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Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP) Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP) Clinical research trials and Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP) health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP). Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP) Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP) clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP) condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP)  Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP)
Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP)
For Condition: Peripheral Vascular Disease,Intermittent Claudication
Status: Recruiting
Sponsor(s): Kos Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional,Treatment,Randomized,Double-Blind,Dose Comparison,Parallel Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 40 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. Patient is able to comply with the protocol procedures & all follow-up visits. EXCLUSION CRITERIA: 1. Patient has an allergy, hypersensitivity, or intolerance to niacin, aspirin, statins, or their derivatives 2. 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 3. Patient is grossly obese (BMI 40) 4. Patient has documented CAD (angina pectoris, MI, coronary artery bypass graft surgery, angioplasty 5. Patient has systolic blood pressure 160 mmHg &/or diastolic blood pressure 95 mmHg at the Screening Visit; 6. At Screening, patient has an LDL-C level of 160mg/dL 7. 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
Total Enrollment: 375
Location and Contact Information:
Healthcore, Inc. *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Walter Powell
Radiant Research *Recruiting*
Philadelphia, Pennsylvania, 19115
United States
Recruiting Barry Packman
Diversified Clinical Research *Recruiting*
Murrieta, California, 92563
United States
Recruiting Irving Schwartz
Cleveland Cardiovascular Research Foundation *Recruiting*
Cleveland, Ohio, 44110
United States
Recruiting Dean Nukta
University of Tenn Health Science Center, Department of Pharmacology *Recruiting*
Memphis, Tennessee, 38163
United States
Recruiting Marshall Elam
Omega Medical Research *Recruiting*
Warwick, Rhode Island, 02886
United States
Recruiting David Fried
New Orleans Center for Clinical Research *Recruiting*
New Orleans, Louisiana, 70119
United States
Recruiting William Smith
Syracuse Preventive Cardiology *Recruiting*
Syracuse, New York, 13202
United States
Recruiting Stephen Nash
Arizona Heart Institute *Recruiting*
Phoenix, Arizona, 85006
United States
Recruiting Kris Vijay
Amulet, LLC *Recruiting*
New Orleans, Louisiana, 70124
United States
Recruiting Robert Larimer
UC Davis Medical Center, Division of Vascular Surgery *Recruiting*
Sacramento, California, 95817
United States
Recruiting David Dawson
Cardiology Consultants of Montgomery County *Recruiting*
Meadowbrook, Pennsylvania, 19046
United States
Recruiting Andrew Mustin
Miami Cardiology Group *Recruiting*
Miami, Florida, 33157
United States
Recruiting Paul Seigel
Baylor University Medical Center, Clinical Cardiology Research Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Cara East
Hampton Roads Center for Clinical Research, Inc. *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Barry Lubin
Apex Research Institute *Recruiting*
Santa Ana, California, 92705
United States
Recruiting Melvin Tonkon
University of Michigan Health Systems *Recruiting*
Ann Arbor, Michigan, 48109
United States
Recruiting Michael Grossman
Ochsner Clinic Foundation *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Samuel Money
U Mass Health Center, Division of Vascular Surgery *Recruiting*
Worcester, Massachusetts, 01609
United States
Recruiting Bruce Cutler
Radiant Research, Inc. *Recruiting*
Edina, Minnesota, 55435
United States
Recruiting James Zavoral
University of Colorado Health Science Center *Recruiting*
Denver, Colorado, 80262
United States
Recruiting Judy Regensteiner
National Clinical Research, Inc *Recruiting*
Richmond, Virginia, 23294
United States
Recruiting James McKenney
Tampa Bay Medical Research *Recruiting*
Clearwater, Florida, 33761
United States
Recruiting James Hampsey
Iowa Heart Center *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Laurie Kuestner
Baptist Clinical Research *Recruiting*
Pensacola, Florida, 32501
United States
Recruiting Fernando Kafie
The Care Group, LLC *Recruiting*
Indianapolis, Indiana, 46260
United States
Recruiting Elaine Moen
University of Minnesota Medical School *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Allan Hirsch
HPV Heart, PA *Recruiting*
Columbia, Maryland, 21044
United States
Recruiting William Herzog
University of Michigan Health Systems *Recruiting*
Ann Arbor, Michigan, 48109-0273
United States
Recruiting Sanjay Rajagopalan
Radiant Research Atlanta West *Recruiting*
Austell, Georgia, 30106
United States
Recruiting Stuart Simon
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Ryan Neal
Tru Med Ed *Recruiting*
Melbourne, Florida, 32901
United States
Recruiting Rajiv Chandra
Miami Research Associates *Recruiting*
Coral Gables, Florida, 33146
United States
Recruiting Theodore Feldman
Peripheral Vascular Associates *Recruiting*
San Antonio, Texas, 78215
United States
Recruiting Jeffrey Martinez
VA GulfCoast Veterans Healthcare Systems, Surgical Services *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting A. Kline
Tenet Care Research Center *Recruiting*
Kenner, Louisiana, 70065
United States
Recruiting W. Mann
Additional Information:
Study ID Numbers: MA-02-010403; ICPOP
Study Start Date: January 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062556
Other Peripheral Vascular Disease Studies:
1. Magnetic Resonance Imaging to Detect Blood Vessel Inflammation in Patients Undergoing Peripheral Balloon Angioplasty
2. Trial of VLTS-589 in Subjects with Intermittent Claudication
3. The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication - TROPIC
4. A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia.
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 Rhode Island Clinical Trials
Other Warwick Clinical Trials
Effect of Niacin Extended Release and Lovastatin tablets on Walking in Patients with Intermittent Claudication (ICPOP)
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