Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication
Completed
Kos Pharmaceuticals
Phase 3
2003-01-01
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.
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