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
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
2 other identifiers
interventional
199
1 country
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 23, 2007
CompletedFirst Posted
Study publicly available on registry
April 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedResults Posted
Study results publicly available
May 13, 2009
CompletedJune 13, 2011
June 1, 2011
10 months
April 23, 2007
February 10, 2009
June 9, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
From baseline to Week 12
Secondary Outcomes (13)
Percent Change in HDL-C From Baseline to Week 8
From baseline to Week 8
Percent Change in Non-HDL-C From Baseline to Week 8
From baseline to Week 8
Percent Change in Non-HDL-C From Baseline to Week 12
From baseline to Week 12
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12
From baseline to Week 12
Percent Change in Triglycerides From Baseline to Week 12
From baseline to Week 12
- +8 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
Up to 2000 mg/40 mg at bedtime
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (46)
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Huntington Park, California, 90255, United States
Unknown Facility
Long Beach, California, 90822, United States
Unknown Facility
Sacramento, California, 95825, United States
Unknown Facility
Walnut Creek, California, 94598, United States
Unknown Facility
Brooksville, Florida, 34613, United States
Unknown Facility
Daytona Beach, Florida, 32117, United States
Unknown Facility
Gainesville, Florida, 32605, United States
Unknown Facility
Largo, Florida, 33770, United States
Unknown Facility
Merritt Island, Florida, 32953, United States
Unknown Facility
Miami, Florida, 33126, United States
Unknown Facility
Pembroke Pines, Florida, 33026, United States
Unknown Facility
Calhoun, Georgia, 30701, United States
Unknown Facility
Decatur, Georgia, 30034, United States
Unknown Facility
Dunwoody, Georgia, 30338, United States
Unknown Facility
Boise, Idaho, 83704, United States
Unknown Facility
Chicago, Illinois, 60607, United States
Unknown Facility
Arkansas City, Kansas, 67005, United States
Unknown Facility
Newton, Kansas, 67114, United States
Unknown Facility
Shawnee Mission, Kansas, 66216, United States
Unknown Facility
Topeka, Kansas, 55508, United States
Unknown Facility
Wichita, Kansas, 67203, United States
Unknown Facility
Auburn, Maine, 04210, United States
Unknown Facility
Baltimore, Maryland, 21204, United States
Unknown Facility
Missoula, Montana, 59808, United States
Unknown Facility
Charlotte, North Carolina, 28204, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Canfield, Ohio, 44406, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Dayton, Ohio, 45458, United States
Unknown Facility
Protland, Oregon, 97239, United States
Unknown Facility
Chicora, Pennsylvania, 16025, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Harleysville, Pennsylvania, 19438, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15206, United States
Unknown Facility
Austin, Texas, 78752, United States
Unknown Facility
Carrollton, Texas, 75006, United States
Unknown Facility
Dallas, Texas, 75251, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
San Antonio, Texas, 78224, United States
Unknown Facility
Magna, Utah, 84044, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
Richmond, Virginia, 23249, United States
Unknown Facility
Gig Harbor, Washington, 98335, United States
Unknown Facility
Menomonee Falls, Wisconsin, 53051, United States
Unknown Facility
Milwaukee, Wisconsin, 53209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Roopal Thakkar, MD
Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 23, 2007
First Posted
April 24, 2007
Study Start
April 1, 2007
Primary Completion
February 1, 2008
Last Updated
June 13, 2011
Results First Posted
May 13, 2009
Record last verified: 2011-06