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)

Completed · Phase 3

Conditions studied: Hyperlipidemia, Mixed Dyslipidemia

In brief

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.

Key facts

Study ID

NCT00465088

Run by

Abbott

People needed

199

Starts

2007-04-01

Last updated by the study team

2011-06-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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).

You may not qualify if…

• Subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion

Where it is running

• Study site — Anaheim, California, United States
• Study site — Huntington Park, California, United States
• Study site — Long Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Brooksville, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Merritt Island, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Calhoun, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Dunwoody, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Arkansas City, Kansas, United States
• Study site — Newton, Kansas, United States
• Study site — Shawnee Mission, Kansas, United States
• Study site — Topeka, Kansas, United States
• Study site — Wichita, Kansas, United States
• Study site — Auburn, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Missoula, Montana, United States

Full record on ClinicalTrials.gov

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