Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
Anaheim, California, United States, 92801
Huntington Park, California, United States, 90255
Long Beach, California, United States, 90822
Sacramento, California, United States, 95825
Walnut Creek, California, United States, 94598
United States, Florida
Brooksville, Florida, United States, 34613
Daytona Beach, Florida, United States, 32117
Gainesville, Florida, United States, 32605
Largo, Florida, United States, 33770
Merritt Island, Florida, United States, 32953
Miami, Florida, United States, 33126
Pembroke Pines, Florida, United States, 33026
United States, Georgia
Calhoun, Georgia, United States, 30701
Decatur, Georgia, United States, 30034
Dunwoody, Georgia, United States, 30338
United States, Idaho
Boise, Idaho, United States, 83704
United States, Illinois
Chicago, Illinois, United States, 60607
United States, Kansas
Arkansas City, Kansas, United States, 67005
Newton, Kansas, United States, 67114
Shawnee Mission, Kansas, United States, 66216
Topeka, Kansas, United States, 55508
Wichita, Kansas, United States, 67203
United States, Maine
Auburn, Maine, United States, 04210
United States, Maryland
Baltimore, Maryland, United States, 21204
United States, Montana
Missoula, Montana, United States, 59808
United States, North Carolina
Charlotte, North Carolina, United States, 28204
High Point, North Carolina, United States, 27262
United States, Ohio
Canfield, Ohio, United States, 44406
Cincinnati, Ohio, United States, 45242
Dayton, Ohio, United States, 45458
United States, Oregon
Protland, Oregon, United States, 97239
United States, Pennsylvania
Chicora, Pennsylvania, United States, 16025
Duncansville, Pennsylvania, United States, 16635
Harleysville, Pennsylvania, United States, 19438
Pittsburgh, Pennsylvania, United States, 15206
United States, Texas
Austin, Texas, United States, 78752
Carrollton, Texas, United States, 75006
Dallas, Texas, United States, 75251
Houston, Texas, United States, 77074
San Antonio, Texas, United States, 78224
United States, Utah
Magna, Utah, United States, 84044
Salt Lake City, Utah, United States, 84107
United States, Virginia
Richmond, Virginia, United States, 23249
United States, Washington
Gig Harbor, Washington, United States, 98335
United States, Wisconsin
Menomonee Falls, Wisconsin, United States, 53051
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Abbott
Investigators
Study Director: Roopal Thakkar, MD Abbott
  More Information

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

ClinicalTrials.gov processed this record on November 24, 2014