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

Peripheral Vascular Disease Clinical Trial

Official title:

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

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
• 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

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

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,