The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC
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.
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
- 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
- Sep 30, 2003
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Nov 1, 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 1, 2006 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00071266 live on ClinicalTrials.gov.