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

April 23, 2007
June 9, 2011
April 2007
February 2008   (final data collection date for primary outcome measure)
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12 [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
The percent change in HDL-C from baseline to Week 12.
Complete list of historical versions of study NCT00465088 on ClinicalTrials.gov Archive Site
  • Percent Change in HDL-C From Baseline to Week 8 [ Time Frame: From baseline to Week 8 ] [ Designated as safety issue: No ]
    (Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
  • Percent Change in Non-HDL-C From Baseline to Week 8 [ Time Frame: From baseline to Week 8 ] [ Designated as safety issue: No ]
    (Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C
  • Percent Change in Non-HDL-C From Baseline to Week 12 [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
    (Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C
  • Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12 [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
    (Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C
  • Percent Change in Triglycerides From Baseline to Week 12 [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
    (Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides
  • Percent Change in LDL-C:HDL-C Ratio [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
    (Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio
  • Percent Change in Total Cholesterol From Baseline to Week 12 [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
    (Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol
  • Percent Change in Total Cholesterol:HDL-C Ratio [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
    (Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio
  • Percent Change in Lipoprotein A From Baseline to Week 12 [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
    (Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A
  • Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    For high-risk patients (coronary heart disease or equivalent), LDL-C < 100 mg/dL and non-HDL-C < 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C < 130 mg/dL and non-HDL-C < 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C < 160 mg/dL and non-HDL-C < 190 mg/dL.
  • Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C < 100 mg/dL; for moderate risk patients, LDL-C < 130 mg/dL; for low-risk patients: LDL-C < 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.
  • The percent changes from baseline to Week 8 in HDL-C
  • The percent change from baseline to Week 8 and Week 12 in non-HDL-C
  • LDL-C
  • Total-C
  • LDL-C:HDL-C ratio
  • Total-C:HDL-C ratio
  • TG
  • Lp(a)
Not Provided
Not Provided
 
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)
SUPREME: A 12-Week, Open-Label, Multicenter Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia

To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifying therapy. This was a prospective, randomized, open-label, blinded endpoint (PROBE) study.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperlipidemia
  • Mixed Dyslipidemia
  • Drug: Niacin ER/Simvastatin Tablets
    Up to 2000 mg/40 mg at bedtime
    Other Names:
    • ABT-919/483
    • Niacin ER/Simvastatin
    • Simcor
  • Drug: atorvastatin
    40 mg at bedtime
    Other Name: atorvastatin
  • Experimental: 1
    Intervention: Drug: Niacin ER/Simvastatin Tablets
  • Experimental: 2
    Intervention: Drug: atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
199
Not Provided
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must meet all of the following laboratory criteria:

    • HDL-C <40 mg/dL for men and <50 mg/dL for women.
    • LDL-C ≥130 mg/dL but <250 mg/dL.
    • TG <350 mg/dL.
    • Creatine phosphokinase (CPK) < 3 x upper limit of normal (ULN).
    • Alanine aminotransferase (ALT); serum glutamic pyruvic transaminase [SGPT] and aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase [SGOT] < 1.3 x ULN.
  • Subjects must also be reasonably compliant with the Therapeutic Lifestyle Changes (TLC) diet during the 4 to 5 week Screening Period prior to randomization (and be willing to comply for the duration of the study).

Exclusion Criteria:

  • Subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00465088
019-05-06-CR, M10-013
Not Provided
Scott Krause, AD Clinical Research, Abbott
Abbott
Not Provided
Study Director: Roopal Thakkar, MD Abbott
Abbott
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP