Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication
Status:
Completed
Trial end date:
2006-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Kos Pharmaceuticals
Treatments:
Dihydromevinolin L 647318 Lovastatin Niacin Niacinamide Nicotinic Acids