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Completed

NCT Number: NCT00465088

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)

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Mixed Dyslipidemia Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Niacin ER/Simvastatin Tablets

Drug

Up to 2000 mg/40 mg at bedtime

Other names: ABT-919/483, Niacin ER/Simvastatin, Simcor

atorvastatin

Drug

40 mg at bedtime

Primary outcomes

  1. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12

    Time frame: From baseline to Week 12

    (Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

Secondary outcomes

  1. Percent Change in HDL-C From Baseline to Week 8

    Time frame: From baseline to Week 8

    (Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

  2. Percent Change in Non-HDL-C From Baseline to Week 8

    Time frame: From baseline to Week 8

    (Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

  3. Percent Change in Non-HDL-C From Baseline to Week 12

    Time frame: From baseline to Week 12

    (Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

  4. Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12

    Time frame: From baseline to Week 12

    (Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C

  5. Percent Change in Triglycerides From Baseline to Week 12

    Time frame: From baseline to Week 12

    (Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides

  6. Percent Change in LDL-C:HDL-C Ratio

    Time frame: From baseline to Week 12

    (Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio

  7. Percent Change in Total Cholesterol From Baseline to Week 12

    Time frame: From baseline to Week 12

    (Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol

  8. Percent Change in Total Cholesterol:HDL-C Ratio

    Time frame: From baseline to Week 12

    (Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio

  9. Percent Change in Lipoprotein A From Baseline to Week 12

    Time frame: From baseline to Week 12

    (Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A

  10. Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12

    Time frame: 12 weeks

  11. 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

    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.

  12. Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12

    Time frame: 12 weeks

  13. 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

    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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Acronym: SUPREME

Important dates

Study start
2007
Primary completion
2008
First posted
Apr 24, 2007
Registry last updated
Jun 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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