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Clinical Trial: The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC
This study is currently recruiting patients.
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Purpose
The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan and Lovastatin with each other and to a diet-only control group, in subjects with leg pain caused by a narrowing of their leg arteries.
At least 1320 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 (AdvicorTM), 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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Intermittent Claudication Peripheral Vascular Disease | Drug: Niacin Extended Release and Lovastatin Tablets | Phase III |
MedlinePlus related topics: Leg Injuries and Disorders; Peripheral Vascular Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication– a Matrix Design
Further Study Details:
Expected Total Enrollment: 1320
Study start: October 2003
This is a Phase 3, 80-week, 2-part (Parts A and B), double-blind, diet-intervention, randomized, parallel group, eleven-arm, multi-center, dose-escalation study evaluating the safety and efficacy of NL in patients with intermittent claudication (IC).
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) calculated from the logarithm of the quotient of the time walked on treadmill at the Week 32 Visit divided by the time walked at baseline. Other efficacy measures will include PWT percent change at Week 80, Claudication Onset Time (COT) percent changes from baseline at Weeks 32 and 80, Ankle Brachial Index (ABI), Quality of Life (QoL) percent changes at Weeks 32 and 80, lower limb amputations, composite of cardiovascular events (MI, stroke, and vascular death), and coronary and peripheral artery revascularizations. Safety variables will include serum transaminases, routine chemistry parameters, hematology, and adverse events. Pharmacokinetic analyses will be conducted as well.
Eligibility
Ages Eligible for Study: 40 Years and above, Genders Eligible for Study: Both
Criteria
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 nor to breast-feed. Women of childbearing potential must commit to using oral contraception, IUD, or a double-barrier method of contraception. Women using oral contraception must have done so for 3 months prior to randomization & continue to do so for the duration of the study. To be considered not of childbearing potential, women must be post-menopausal for at least 2 years or surgically sterile.
- Patient with a 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.
- At qualification, patient has a reproducible PWT variability of ≤20% between Qualification Visits 1 & 2 over a 4 to 10 day period if variability is >20%, a third treadmill test will be performed within an additional 4 to 10 days. In this case, there must be a variability of ≤20% between Qualification Visits 2 & 3 for patient qualification. & patient has a mean PWT of 1 to 15 min inclusive, calculated using the values of two consecutive visits.
- Patient has a doppler-measured pre-treadmill ABI of 0.90 or lower after 10 min of rest at screening. Or if pre-treadmill ABI is > 0.90, a 20% reduction from the pre-treadmill ABI value, when measured within 1 min after claudication-limiting treadmill testing, must be obtained. This will be evaluated at screening only. Or for patients with an ABI of > 1.3 (non-compressible arteries), a first toe pressure measurement will be allowed. In this case, a Toe-Brachial Index (TBI) of < 0.7 must be obtained for patient qualification.
- Patient’s baseline LDL-C level must be a mean value of <160 mg/dL measured in Qualification Visits 1 & 2; if mean value is ≥160 mg/dL, a third value will be obtained within 4-10 days. In this case, the mean LDL-C of the last two tests must be <160 mg/dL for patient qualification.
EXCLUSION CRITERIA:
- Patient has severe neuropathy diagnosed by loss of vibratory sensation in either foot using a 128 MHz tuning fork.
- Patient has critical limb ischemia defined as ischemic rest pain, gangrene, ulceration, or pending amputation of a lower extremity due to severe PAD.
- Patient has had surgical intervention to alleviate symptoms of claudication within 6 months of randomization or endovascular interventions within 3 months of randomization.
- Patient has documented CAD.
- At Screening patient has systolic blood pressure ≥160 mmHg &/or diastolic blood pressure ≥95 mmHg.
- At Screening, patient has an LDL-C level of ≥160 mg/dL
- Patient has any of the following abnormalities: * ALT &/or AST >l.3xULN * creatinine clearance < 30 mL/min * CPK elevation >3xULN * HgbA1c >8.5% * active gout symptoms &/or uric acid level >1 .3xULN * triglycerides ≥800mg/dL * active peptic ulcer * active hepatitis * life expectancy <2 years
- Patient drinks >14 alcoholic drinks per week or has a previous history of substance abuse or dependency.
- Patient has a history of any of the following: * pancreatitis * unstable angina, MI, coronary artery bypass graft surgery, angioplasty, deep vein thrombosis, transient ischemic attack, or stroke within 3 months of randomization * Buerger’s disease * liver disease * diabetic coma or ketoacidosis * fibromyalgia, myopathy, rhabdomyolysis, unexplained muscle pain or weakness * discontinuation of a statin due to myalgia, myopathy, rhabdomyolysis, muscle weakness or muscular disorder * unexplained CPK elevation ≥ 10x ULN
Location and Contact Information
Roger Kohler, MS (800) 722-4567
Alabama
Discovery Alliance, Mobile, Alabama, 36606, United States; Recruiting
William Higgs, MD, Principal Investigator
Arizona
Tatum Ridge Internal Medicine, Phoenix, Arizona, 85032, United States; Recruiting
Lawrence Gassner, MD, Principal Investigator
California
David Geffen School of Medicine, Los Angeles, California, 90095-6908, United States; Recruiting
Samuel Ahn, MD, Principal Investigator
UCSD Medical Center, San Diego, California, 92103-8411, United States; Recruiting
Ori B Yehuda, MD, Principal Investigator
Think Tank Clinical Research, Carlsbad, California, 92008, United States; Recruiting
Maurice Buchbinder, MD, Principal Investigator
VA Palo Alto Health Care System, Palo Alto, California, 94304, United States; Recruiting
Ronald Dalman, MD, Principal Investigator
Viking Clinical Research, Temecula, California, 92591, United States; Recruiting
Jay Ferns, DO, Principal Investigator
Ritchard Fishman, MD, Pico Rivera, California, 90660, United States; Recruiting
Ritchard Fishman, MD, Principal Investigator
Stanford University, Palo Alto, California, 94304, United States; Recruiting
Stephen Fortmann, MD, Principal Investigator
Long Beach VA Medical Center, Long Beach, California, 90822, United States; Recruiting
Ian Gordon, MD, Principal Investigator
Merced Heart Institute, Merced, California, 95340, United States; Recruiting
Mani Nallasivan, MD, Principal Investigator
Advanced Clinical Research, Anaheim, California, 92801, United States; Recruiting
Dennis Riff, MD, Principal Investigator
Salus Clinical Research, Murrieta, California, 92562, United States; Recruiting
Frederick Wood, MD, Principal Investigator
Connecticut
University of Connecticut Health Center, Farmington, Connecticut, 06030, United States; Recruiting
Michael Dahn, MD, Principal Investigator
Florida
Discovery Alliance, Pensacola, Florida, 32504, United States; Recruiting
Stuart Harlin, MD, Principal Investigator
Heart and Vascular Research Center, Sarasota, Florida, 34239, United States; Recruiting
Randy Hartman, MD, Principal Investigator
Jacksonville Center for Clinical Research, Jacksonville, Florida, 32216, United States; Recruiting
Michael Koren, MD, Principal Investigator
Cardiovascular Associates of Miami, Miami Beach, Florida, 33140, United States; Recruiting
Antonio Rosado, MD, Principal Investigator
Georgia
Emory University School of Medicine, Atlanta, Georgia, 30322, United States; Recruiting
Elliot Chaikof, MD, Principal Investigator
Illinois
Radiant Research, Chicago, Illinois, 60610, United States; Recruiting
Jeffrey Geohas, MD, Principal Investigator
Fox Valley Cardiovascular Consultants, Aurora, Illinois, 60506, United States; Recruiting
Santosh Gill, MD, Principal Investigator
Southern Illinois University, Springfield, Illinois, 62702, United States; Recruiting
Robert McLafferty, MD, Principal Investigator
Advocate Medical Group Cardiology, Park Ridge, Illinois, 60068, United States; Recruiting
Walter Myalls, MD, Principal Investigator
Radiant Research, Elk Grove Village, Illinois, 60007, United States; Recruiting
Warren Pierce, MD, Principal Investigator
Northwestern University, Chicago, Illinois, 60611, United States; Recruiting
Robert Rosenson, MD, Principal Investigator
Indiana
Indiana University School of Medicine, Indianapolis, Indiana, 46202, United States; Recruiting
Michael Dalsing, MD, Principal Investigator
River Cities Cardiology, MPC, Jeffersonville, Indiana, 47130, United States; Recruiting
D. Marty Denny, MD, Principal Investigator
Beacon Medical Research, Indianapolis, Indiana, 46208, United States; Recruiting
Paula Hall, MD, Principal Investigator
Kansas
University of Kansas Medical Center, Kansas City, Kansas, 66160-7200, United States; Recruiting
Sharada Chandra, MD, Principal Investigator
Louisiana
Medical Research Institute, Slidell, Louisiana, 70458, United States; Recruiting
Vasanth Bethala, MD, Principal Investigator
Louisiana State University Cardiology, New Orleans, Louisiana, 70112, United States; Recruiting
Suresh Jain, MD, Principal Investigator
Massachusetts
Future Care Studies, Springfield, Massachusetts, 01107, United States; Recruiting
Adnan Dahdul, MD, Principal Investigator
Tufts New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
Richard Karas, MD, Principal Investigator
Michigan
Thoracic and Cardiovascular Foundation, Lansing, Michigan, 48910, United States; Recruiting
David Strobl, DO, Principal Investigator
John Dingell VA Medical Center, Detroit, Michigan, 48301, United States; Recruiting
Angela Vouyouka, MD, Principal Investigator
Minnesota
VA Medical Center, Minneapolis, Minnesota, 55417, United States; Recruiting
Stephen Santilli, MD, Principal Investigator
Missouri
Saint Louis University, Saint Louis, Missouri, 63104, United States; Recruiting
Catherine Wittgen, MD, Principal Investigator
Nevada
VA Las Vegas, Las Vegas, Nevada, 89102, United States; Recruiting
Kenneth McIntyre, MD, Principal Investigator
New York
Manhattan Eye Ear and Throat Hospital, New York, New York, 10021, United States; Recruiting
Michael Jaff, DO, Principal Investigator
University of Rochester, Rochester, New York, 14642, United States; Recruiting
Thomas Pearson, MD, Principal Investigator
Hospital for Joint Diseases, New York, New York, 10003, United States; Recruiting
Peter Sheehan, MD, Principal Investigator
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States; Recruiting
James Zidar, MD, Principal Investigator
Ohio
Mid Ohio Heart Clinic, Inc, Mansfield, Ohio, 44906, United States; Recruiting
William Miller, MD, Principal Investigator
Oklahoma
Oklahoma University Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Jorge Saucedo, MD, Principal Investigator
Oregon
New Hope Research of Oregon, Portland, Oregon, 97219, United States; Recruiting
Patrick Rask, MD, Principal Investigator
Pennsylvania
Cardiology Consultants of Philadelphia, Norristown, Pennsylvania, 19401, United States; Recruiting
Arthur Belber, MD, Principal Investigator
Temple University Hospital, Philadelphia, Pennsylvania, 19140, United States; Recruiting
John Blebea, MD, Principal Investigator
Penn State College of Medicine, Hershey, Pennsylvania, 17033, United States; Recruiting
David Han, MD, Principal Investigator
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15232, United States; Recruiting
Michael Makaroun, MD, Principal Investigator
Radiant Research, Philadelphia, Pennsylvania, 19115, United States; Recruiting
Antoinette Mangione, MD, Principal Investigator
Mainline Health Heart Center, Wynnewood, Pennsylvania, 19096, United States; Recruiting
David Naide, MD, Principal Investigator
Abington Family Medicine, Jenkintown, Pennsylvania, 19046, United States; Recruiting
Neil Skolnik, MD, Principal Investigator
VA Pitsburgh Healthcare System, Pittsburgh, Pennsylvania, 15213, United States; Recruiting
Edith Tzeng, MD, Principal Investigator
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting
Timothy Murphy, MD, Principal Investigator
South Carolina
Spartanburg Pharmaceutical Research, Spartanburg, South Carolina, 29307, United States; Recruiting
Charles Fogarty, MD, Principal Investigator
Carolina Research Associates, Columbia, South Carolina, 29204, United States; Recruiting
James Herman, MD, Principal Investigator
Medical University of South Carolina, Charleston, South Carolina, 29403, United States; Recruiting
James Thomas, MD, Principal Investigator
South Dakota
Black Hills Cardiovascular Research Group, Rapid City, South Dakota, 57701, United States; Recruiting
Alex Schabauer, MD, Principal Investigator
Texas
University of Texas Southwestern, Dallas, Texas, 75390 9157, United States; Recruiting
Patrick Clagett, MD, Principal Investigator
North Dallas Research Associates, McKinney, Texas, 75069, United States; Recruiting
Muhammed A Khan, MD, Principal Investigator
Amarillo Heart Group, Amarillo, Texas, 79106, United States; Recruiting
Ernesto Rivera, MD, Principal Investigator
Tyler Cardiovascular Consultants, Tyler, Texas, 75701, United States; Recruiting
Thaddeus Tolleson, MD, Principal Investigator
Virginia
Inova Alexandria Hospital, Alexandria, Virginia, 22304, United States; Recruiting
Keith Sterling, MD, Principal Investigator
West Virginia
West Virginia University, Charleston, West Virginia, 25304, United States; Recruiting
Robert Touchon, MD, Principal Investigator
Wisconsin
Care Foundation, Inc, Wausau, Wisconsin, 54401, United States; Recruiting
David Murdock, MD, Principal Investigator
Heart Care Associates, Milwaukee, Wisconsin, 53233, United States; Recruiting
Yoseph Shalev, MD, Principal Investigator
More Information
Study ID Numbers: MA-03-010401; The TROPIC Study
Record last reviewed: July 2004
Last Updated: October 28, 2004
Record first received: October 16, 2003
ClinicalTrials.gov Identifier: NCT00071266
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: July 2004
Last Updated: October 28, 2004
Record first received: October 16, 2003
ClinicalTrials.gov Identifier: NCT00071266
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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