An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin

Phase 4 Completed 17 enrolled Provident Clinical Research Reliant Pharmaceuticals · collab

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this trial is to assess the continued efficacy of Omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HCL-C) levels.

Timeline

Start: 2007-08
Primary completion: 2009-08
Completion: 2009-09

Outcome

Met primary endpoint

registry analysis (superiority test); Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day.; p = 0.0008; ANOVA; note: Threshold for statistical significance p\<0.05 NCT00678743 ↗

Publications

Maki KC, Lawless AL, Kelley KM, Dicklin MR, Kaden VN, Schild AL, Rains TM, Marshall JW. Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia. J Cardiovasc Pharmacol. 2011 Apr;57(4):489-94. doi: 10.1097/FJC.0b013e318210fca5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lovaza	Other / unclassified	4 g	—
Subject	Simvastatin	Small molecule	80 mg	—