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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00071266
Other study ID # MA-03-010401
Secondary ID The TROPIC Study
Status Completed
Phase Phase 3
First received October 16, 2003
Last updated October 31, 2006
Start date October 2003

Study information

Verified date October 2006
Source Kos Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 870
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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.

Study Design

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


Intervention

Drug:
Niacin Extended Release and Lovastatin Tablets


Locations

Country Name City State
United States HPV Heart P.A. Columbia Maryland
United States Clinical Cardiology Research Center Dallas Texas
United States University of Colorado Health Sciences Center Denver Colorado
United States University of Connecticut Health Center Farmington Connecticut
United States Penn State College of Medicine Hershey Pennsylvania
United States Baylor College of Medicine Houston Texas
United States River Cities Cardiology, MPC Jeffersonville Indiana
United States Hampton Roads Center for Clinical Research, Inc. Norfolk Virginia
United States COR Clinical Research Oklahoma City Oklahoma
United States VA Palo Alto Health Care System Palo Alto California
United States Radiant Research Philadelphia Pennsylvania
United States Tatum Ridge Internal Medicine Phoenix Arizona
United States St. Joseph Mercy-Oakland Research Office Pontiac Michigan
United States New Hope Research of Oregon Portland Oregon
United States Sacramento Heart & Vascular Medical Associates Sacramento California
United States University of California-Davis; Department of Surgery Sacramento California
United States Saint Louis University Saint Louis Missouri
United States Pro Research Group, LLC San Antonio Texas
United States Clinical Research Center of California San Diego California
United States Cardiovascular Center of Sarasota Sarasota Florida
United States Scottsdale Cardiovascular Research Institute, LLC Scottsdale Arizona
United States Carolina Pharmaceutical Research Statesville North Carolina
United States North County Internal Medicine Vista California
United States Clinical Research Center of Georgia Warner Robins Georgia
United States Care Foundation, Inc Wausau Wisconsin
United States Mainline Health Heart Center Wynnewood Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Kos Pharmaceuticals

Country where clinical trial is conducted

United States, 

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