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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Mixed Dyslipidemia
 Drug: Niacin ER/Simvastatin Tablets
Drug: atorvastatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 199
Study Start Date: April 2007
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Niacin ER/Simvastatin Tablets
Up to 2000 mg/40 mg at bedtime
Other Names:
  • ABT-919/483
  • Niacin ER/Simvastatin
  • Simcor
Experimental: 2 Drug: atorvastatin
40 mg at bedtime
Other Name: atorvastatin

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465088

  Show 46 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Roopal Thakkar, MD Abbott
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Simvastatin
Atorvastatin
Nicotinic Acids
Niacinamide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013