Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication

Summary

The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses, compared to diet control (this group will receive a tablet containing 50 mg. of immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused by a narrowing of their leg arteries, a condition called intermittent claudication. At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study. Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration) approved cholesterol modifying medications: Niaspan® (extended-release niacin) and lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational. An investigational use is one that is not approved by the FDA.

Timeline

Start

2003-01

Primary completion

—

Completion

2006-03

Publications

• Hiatt WR, Hirsch AT, Creager MA, Rajagopalan S, Mohler ER, Ballantyne CM, Regensteiner JG, Treat-Jacobson D, Dale RA, Rooke T. Effect of niacin ER/lovastatin on claudication symptoms in patients with peripheral artery disease. Vasc Med. 2010 Jun;15(3):171-9. doi: 10.1177/1358863X09360579. Epub 2010 Mar 8.

Drugs

Indications