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)

June 9, 2011 updated by: Abbott

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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
    • 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
    • Georgia
      • Calhoun, Georgia, United States, 30701
      • Decatur, Georgia, United States, 30034
      • Dunwoody, Georgia, United States, 30338
    • Idaho
      • Boise, Idaho, United States, 83704
    • Illinois
      • Chicago, Illinois, United States, 60607
    • 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
    • Maine
      • Auburn, Maine, United States, 04210
    • Maryland
      • Baltimore, Maryland, United States, 21204
    • Montana
      • Missoula, Montana, United States, 59808
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • High Point, North Carolina, United States, 27262
    • Ohio
      • Canfield, Ohio, United States, 44406
      • Cincinnati, Ohio, United States, 45242
      • Dayton, Ohio, United States, 45458
    • Oregon
      • Protland, Oregon, United States, 97239
    • Pennsylvania
      • Chicora, Pennsylvania, United States, 16025
      • Duncansville, Pennsylvania, United States, 16635
      • Harleysville, Pennsylvania, United States, 19438
      • Pittsburgh, Pennsylvania, United States, 15206
    • 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
    • Utah
      • Magna, Utah, United States, 84044
      • Salt Lake City, Utah, United States, 84107
    • Virginia
      • Richmond, Virginia, United States, 23249
    • Washington
      • Gig Harbor, Washington, United States, 98335
    • Wisconsin
      • Menomonee Falls, Wisconsin, United States, 53051
      • Milwaukee, Wisconsin, United States, 53209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to Week 8
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
From baseline to Week 8
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
From baseline to Week 12
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
From baseline to Week 12
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
From baseline to Week 12
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
From baseline to Week 12
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
From baseline to Week 12
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
From baseline to Week 12
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
From baseline to Week 12
Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12
Time Frame: 12 weeks
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.
12 weeks
Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Roopal Thakkar, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

April 23, 2007

First Submitted That Met QC Criteria

April 23, 2007

First Posted (Estimate)

April 24, 2007

Study Record Updates

Last Update Posted (Estimate)

June 13, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 019-05-06-CR
  • M10-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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