The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC

Phase 3

Completed

• Conditions: Intermittent Claudication; Peripheral 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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2003-10-16
• Study First Submitted QC: 2003-10-17
• Study First Posted: 2003-10-20
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-31
• Last Update Posted: 2006-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 870

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (26)

Penn State College of Medicine; 🇺🇸 Hershey, Pennsylvania, United States

North County Internal Medicine; 🇺🇸 Vista, California, United States

Care Foundation, Inc; 🇺🇸 Wausau, Wisconsin, United States

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States

Sacramento Heart & Vascular Medical Associates; 🇺🇸 Sacramento, California, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

Hampton Roads Center for Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States

Clinical Research Center of Georgia; 🇺🇸 Warner Robins, Georgia, United States

Cardiovascular Center of Sarasota; 🇺🇸 Sarasota, Florida, United States

St. Joseph Mercy-Oakland Research Office; 🇺🇸 Pontiac, Michigan, United States

Tatum Ridge Internal Medicine; 🇺🇸 Phoenix, Arizona, United States

University of Colorado Health Sciences Center; 🇺🇸 Denver, Colorado, United States

Clinical Research Center of California; 🇺🇸 San Diego, California, United States

COR Clinical Research; 🇺🇸 Oklahoma City, Oklahoma, United States

New Hope Research of Oregon; 🇺🇸 Portland, Oregon, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Pro Research Group, LLC; 🇺🇸 San Antonio, Texas, United States

River Cities Cardiology, MPC; 🇺🇸 Jeffersonville, Indiana, United States

Carolina Pharmaceutical Research; 🇺🇸 Statesville, North Carolina, United States

Clinical Cardiology Research Center; 🇺🇸 Dallas, Texas, United States

University of California-Davis; Department of Surgery; 🇺🇸 Sacramento, California, United States

HPV Heart P.A.; 🇺🇸 Columbia, Maryland, United States

Mainline Health Heart Center; 🇺🇸 Wynnewood, Pennsylvania, United States

Scottsdale Cardiovascular Research Institute, LLC; 🇺🇸 Scottsdale, Arizona, United States

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States

Radiant Research; 🇺🇸 Philadelphia, Pennsylvania, United States