drugset / Trial / 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)

NCT00465088

Phase 3 Completed 199 enrolled Abbott
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-04
Primary completion
2008-02
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 40 mg
Subject Niacin Small molecule 2000 mg
Subject Simvastatin Small molecule 40 mg