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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) (SUPREME)

Primary Purpose

Hyperlipidemia, Mixed Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Niacin ER/Simvastatin Tablets
atorvastatin
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12
(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
(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
Percent Change in Non-HDL-C 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
(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
(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C
Percent Change in Triglycerides From Baseline to Week 12
(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides
Percent Change in LDL-C:HDL-C Ratio
(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
(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol
Percent Change in Total Cholesterol:HDL-C Ratio
(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
(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
Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12
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
Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12
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.

Full Information

First Posted
April 23, 2007
Last Updated
June 9, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00465088
Brief Title
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)
Acronym
SUPREME
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Mixed Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Niacin ER/Simvastatin Tablets
Other Intervention Name(s)
ABT-919/483, Niacin ER/Simvastatin, Simcor
Intervention Description
Up to 2000 mg/40 mg at bedtime
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
40 mg at bedtime
Primary Outcome Measure Information:
Title
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12
Description
(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
Time Frame
From baseline to Week 12
Secondary Outcome Measure Information:
Title
Percent Change in HDL-C From Baseline to Week 8
Description
(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
Time Frame
From baseline to Week 8
Title
Percent Change in Non-HDL-C From Baseline to Week 8
Description
(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C
Time Frame
From baseline to Week 8
Title
Percent Change in Non-HDL-C From Baseline to Week 12
Description
(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C
Time Frame
From baseline to Week 12
Title
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12
Description
(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C
Time Frame
From baseline to Week 12
Title
Percent Change in Triglycerides From Baseline to Week 12
Description
(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides
Time Frame
From baseline to Week 12
Title
Percent Change in LDL-C:HDL-C Ratio
Description
(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio
Time Frame
From baseline to Week 12
Title
Percent Change in Total Cholesterol From Baseline to Week 12
Description
(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol
Time Frame
From baseline to Week 12
Title
Percent Change in Total Cholesterol:HDL-C Ratio
Description
(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio
Time Frame
From baseline to Week 12
Title
Percent Change in Lipoprotein A From Baseline to Week 12
Description
(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A
Time Frame
From baseline to Week 12
Title
Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12
Time Frame
12 weeks
Title
Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12
Description
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.
Time Frame
12 weeks
Title
Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12
Time Frame
12 weeks
Title
Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roopal Thakkar, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32953
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
City
Calhoun
State/Province
Georgia
ZIP/Postal Code
30701
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
Country
United States
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66216
Country
United States
City
Topeka
State/Province
Kansas
ZIP/Postal Code
55508
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Canfield
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45458
Country
United States
City
Protland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Chicora
State/Province
Pennsylvania
ZIP/Postal Code
16025
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
City
Magna
State/Province
Utah
ZIP/Postal Code
84044
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98335
Country
United States
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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)

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