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

Sponsor:	Kos Pharmaceuticals
Information provided by:	Kos Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00071266

Purpose

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.

Condition	Intervention	Phase
Intermittent Claudication Peripheral Vascular Disease	Drug: Niacin Extended Release and Lovastatin Tablets	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - a Matrix Design

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Niacin Lovastatin Niacinamide Niacin hydrochloride

U.S. FDA Resources

Further study details as provided by Kos Pharmaceuticals:

Estimated Enrollment:	870
Study Start Date:	October 2003

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071266

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Locations

United States, Arizona
Tatum Ridge Internal Medicine
Phoenix, Arizona, United States, 85032
Scottsdale Cardiovascular Research Institute, LLC
Scottsdale, Arizona, United States, 85251
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
North County Internal Medicine
Vista, California, United States, 92083
University of California-Davis; Department of Surgery
Sacramento, California, United States, 95819
Sacramento Heart & Vascular Medical Associates
Sacramento, California, United States, 95825
Clinical Research Center of California
San Diego, California, United States, 92103
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80200
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Florida
Cardiovascular Center of Sarasota
Sarasota, Florida, United States, 34239
United States, Georgia
Clinical Research Center of Georgia
Warner Robins, Georgia, United States, 31093
United States, Indiana
River Cities Cardiology, MPC
Jeffersonville, Indiana, United States, 47130
United States, Maryland
HPV Heart P.A.
Columbia, Maryland, United States, 21044
United States, Michigan
St. Joseph Mercy-Oakland Research Office
Pontiac, Michigan, United States, 48341
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
United States, North Carolina
Carolina Pharmaceutical Research
Statesville, North Carolina, United States, 28625
United States, Oklahoma
COR Clinical Research
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
New Hope Research of Oregon
Portland, Oregon, United States, 97219
United States, Pennsylvania
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Mainline Health Heart Center
Wynnewood, Pennsylvania, United States, 19096
Radiant Research
Philadelphia, Pennsylvania, United States, 19115
United States, Texas
Clinical Cardiology Research Center
Dallas, Texas, United States, 75246
Pro Research Group, LLC
San Antonio, Texas, United States, 78205
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Hampton Roads Center for Clinical Research, Inc.
Norfolk, Virginia, United States, 23502
United States, Wisconsin
Care Foundation, Inc
Wausau, Wisconsin, United States, 54401

Sponsors and Collaborators

Kos Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	MA-03-010401, The TROPIC Study
Study First Received:	October 16, 2003
Last Updated:	October 31, 2006
ClinicalTrials.gov Identifier:	NCT00071266 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kos Pharmaceuticals:

Intermittent Claudication
Peripheral Arterial Disease
Atherosclerosis
Niacin

Lovastatin
PAD
IC

Additional relevant MeSH terms:

Antimetabolites
Arterial Occlusive Diseases
Vasodilator Agents
Vitamin B Complex
Peripheral Vascular Diseases
Molecular Mechanisms of Pharmacological Action
Growth Substances
Antilipemic Agents
Physiological Effects of Drugs
Vascular Diseases
Enzyme Inhibitors
Anticholesteremic Agents

Arteriosclerosis
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Signs and Symptoms
Vitamins
Therapeutic Uses
Intermittent Claudication
Cardiovascular Diseases
Micronutrients
Niacin
Lovastatin

ClinicalTrials.gov processed this record on November 30, 2009