You are being asked to participate in a research study that will determine if Niacin ER/Lovastatin at two different doses compared to diet control (this group will receive a tablet containing 50 mg. of immediate-release niacin) is a safe medicine that will reduce leg pain in subjects with intermittent claudication. Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration) approved cholesterol modifying medications: Niaspan® (extended-release niacin) and lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved by the FDA under the name of AdvicorTM for use in the treatment of elevated cholesterol. The use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational. An investigational use is one that is not approved by the FDA.

At least 375 subjects, with a similar medical condition to yours will participate in this study. This study will use competitive enrollment. This means that when a target number of subjects have entered the treatment phase of the study, all further enrollment will be closed. Therefore, it is possible that you could be in the screening phase, and be discontinued without your consent if the target number of subjects have already entered the study.

The purpose of this study is to evaluate the effect of Niacin ER/Lovastatin (at two different doses) compared with a diet-only control group in subjects with intermittent claudication (leg pain), a condition caused by narrowing of the leg arteries.

Duration of the Study

You will be monitored for up to six (6) weeks in order to determine if you qualify for the study. During the six-week qualification period, you will return to the study center for 3-4 study visits. Qualification for the study includes:

• having experienced “intermittent claudication” (leg pain) for at least 6 months
• 3-4 treadmill tests (walking tests)
• determination of your legs’ blood pressure.

If you qualify and choose to participate, your participation in this study will last approximately nineteen months.

Condition	Treatment or Intervention
Intermittent Claudication Peripheral Vascular Disease	Drug: Niacin Extended Release and Lovastatin Tablets

Further Study Details: 

Expected Total Enrollment:  375

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 or 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 screening, patient has a PWT of 1 to 20 minutes inclusive. For patients who do not require drug washout as listed in the Drug list 1 in Section 8.0, the PWT must be 1 to 15 minutes inclusive.
• 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 minutes inclusive calculated using the values of two consecutive visits.
• Patient has a doppler-measured pre-treadmill ABI of 0.90 or lower after 10 minutes of rest at Screening. OR If pre-treadmill ABI is > 0.90, a 20% reduction from the pre-treadmill ABI value, when measured within one minute 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. TBI will be evaluated for screening purposes only.
• 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.
• Patient is able to comply with the protocol procedures & all follow-up visits.

EXCLUSION CRITERIA:

• Patient has an allergy, hypersensitivity, or intolerance to niacin, aspirin, statins, or their derivatives
• Patient has severe neuropathy diagnosed by loss of vibratory sensation (i.e., complete lack of vibratory sensation) in either foot using a 128 MHz tuning fork
• Patient is grossly obese (BMI ≥ 40)
• Patient has documented CAD (angina pectoris, MI, coronary artery bypass graft surgery, angioplasty
• Patient has systolic blood pressure ≥ 160 mmHg &/or diastolic blood pressure ≥ 95 mmHg at the Screening Visit;
• At Screening, patient has an LDL-C level of ≥ 160mg/dL
• Patient has any of the following abnormalities: *ALT &/or AST > 1 .3xULN *creatinine clearance < 30mL/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

Roger Kohler, MS      (800) 722-4567 

Alabama
      Diagnostic and Medical Clinic, Mobile,  Alabama,  36604,  United States; Recruiting
Arizona
      Arizona Heart Institute, Phoenix,  Arizona,  85006,  United States; Recruiting
California
      UC Davis Medical Center, Division of Vascular Surgery, Sacramento,  California,  95817,  United States; Recruiting
      Apex Research Institute, Santa Ana,  California,  92705,  United States; Recruiting
      North County Internal Medicine, Vista,  California,  92083,  United States; Recruiting
      Clinical Research Center of California, San Diego,  California,  92103,  United States; Recruiting
Colorado
      University of Colorado Health Science Center, Denver,  Colorado,  80262,  United States; Recruiting
      Denver Health and Hospital Authority, Denver,  Colorado,  80204,  United States; Recruiting
Delaware
      Healthcore, Inc., Newark,  Delaware,  19713,  United States; Recruiting
Florida
      Miami Research Associates, Coral Gables,  Florida,  33146,  United States; Recruiting
      Tampa Bay Medical Research, Clearwater,  Florida,  33761,  United States; Recruiting
      Baptist Clinical Research, Pensacola,  Florida,  32501,  United States; Recruiting
      Tru Med Ed, Melbourne,  Florida,  32901,  United States; Recruiting
      Miami Cardiology Group, Miami,  Florida,  33157,  United States; Recruiting
      Cardiovascular Center of Sarasota, Sarasota,  Florida,  34239,  United States; Recruiting
      Charlotte Heart Group Research, Port Charlotte,  Florida,  33952,  United States; Recruiting
Georgia
      Radiant Research Atlanta West, Austell,  Georgia,  30106,  United States; Recruiting
      Howard Ellison, MD, Conyers,  Georgia,  30094,  United States; Recruiting
Indiana
      The Care Group, LLC, Indianapolis,  Indiana,  46260,  United States; Recruiting
Iowa
      Iowa Heart Center, Des Moines,  Iowa,  50314,  United States; Recruiting
Louisiana
      Amulet, LLC, New Orleans,  Louisiana,  70124,  United States; Recruiting
      Tenet Care Research Center, Kenner,  Louisiana,  70065,  United States; Recruiting
      Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States; Recruiting
      New Orleans Center for Clinical Research, New Orleans,  Louisiana,  70119,  United States; Recruiting
      Advanced Medical Reasearch, Hammond,  Louisiana,  70403,  United States; Recruiting
Maryland
      HPV Heart, PA, Columbia,  Maryland,  21044,  United States; Recruiting
Massachusetts
      U Mass Health Center, Division of Vascular Surgery, Worcester,  Massachusetts,  01609,  United States; Recruiting
Michigan
      University of Michigan Health Systems, Ann Arbor,  Michigan,  48109-0273,  United States; Recruiting
      University of Michigan Health Systems, Ann Arbor,  Michigan,  48109,  United States; Recruiting
      St. Joseph Mercy Oakland Research Office, Pontiac,  Michigan,  48341,  United States; Recruiting
Minnesota
      Radiant Research, Inc., Edina,  Minnesota,  55435,  United States; Recruiting
      University of Minnesota Medical School, Minneapolis,  Minnesota,  55455,  United States; Recruiting
      VA Medical Center, Minneapolis,  Minnesota,  55417,  United States; Recruiting
Mississippi
      VA GulfCoast Veterans Healthcare Systems, Surgical Services, Biloxi,  Mississippi,  39531-2410,  United States; Recruiting
Missouri
      Saint Louis University, St. Louis,  Missouri,  63104,  United States; Recruiting
      Saint Lukes Lipid & Diabetic Research Center, Kansas City,  Missouri,  64111,  United States; Recruiting
New York
      Syracuse Preventive Cardiology, Syracuse,  New York,  13202,  United States; Recruiting
      Strong Memorial Hospital, Strong Heart Program, Rochester,  New York,  14618,  United States; Recruiting
      Hospital for Joint Diseases, Diabetes Foot and Ankle Center, New York,  New York,  10003,  United States; Recruiting
North Carolina
      Carolina Pharmaceutical Research, Statesville,  North Carolina,  28625,  United States; Recruiting
Ohio
      Cleveland Cardiovascular Research Foundation, Cleveland,  Ohio,  44110,  United States; Recruiting
      The Lindner Center, Cincinnati,  Ohio,  45219,  United States; Recruiting
      Forum Health/ Western Reserve Health Care System, Youngstown,  Ohio,  44501,  United States; Recruiting
Oklahoma
      COR Clinical Research, LLC, Oklahoma City,  Oklahoma,  73103,  United States; Recruiting
Oregon
      Advance Clinical Trials, Inc, Eugene,  Oregon,  97401,  United States; Recruiting
      New Hope Reaserch of Oregon, Portland,  Oregon,  97209,  United States; Recruiting
Pennsylvania
      Radiant Research, Philadelphia,  Pennsylvania,  19115,  United States; Recruiting
      Cardiology Consultants of Montgomery County, Meadowbrook,  Pennsylvania,  19046,  United States; Recruiting
      Penn State College of Medicine, Hershey,  Pennsylvania,  17033,  United States; Recruiting
Rhode Island
      Omega Medical Research, Warwick,  Rhode Island,  02886,  United States; Recruiting
Tennessee
      University of Tenn Health Science Center, Department of Pharmacology, Memphis,  Tennessee,  38163,  United States; Recruiting
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
      Baylor University Medical Center, Clinical Cardiology Research Center, Dallas,  Texas,  75246,  United States; Recruiting
      North Dallas Research Associates, McKinney,  Texas,  75069,  United States; Recruiting
Virginia
      National Clinical Research, Inc, Richmond,  Virginia,  23294,  United States; Recruiting
      Hampton Roads Center for Clinical Research, Inc., Norfolk,  Virginia,  23502,  United States; Recruiting

Study ID Numbers:  MA-02-010403; ICPOP
Record last reviewed:  January 2005
Last Updated:  January 13, 2005
Record first received:  June 9, 2003
ClinicalTrials.gov Identifier:  NCT00062556
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08