CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 199 enrolled
Drug / intervention
Niacin ER/Simvastatin Tablets +1 moredrug
Likely dose
Niacin ER/Simvastatin Tablets 2000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00465088
NCT00465088Phase 3Completed
CompareCT.gov

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

Abbott·interventional·Posted Apr 24, 2007·Updated Jun 13, 2011

In Brief

A Phase 3 clinical trial evaluating Niacin ER/Simvastatin Tablets and atorvastatin for Hyperlipidemia and Mixed Dyslipidemia. Completed, enrolled 199 participants across 46 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia, Mixed Dyslipidemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 24, 2007
Enrollment StartApr 1, 2007
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.2 years ago

Interventions

Niacin ER/Simvastatin Tabletsdrug

Up to 2000 mg/40 mg at bedtime

atorvastatindrug

40 mg at bedtime