Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

Summary

This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.

Timeline

Start

2007-07

Primary completion

2008-07

Completion

2008-10

Outcome

Met primary endpoint

registry p = 0.006; Median Difference (Final Values) -4.5 (95% CI -7.7 to -1.3) NCT00479388 ↗

Publications

• Results Shah S, Ceska R, Gil-Extremera B, Paolini JF, Giezek H, Vandormael K, Mao A, McCrary Sisk C, Maccubbin D. Efficacy and safety of extended-release niacin/laropiprant plus statin vs. doubling the dose of statin in patients with primary hypercholesterolaemia or mixed dyslipidaemia. Int J Clin Pract. 2010 May;64(6):727-38. doi: 10.1111/j.1742-1241.2010.02370.x.
• Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.
• Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x.

Drugs

Indications