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Completed Phase 3 Interventional

The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC

ClinicalTrials.gov ID: NCT00071266

Public ClinicalTrials.gov record NCT00071266. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 2:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - a Matrix Design

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00071266
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kos Pharmaceuticals
Industry
Enrollment
870 participants

Conditions and interventions

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2003 (Type not available)
Primary completion
Not listed
Completion
Not listed
Last update posted
Nov 2, 2006

Started 2003

United States locations

U.S. sites
26
U.S. states
17
U.S. cities
25
Facility City State ZIP Site status
Tatum Ridge Internal Medicine Phoenix Arizona 85032 —
Scottsdale Cardiovascular Research Institute, LLC Scottsdale Arizona 85251 —
VA Palo Alto Health Care System Palo Alto California 94304 —
University of California-Davis; Department of Surgery Sacramento California 95819 —
Sacramento Heart & Vascular Medical Associates Sacramento California 95825 —
Clinical Research Center of California San Diego California 92103 —
North County Internal Medicine Vista California 92083 —
University of Colorado Health Sciences Center Denver Colorado 80200 —
University of Connecticut Health Center Farmington Connecticut 06030 —
Cardiovascular Center of Sarasota Sarasota Florida 34239 —
Clinical Research Center of Georgia Warner Robins Georgia 31093 —
River Cities Cardiology, MPC Jeffersonville Indiana 47130 —
HPV Heart P.A. Columbia Maryland 21044 —
St. Joseph Mercy-Oakland Research Office Pontiac Michigan 48341 —
Saint Louis University St Louis Missouri 63104 —
Carolina Pharmaceutical Research Statesville North Carolina 28625 —
COR Clinical Research Oklahoma City Oklahoma 73104 —
New Hope Research of Oregon Portland Oregon 97219 —
Penn State College of Medicine Hershey Pennsylvania 17033 —
Radiant Research Philadelphia Pennsylvania 19115 —
Mainline Health Heart Center Wynnewood Pennsylvania 19096 —
Clinical Cardiology Research Center Dallas Texas 75246 —
Baylor College of Medicine Houston Texas 77030 —
Pro Research Group, LLC San Antonio Texas 78205 —
Hampton Roads Center for Clinical Research, Inc. Norfolk Virginia 23502 —
Care Foundation, Inc Wausau Wisconsin 54401 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00071266, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 2, 2006 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00071266 live on ClinicalTrials.gov.

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