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

NCT00062556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2006-11-01

No results posted yet for this study

Summary

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.

Conditions

  • Intermittent Claudication
  • Peripheral Vascular Disease

Interventions

DRUG

Niacin Extended Release and Lovastatin Tablets

Sponsors & Collaborators

  • Kos Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Completion
2006-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00062556 on ClinicalTrials.gov