The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC
NCT ID: NCT00071266
Last Updated: 2006-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
870 participants
INTERVENTIONAL
2003-10-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Niacin Extended Release and Lovastatin Tablets
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
40 Years
ALL
No
Sponsors
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Kos Pharmaceuticals
INDUSTRY
Locations
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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
Care Foundation, Inc
Wausau, Wisconsin, United States
Countries
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Other Identifiers
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The TROPIC Study
Identifier Type: -
Identifier Source: secondary_id
MA-03-010401
Identifier Type: -
Identifier Source: org_study_id