The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC
- Conditions
- Intermittent ClaudicationPeripheral Vascular Disease
- Registration Number
- NCT00071266
- Lead Sponsor
- Kos Pharmaceuticals
- Brief 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.
- Detailed Description
This is a Phase 3, 32-week, double-blind, diet-intervention, randomized, parallel group, ten-arm, multi-center, multi-national, dose titration study evaluating the safety and efficacy of NL in patients with intermittent claudication (IC).
The objectives of this study are to evaluate the safety and efficacy of NL in patients with IC. The primary efficacy analysis will be the percent change from baseline in Peak Walking Time (PWT) calculated from the natural logarithm of the ratio of the time walked on treadmill at the Week 32 Visit divided by the time walked at baseline. Other efficacy measures will include Claudication Onset Time (COT) percent changes from baseline to Week 32 , changes in Ankle Brachial Index (ABI), Quality of Life (QoL) percent changes at Weeks 20 and 32, lower limb amputations, composite of cardiovascular events (MI, stroke, and vascular death), and coronary and peripheral artery revascularizations. Safety variables will include serum transaminases, routine chemistry parameters, hematology, and adverse events. Pharmacokinetic analyses will be conducted as well.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 870
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Tatum Ridge Internal Medicine
🇺🇸Phoenix, Arizona, United States
Scottsdale Cardiovascular Research Institute, LLC
🇺🇸Scottsdale, Arizona, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
University of California-Davis; Department of Surgery
🇺🇸Sacramento, California, United States
Sacramento Heart & Vascular Medical Associates
🇺🇸Sacramento, California, United States
Clinical Research Center of California
🇺🇸San Diego, California, United States
North County Internal Medicine
🇺🇸Vista, California, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Cardiovascular Center of Sarasota
🇺🇸Sarasota, Florida, United States
Scroll for more (16 remaining)Tatum Ridge Internal Medicine🇺🇸Phoenix, Arizona, United States