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

Information source: Kos Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intermittent Claudication; Peripheral Vascular Disease

Intervention: Niacin Extended Release and Lovastatin Tablets (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Kos Pharmaceuticals

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 ā€œintermittent claudicationā€ (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.

Clinical Details

Official title: The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - a Matrix Design

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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 ā‰„ 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 ā‰„160 mmHg &/or diastolic blood pressure ā‰„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.

Locations and Contacts

Tatum Ridge Internal Medicine, Phoenix, Arizona 85032, United States

Scottsdale Cardiovascular Research Institute, LLC, Scottsdale, Arizona 85251, United States

VA Palo Alto Health Care System, Palo Alto, California 94304, United States

Sacramento Heart & Vascular Medical Associates, Sacramento, California 95825, United States

University of California-Davis; Department of Surgery, Sacramento, California 95819, United States

Clinical Research Center of California, San Diego, California 92103, United States

North County Internal Medicine, Vista, California 92083, United States

University of Colorado Health Sciences Center, Denver, Colorado 80200, United States

University of Connecticut Health Center, Farmington, Connecticut 06030, United States

Cardiovascular Center of Sarasota, Sarasota, Florida 34239, United States

Clinical Research Center of Georgia, Warner Robins, Georgia 31093, United States

River Cities Cardiology, MPC, Jeffersonville, Indiana 47130, United States

HPV Heart P.A., Columbia, Maryland 21044, United States

St. Joseph Mercy-Oakland Research Office, Pontiac, Michigan 48341, United States

Saint Louis University, Saint Louis, Missouri 63104, United States

Carolina Pharmaceutical Research, Statesville, North Carolina 28625, United States

COR Clinical Research, Oklahoma City, Oklahoma 73104, United States

New Hope Research of Oregon, Portland, Oregon 97219, United States

Penn State College of Medicine, Hershey, Pennsylvania 17033, United States

Radiant Research, Philadelphia, Pennsylvania 19115, United States

Mainline Health Heart Center, Wynnewood, Pennsylvania 19096, United States

Clinical Cardiology Research Center, Dallas, Texas 75246, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Pro Research Group, LLC, San Antonio, Texas 78205, United States

Hampton Roads Center for Clinical Research, Inc., Norfolk, Virginia 23502, United States

Care Foundation, Inc, Wausau, Wisconsin 54401, United States

Additional Information

Starting date: October 2003
Last updated: October 31, 2006

Page last updated: August 23, 2015

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