     193  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     93     73     166  
>=65 years     21     6     27  
Age  
[units: years]
Mean ± Standard Deviation
  55.1  ± 12.06     51.5  ± 11.12     53.6  ± 11.80  
Gender  
[units: participants]
     
Female     71     38     109  
Male     43     41     84  
Region of Enrollment  
[units: participants]
     
United States     114     79     193  



  Outcome Measures
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1.  Primary:   Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12   [ Time Frame: From baseline to Week 12 ]

2.  Secondary:   Percent Change in HDL-C From Baseline to Week 8   [ Time Frame: From baseline to Week 8 ]

3.  Secondary:   Percent Change in Non-HDL-C From Baseline to Week 8   [ Time Frame: From baseline to Week 8 ]

4.  Secondary:   Percent Change in Non-HDL-C From Baseline to Week 12   [ Time Frame: From baseline to Week 12 ]

5.  Secondary:   Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12   [ Time Frame: From baseline to Week 12 ]

6.  Secondary:   Percent Change in Triglycerides From Baseline to Week 12   [ Time Frame: From baseline to Week 12 ]

7.  Secondary:   Percent Change in LDL-C:HDL-C Ratio   [ Time Frame: From baseline to Week 12 ]

8.  Secondary:   Percent Change in Total Cholesterol From Baseline to Week 12   [ Time Frame: From baseline to Week 12 ]

9.  Secondary:   Percent Change in Total Cholesterol:HDL-C Ratio   [ Time Frame: From baseline to Week 12 ]

10.  Secondary:   Percent Change in Lipoprotein A From Baseline to Week 12   [ Time Frame: From baseline to Week 12 ]

11.  Secondary:   Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12   [ Time Frame: 12 weeks ]

12.  Secondary:   Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12   [ Time Frame: 12 weeks ]

13.  Secondary:   Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12   [ Time Frame: 12 weeks ]

14.  Secondary:   Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12   [ Time Frame: 12 weeks ]


  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: Global Medical Services
Organization: Abbott
phone: 800-633-9110


No publications provided


Responsible Party: Scott Krause, AD Clinical Research, Abbott
ClinicalTrials.gov Identifier: NCT00465088     History of Changes
Other Study ID Numbers: 019-05-06-CR, M10-013
Study First Received: April 23, 2007
Results First Received: February 10, 2009
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration