Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication - Full Text View

Sponsor:	Kos Pharmaceuticals
Information provided by:	Kos Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00062556

Purpose

The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses, compared to diet control (this group will receive a tablet containing 50 mg. of immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused by a narrowing of their leg arteries, a condition called intermittent claudication.

At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study.

Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration) approved cholesterol modifying medications: Niaspan® (extended-release niacin) and lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication 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, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Niacin ER/Lovastatin on Peak Walking Time and Claudication Onset Time in Patients With Intermittent Claudication

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol 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:	366
Study Start Date:	January 2003
Estimated Study Completion Date:	March 2006

Detailed Description:

This is a Phase 3, 28-week, double-blind, diet-intervention, randomized, parallel group, three-arm, multi-center, dose-titration study.

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) and Claudication Onset Time (COT), calculated as the logarithm of the quotient of the time walked on treadmill at a visit divided by the time walked at baseline. Other efficacy measures will include Ankle Brachial Index (ABI), QoL measurements, composite of cardiovascular events (MI, stroke, vascular death, and lower limb amputations), and coronary and peripheral artery revascularization procedures. Safety variables will include serum transaminases, routine chemistry parameters, hematology, and AEs. 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 < 800mg/dL.

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
Systolic blood pressure ≥ 160 mmHg &/or diastolic blood pressure ≥ 95 mmHg
Presence of clinically significant laboratory test abnormalities for liver or renal function tests or HgbA1C.
History of alcohol abuse or currently drinks alcohol in excess.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	MA-02-010403, ICPOP
Study First Received:	June 9, 2003
Last Updated:	October 31, 2006
ClinicalTrials.gov Identifier:	NCT00062556 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 27, 2009