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

October 31, 2006 updated by: Kos Pharmaceuticals

Effect of Niacin ER/Lovastatin on Peak Walking Time and Claudication Onset Time in Patients With Intermittent Claudication

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

366

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kos Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

June 9, 2003

First Submitted That Met QC Criteria

June 11, 2003

First Posted (Estimate)

June 12, 2003

Study Record Updates

Last Update Posted (Estimate)

November 1, 2006

Last Update Submitted That Met QC Criteria

October 31, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-02-010403
  • ICPOP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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