NCT00465088

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: 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperlipidemia
• Mixed Dyslipidemia

Interventions

Type	Name	Description
DRUG	Niacin ER/Simvastatin Tablets	Up to 2000 mg/40 mg at bedtime
DRUG	atorvastatin	40 mg at bedtime

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-02-01
• First posted: 2007-04-24
• Last updated: 2011-06-13
• Results posted: 2009-05-13

Locations

46 sites across 1 country: United States