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

Completed · Phase 3

Conditions studied: Intermittent Claudication, Peripheral Vascular Disease

In brief

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.

Key facts

Study ID

NCT00071266

Run by

Kos Pharmaceuticals

People needed

870

Starts

2003-10-01

Last updated by the study team

2006-11-02

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men \& women at least 40 years of age or older. Women must not be pregnant nor breast-feeding \& not planning to become pregnant or to breast-feed.
• History of IC of the lower extremities which has been present for at least 6 months with no change in symptoms in the previous 3 months prior to screening.
• LDL-C of <160 mg/dL and Triglycerides <800.

You may not qualify if…

• Severe neuropathy.
• Gross obesity (BMI ≥ 40).
• Presence of critical limb ischemia defined as ischemic rest pain, gangrene, ulceration, or pending amputation of a lower extremity due to severe PAD.
• Surgical intervention to alleviate symptoms of claudication within 6 months or endovascular interventions within 3 months.
• Documented CAD taking any cholesterol-modifying agent and unable to undergo washout as judged by the Investigator or due to personal choice.
• Systolic blood pressure ≥160 mmHg \&/or diastolic blood pressure ≥95 mmHg.
• Presence of clinically significant laboratory test abnormalities for liver or renal function tests, thyroid function or HgbA1C.
• History of alcohol abuse or currently drinks alcohol in excess.

Where it is running

• 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
• Clinical Research Center of Georgia — Warner Robins, Georgia, United States
• River Cities Cardiology, MPC — Jeffersonville, Indiana, United States
• HPV Heart P.A. — Columbia, Maryland, United States
• St. Joseph Mercy-Oakland Research Office — Pontiac, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Carolina Pharmaceutical Research — Statesville, North Carolina, United States
• COR Clinical Research — Oklahoma City, Oklahoma, United States
• New Hope Research of Oregon — Portland, Oregon, United States
• Penn State College of Medicine — Hershey, Pennsylvania, United States
• Radiant Research — Philadelphia, Pennsylvania, United States
• Mainline Health Heart Center — Wynnewood, Pennsylvania, United States
• Clinical Cardiology Research Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Pro Research Group, LLC — San Antonio, Texas, United States
• Hampton Roads Center for Clinical Research, Inc. — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.