Clinical trial NCT00071266: The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC
Official title: The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - a Matrix Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intermittent Claudication
Peripheral Vascular Disease
Keywords: Intermittent Claudication
Peripheral Arterial Disease
Atherosclerosis
Niacin
Lovastatin
PAD
IC
Lead sponsor: Kos Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2003-10-20
Enrollment: 870
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

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