The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin,
Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of
their leg arteries.
At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take
part in this study.
Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug
Administration (FDA) to treat high cholesterol. Niacin ER/Lovastatin (Advicor®), a
combination of these two drugs, is also approved by the FDA to treat high cholesterol. The
use of Niacin ER/Lovastatin to treat narrowing of leg arteries and relieve "intermittent
claudication" (leg pain caused by narrowing of the arteries in the leg) 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