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The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC Clinical research trials and The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC. The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC clinical trial. Human subjects often get the best healthcare available for their The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC  The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC
The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC
For Condition: Peripheral Vascular Disease,Intermittent Claudication
Status: Recruiting
Sponsor(s): Kos Pharmaceuticals ,
Synopsis: 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.
Details: 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:
Study Type: Interventional,Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 40 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 1320
Location and Contact Information:
Oklahoma University Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Jorge Saucedo
Howard Ellison, MD *Recruiting*
Conyers, Georgia, 30094
United States
Recruiting Howard Ellison
Cardiovascular Center of Sarasota *Recruiting*
Sarasota, Florida, 34239
United States
Recruiting Mahfouz Shahawy
University of Rochester *Recruiting*
Rochester, New York, 14642
United States
Recruiting Thomas Pearson
Heart and Vascular Research Center *Recruiting*
Sarasota, Florida, 34239
United States
Recruiting Randy Hartman
Hospital for Joint Diseases *Recruiting*
New York City, New York, 10003
United States
Recruiting Peter Sheehan
Louisiana State University Cardiology *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Suresh Jain
Beacon Medical Research *Recruiting*
Indianapolis, Indiana, 46208
United States
Recruiting Paula Hall
University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7200
United States
Recruiting Sharada Chandra
Mainline Health Heart Center *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting David Naide
Diagnostic and Medical Clinic *Recruiting*
Mobile, Alabama, 36604
United States
Recruiting F. Lester
Penn State College of Medicine *Recruiting*
Hershey, Pennsylvania, 17033
United States
Recruiting David Han
Tyler Cardiovascular Consultants *Recruiting*
Tyler, Texas, 75701
United States
Recruiting Thaddeus Tolleson
John Dingell VA Medical Center *Recruiting*
Detroit, Michigan, 48301
United States
Recruiting Angela Vouyouka
The Lindner Center *Recruiting*
Cincinnati, Ohio, 45219
United States
Recruiting Dean Kereiakes
Viking Clinical Research *Recruiting*
Temecula, California, 92591
United States
Recruiting Jay Ferns
Jacksonville Center for Clinical Research *Recruiting*
Jacksonville, Florida, 32216
United States
Recruiting Michael Koren
University of Connecticut Health Center *Recruiting*
Farmington, Connecticut, 06030
United States
Recruiting Michael Dahn
Future Care Studies *Recruiting*
Springfield, Massachusetts, 01107
United States
Recruiting Adnan Dahdul
Abington Family Medicine *Recruiting*
Jenkintown, Pennsylvania, 19046
United States
Recruiting Neil Skolnik
Tatum Ridge Internal Medicine *Recruiting*
Phoenix, Arizona, 85032
United States
Recruiting Lawrence Gassner
VA Pitsburgh Healthcare System *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Edith Tzeng
Advanced Clinical Research *Recruiting*
Anaheim, California, 92801
United States
Recruiting Dennis Riff
Southern Illinois University *Recruiting*
Springfield, Illinois, 62702
United States
Recruiting Robert McLafferty
Radiant Research *Recruiting*
Chicago, Illinois, 60610
United States
Recruiting Jeffrey Geohas
Cardiology Consultants of Philadelphia *Recruiting*
Norristown, Pennsylvania, 19401
United States
Recruiting Arthur Belber
Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Robert Rosenson
COR Clinical Research, LLC *Recruiting*
Oklahoma City, Oklahoma, 73103
United States
Recruiting Clinton Corder
New Hope Research of Oregon *Recruiting*
Portland, Oregon, 97219
United States
Recruiting Patrick Rask
Spartanburg Pharmaceutical Research *Recruiting*
Spartanburg, South Carolina, 29307
United States
Recruiting Charles Fogarty
University of Texas Southwestern *Recruiting*
Dallas, Texas, 75390 9157
United States
Recruiting Patrick Clagett
Amarillo Heart Group *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting Ernesto Rivera
Merced Heart Institute *Recruiting*
Merced, California, 95340
United States
Recruiting Mani Nallasivan
North Dallas Research Associates *Recruiting*
McKinney, Texas, 75069
United States
Recruiting Muhammed Khan
Heart Care Associates *Recruiting*
Milwaukee, Wisconsin, 53233
United States
Recruiting Yoseph Shalev
Ritchard Fishman, MD *Recruiting*
Pico Rivera, California, 90660
United States
Recruiting Ritchard Fishman
UCSD Medical Center *Recruiting*
San Diego, California, 92103-8411
United States
Recruiting Ori Yehuda
Salus Clinical Research *Recruiting*
Murrieta, California, 92562
United States
Recruiting Frederick Wood
Carolina Pharmaceutical Research *Recruiting*
Statesville, North Carolina, 28625
United States
Recruiting Joseph Moran
Carolina Research Associates *Recruiting*
Columbia, South Carolina, 29204
United States
Recruiting James Herman
Discovery Alliance *Recruiting*
Pensacola, Florida, 32504
United States
Recruiting Stuart Harlin
Indiana University School of Medicine *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Michael Dalsing
VA Medical Center *Recruiting*
Minneapolis, Minnesota, 55417
United States
Recruiting Stephen Santilli
Mid Ohio Heart Clinic, Inc *Recruiting*
Mansfield, Ohio, 44906
United States
Recruiting William Miller
Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29403
United States
Recruiting James Thomas
VA Palo Alto Health Care System *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Ronald Dalman
St. Joseph Mercy Oakland Research Office *Recruiting*
Pontiac, Michigan, 48341
United States
Recruiting Kiritkumar Patel
Emory University School of Medicine *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Elliot Chaikof
Stanford University *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Stephen Fortmann
University of Pittsburgh Medical Center *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Michael Makaroun
Temple University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19140
United States
Recruiting John Blebea
Saint Louis University *Recruiting*
St. Louis, Missouri, 63104
United States
Recruiting Catherine Wittgen
Radiant Research *Recruiting*
Elk Grove Village, Illinois, 60007
United States
Recruiting Warren Pierce
Black Hills Cardiovascular Research Group *Recruiting*
Rapid City, South Dakota, 57701
United States
Recruiting Alex Schabauer
Thoracic and Cardiovascular Foundation *Recruiting*
Lansing, Michigan, 48910
United States
Recruiting David Strobl
Radiant Research *Recruiting*
Philadelphia, Pennsylvania, 19115
United States
Recruiting Antoinette Mangione
Fox Valley Cardiovascular Consultants *Recruiting*
Aurora, Illinois, 60506
United States
Recruiting Santosh Gill
North County Internal Medicine *Recruiting*
Vista, California, 92083
United States
Recruiting John LaFata
Inova Alexandria Hospital *Recruiting*
Alexandria, Virginia, 22304
United States
Recruiting Keith Sterling
Charlotte Heart Group Research *Recruiting*
Port Charlotte, Florida, 33952
United States
Recruiting Ricardo Martinez
West Virginia University *Recruiting*
Charleston, West Virginia, 25304
United States
Recruiting Robert Touchon
Think Tank Clinical Research *Recruiting*
Carlsbad, California, 92008
United States
Recruiting Maurice Buchbinder
Advocate Medical Group Cardiology *Recruiting*
Park Ridge, Illinois, 60068
United States
Recruiting Walter Myalls
VA Las Vegas *Recruiting*
Las Vegas, Nevada, 89102
United States
Recruiting Kenneth McIntyre
Long Beach VA Medical Center *Recruiting*
Long Beach, California, 90822
United States
Recruiting Ian Gordon
Discovery Alliance *Recruiting*
Mobile, Alabama, 36606
United States
Recruiting William Higgs
Care Foundation, Inc *Recruiting*
Wausau, Wisconsin, 54401
United States
Recruiting David Murdock
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting James Zidar
Clinical Research Center of California *Recruiting*
San Diego, California, 92103
United States
Recruiting Jeffrey Mullvain
River Cities Cardiology, MPC *Recruiting*
Jeffersonville, Indiana, 47130
United States
Recruiting D. Denny
Medical Research Institute *Recruiting*
Slidell, Louisiana, 70458
United States
Recruiting Vasanth Bethala
Tufts New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Richard Karas
Rhode Island Hospital *Recruiting*
Providence, Rhode Island, 02903
United States
Recruiting Timothy Murphy
Cardiovascular Associates of Miami *Recruiting*
Miami, Florida, 33140
United States
Recruiting Antonio Rosado
Manhattan Eye Ear and Throat Hospital *Recruiting*
New York City, New York, 10021
United States
Recruiting Michael Jaff
David Geffen School of Medicine *Recruiting*
Los Angeles, California, 90095-6908
United States
Recruiting Samuel Ahn
Additional Information:
Study ID Numbers: MA-03-010401; The TROPIC Study
Study Start Date: October 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071266
Other Peripheral Vascular Disease Studies:
1. Trial of VLTS-589 in Subjects with Intermittent Claudication
2. Extract of Ginkgo Biloba (EGB 761) and Vascular Function
3. The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC
4. Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD.
5. Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP)
Related Studies:
Other Peripheral Vascular Disease Clinical Trials
Other Ohio Clinical Trials
Other Mansfield Clinical Trials
The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC
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