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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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: Peripheral Arterial Disease

Drug Information available for: Niacin Niacinamide Lovastatin

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hiatt WR, Hirsch AT, Creager MA, Rajagopalan S, Mohler ER, Ballantyne CM, Regensteiner JG, Treat-Jacobson D, Dale RA, Rooke T. Effect of niacin ER/lovastatin on claudication symptoms in patients with peripheral artery disease. Vasc Med. 2010 Jun;15(3):171-9. doi: 10.1177/1358863X09360579. Epub 2010 Mar 8.


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


Vascular Diseases Intermittent Claudication Peripheral Vascular Diseases Peripheral Arterial Disease Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Signs and Symptoms Atherosclerosis Niacin Lovastatin L 647318 Dihydromevinolin Niacinamide	Nicotinic Acids Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016