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)

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2008

Interventions

  • Drug: Niacin ER/Simvastatin Tablets
    • Up to 2000 mg/40 mg at bedtime
  • Drug: atorvastatin
    • 40 mg at bedtime

Arms, Groups and Cohorts

  • Experimental: 1
  • Experimental: 2

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12
    • Time Frame: 12 weeks
  • 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.
  • Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12
    • Time Frame: 12 weeks
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott
  • Provider of Information About this Clinical Study
    • Scott Krause, AD Clinical Research, Abbott
  • Overall Official(s)
    • Roopal Thakkar, MD, Study Director, Abbott

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