The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC
2 other identifiers
interventional
870
1 country
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 16, 2003
CompletedFirst Posted
Study publicly available on registry
October 20, 2003
CompletedNovember 2, 2006
October 1, 2006
October 16, 2003
October 31, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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 \<800.
You may not qualify if:
- 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 and unable to undergo washout as judged by the Investigator or due to personal choice.
- Systolic blood pressure ≥160 mmHg \&/or diastolic blood pressure ≥95 mmHg.
- Presence of clinically significant laboratory test abnormalities for liver or renal function tests, thyroid function or HgbA1C.
- History of alcohol abuse or currently drinks alcohol in excess.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Tatum Ridge Internal Medicine
Phoenix, Arizona, 85032, United States
Scottsdale Cardiovascular Research Institute, LLC
Scottsdale, Arizona, 85251, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
University of California-Davis; Department of Surgery
Sacramento, California, 95819, United States
Sacramento Heart & Vascular Medical Associates
Sacramento, California, 95825, United States
Clinical Research Center of California
San Diego, California, 92103, United States
North County Internal Medicine
Vista, California, 92083, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80200, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239, United States
Clinical Research Center of Georgia
Warner Robins, Georgia, 31093, United States
River Cities Cardiology, MPC
Jeffersonville, Indiana, 47130, United States
HPV Heart P.A.
Columbia, Maryland, 21044, United States
St. Joseph Mercy-Oakland Research Office
Pontiac, Michigan, 48341, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Carolina Pharmaceutical Research
Statesville, North Carolina, 28625, United States
COR Clinical Research
Oklahoma City, Oklahoma, 73104, United States
New Hope Research of Oregon
Portland, Oregon, 97219, United States
Penn State College of Medicine
Hershey, Pennsylvania, 17033, United States
Radiant Research
Philadelphia, Pennsylvania, 19115, United States
Mainline Health Heart Center
Wynnewood, Pennsylvania, 19096, United States
Clinical Cardiology Research Center
Dallas, Texas, 75246, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Pro Research Group, LLC
San Antonio, Texas, 78205, United States
Hampton Roads Center for Clinical Research, Inc.
Norfolk, Virginia, 23502, United States
Care Foundation, Inc
Wausau, Wisconsin, 54401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2003
First Posted
October 20, 2003
Study Start
October 1, 2003
Last Updated
November 2, 2006
Record last verified: 2006-10