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Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS) Clinical research trials and Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS) health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS). Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS) Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS) clinical trial. Test subjects typically receive the most expert healthcare available for their Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS) condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS)  Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS)
Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS)
For Condition: Atherosclerosis,Dyslipidemia,Stroke,Coronary Heart Disease,Hypercholesterolemia
Status: Recruiting
Sponsor(s): Kos Pharmaceuticals ,
Synopsis: The purpose of this study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia). At least 1000 subjects with a similar medical condition to yours will take part in this study, at sites within the United States. Niacin and simvastatin are medications that have been individually approved to treat high cholesterol. Kos has developed an investigational formula combining both niacin and simvastatin, named in this study as NS, for the treatment of cholesterol and lipid disorders (high fat content in your blood). Different doses of NS (the study drug) will be evaluated, with tablets being made from different dosages of combined niacin extended release (ER) and simvastatin immediate release (IR). The use of NS to treat lipid disorders is considered investigational. An investigational use is one that is not approved by the U.S. Food and Drug Administration (FDA). Please note: If you agree to participate in the study, you must stop taking your cholesterol lowering medications except Zocor®. In addition, prohibited medications that could interfere with the study drug will need to be discontinued for a minimum of 6 weeks before Qualification Visits and for the length of the study. Please discuss this with your study doctor.
Details: Objectives: To evaluate the safety and efficacy of the combination product niacin ER and simvastatin (NS) as a second line therapy in patients with dyslipidemia and to compare flushing rates between two Titration Schedules for NS. Population: Enrollment: Men and women, 21 years of age or older, with Type II hyperlipidemia (i.e., patient does not have hyperlipidemia caused by an uncontrolled, underlying disease state such as hypothyroidism). Three distinct patient groups will be screened for this study. They include: A. No Medication Group This group consists of patients who are not taking any lipid modifying medication at Screening who meet all Screening Entry Criteria but who do not satisfy the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Low-Density Lipoprotein Cholesterol (LDL-C) goals. To be eligible for participation, patients either have been compliant with the Therapeutic Lifestyle Changes (TLC) diet for ≥ 6 weeks or will demonstrate compliance during participation in the Run-In Phase. During the Run-In Phase, patients will receive Zocor 40 mg daily. At the end of the Run-In Phase, patients will be evaluated for Lipid Qualification. B. Zocor 40 mg Group This group consists of patients who have taken Zocor 40 mg daily for ≥ 6 weeks, however, do not satisfy LDL and/or non-HDL-C NCEP ATP III treatment goals at Screening (see Table 2, Section 4.1). If a patient has taken this medication regimen for ≥ 6 weeks, has been TLC diet compliant for at least 6 weeks prior to Screening, and has satisfied all other screening criteria, the Run-In Phase will be skipped and the patient will proceed directly to the Lipid Qualification Phase. C. Other Medication Group This group consists of patients who are taking any lipid modifying medications other than Zocor 40 mg, including those patients taking Zocor doses less than 40 mg per day. Prior to entering the Run-In Phase, Screening Entry Criteria must be met, NCEP ATP III treatment goals for LDL-C and/or non-HDL-C must not be satisfied, and patients must discontinue all lipid modifying medication. During the Run-In Phase, patients will receive Zocor 40 mg daily and maintain TLC dietary compliance for 6 weeks. At the end of the Run-In Phase, patients will be evaluated for Lipid Qualification. At Screening, patients who are taking Zocor doses greater than 40 mg daily will be ineligible for participation in the study. Screening Entry Criteria include: 1) Mean triglycerides < 500 mg/dL; 2) Patients must fulfill criteria of one of the following groups: No Medication, Zocor 40 mg, or Other Medication; 3) For patients in both the Zocor 40 mg and Other Medication Groups: LDL C and/or non HDL C exceeds NCEP ATP III treatment goal; 4) For patients in the No Medication Group: LDL C exceeds NCEP ATP III level for which initiating drugtherapy is merited; The following safety laboratory testing will occur at Qualification Visit 2: 1) ALT and AST ≤ 1.3 times upper limit of normal (ULN); 2) CPK ≤ 3 times ULN. Design: This is a multi-center, Phase III, open-label, parallel group study, consisting of randomization into one of two Titration Schedules at the start of the Treatment Phase. After completing the assigned Titration Schedule A or B, all patients will receive NS 2000/40 for up to an additional 36 or 40 weeks, respectively. Early Termination may shorten the length of time in the open-label Treatment Phase. Screening Phase: The Screening visit is required for study enrollment. Lipid and laboratory safety evaluations will be conducted as well as assessment for TLC dietary compliance. Run-In Phase: This phase is not required for patients who have been taking Zocor 40mg daily and are TLC diet compliant for ≥ 6 weeks prior to Screening. All patients participating in this phase will receive Zocor 40 mg daily (after discontinuing other lipid modifying medication, if necessary) while following the TLC diet. Lipid Qualification Phase: This phase is necessary to qualify for Randomization. Following the 6-week Run-In Phase, (or Screening for patients exempt from Run-In Phase) lipid panel evaluation will be done. Qualification Visits 1 and 2 (and Qualification 3, if necessary) will be obtained 7 ± 3 days apart. Patients meeting the following Lipid Qualification Criteria will be randomized to the Treatment Phase: 1. LDL-C demonstrates ≤ 15% variability. The LDL-C values of two consecutive blood samples drawn at Qualification 1 and Qualification 2 (Qualification 3, if necessary), taken 7 ± 3 days apart, must be within 15% of each other. 2. Based on the average LDL C and non-HDL C values at Qualification Visits 1 and 2 (or 2 and 3, if required), LDL C and/or non-HDL C does not meet NCEP ATP III treatment goals. Randomization: Randomization occurs after patients have met Lipid Qualification and may be considered the initiation of the Treatment Phase. Patients will be randomized in a 1:1 fashion to either: Titration Schedule A: 4 weeks on each escalating dose of NS 500/40, NS 1000/40, and NS 1500/40, followed by NS 2000/40 for 36 weeks. Titration Schedule B: 4 weeks on each escalating dose of NS 500/40 and NS 1000/40, followed by NS 2000/40 for 40 weeks. Treatment Phase: This phase is defined as the time period from Randomization to Week 48 or Early Termination. Study medication will be taken once daily with a low-fat snack at bedtime. Patients will be advised that one 325 mg non-enteric coated aspirin may be taken ½ hour prior to study medication to help prevent possible flushing effects commonly associated with niacin products. Patients already taking 325 mg non-enteric coated aspirin for prophylaxis (e.g., for heart disease) will be advised to take the aspirin ½ hour prior to taking study medication. The Site will notify the Sponsor regarding patients who are taking other aspirin formulations. By Week 20, if the patient does not satisfy LDL C treatment goal, based on risk criteria, the patient will be withdrawn from the study.
Eligibility:
Study Type: Interventional,Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: In order to participate, all of the following criteria must be answered “Yes”: - Patients 21 years of age or older. Women are not pregnant or breast-feeding & are not planning to become pregnant or to breast-feed during participation in this study. Women of childbearing potential must commit to using oral contraception, IUD, or a double-barrier method of contraception. - Patient has agreed to & signed written Informed Consent & HIPAA forms. - Patient has primary Type II hyperlipidemia. - patient is currently taking a lipid modifying medication other than Zocor 40mg & is willing to discontinue this medication for the duration of the study; or the patient is not taking any lipid modifying medication. - At Screening, depending upon the patient’s group classification, the patient must meet the Lipid Entry Criteria. - Patient is willing to withdraw from all prohibited medications. - Patient is compliant with the NCEP TLC diet for a minimum of 6 weeks prior to Qualification Visits & is willing to comply for the duration of the study. - Patients qualified for study enrollment must meet all of the following lab criteria: At Screening &/or Qualification: *Mean TG < 500mg/dL *CPK 3 x ULN *ALT & AST 1.3 x ULN At Qualification: *LDL-C Variability 15%. The LDL-C values of two consecutive blood samples drawn at Qualification 1 & Qualification 2, taken 1 week apart, must be within 15% of each other. *Based on the average LDL C & non-HDL C values at Qualification Visits 1 & 2, LDL C &/or non-HDL C does not satisfy NCEP ATP III treatment goals. - Patient has demonstrated 80% compliance with Zocor during Run-In Phase or did not require Run-In Phase. Exclusion Criteria: In order to participate, all the following criteria must be answered “No”: - Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives. - Patient consumes >14 alcoholic drinks per week or has a history of substance abuse or dependency within 12 months prior to Screening. - Patient has untreated or unsuccessfully treated psychiatric disease. - Patient has used an investigational study medication or participated in an investigational study within 30 days prior to the Screening Phase. - Patient has taken a prohibited medication within 6 weeks prior to the Qualification Visit 1. - Patient has a history of any of the following: a)active gallbladder disease within the preceding 12 months (cholecystectomy is allowed); b)pancreatitis; c)liver disease; d)persistent treated or untreated severe hypertension; e)arterial bleeding; f)unstable angina; g)myocardial infarction within the preceding 6 months; h)coronary artery bypass graft surgery within the preceding 6 months; i)angioplasty within the preceding 6 months; j)stroke, transient ischemic attack, or deep vein thrombosis within the preceding 6 months; k)congestive heart failure NYHA class III or IV; l)Type I diabetes, or uncontrolled Type II diabetes; m)active cancer or a diagnosis of cancer within the last 5 years; &/or n)Fibromyalgia, myopathy, rhabdomyolysis, unexplained muscle pain &/or discontinuation of statin due to myalgia. - Patient has any of the following abnormalities at any of the Screening &/or Qualification Visits: a)CPK elevation > 3 x ULN; b)AST or ALT > 1.3 times ULN; c)creatinine clearance < 30mL/min; d)HbA1c >8%; e)active gout symptoms &/or uric acid level >1.3 x ULN; f)active peptic ulcer disease; g)active hepatitis, active liver disease; &/or h)life expectancy <2 years. - Patient has any health condition or lab abnormality that, in the opinion of the Principal Investigator, may be adversely affected by the procedures or medications in this study. - At Screening, patient is receiving Zocor >40mg daily.
Total Enrollment: 1000
Location and Contact Information:
Health Core *Recruiting*
Newark, Delaware, 19713-2094
United States
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Atlanta Diabetes Associates *Recruiting*
Atlanta, Georgia, 30309
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Heartland Research Associates, LLC *Recruiting*
Wichita, Kansas, 67207
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MD Medical Research *Recruiting*
Oxon Hill, Maryland, 20745
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Saint Lukes Health System *Recruiting*
Kansas, Missouri, 64111
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Family Practice Medical Associates *Recruiting*
Mt. Laurel, New Jersey, 08054
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Recruiting Frank Pettinelli
Osvaldo Brusco, MD *Recruiting*
Corpus Christi, Texas, 78404
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Recruiting Osvaldo Brusco
Heartcare Midwest *Not yet recruiting*
Peoria, Illinois, 61614
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LDL-Aphresis Center KU Medical Center *Not yet recruiting*
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Dept. of Med Research at CNY Family Care *Recruiting*
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Mid-Ohio Heart Clinic Inc. *Not yet recruiting*
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Cleveland Clinic Foundation *Not yet recruiting*
Cleveland, Ohio, 44195
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Cardiology Consultants of Philadelphia *Not yet recruiting*
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Prime Care Medical Center *Recruiting*
Selmer, Tennessee, 38375
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Sacramento Heart & Vascular Research Center *Not yet recruiting*
Sacramento, California, 95825
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Desert Cardiology Center *Not yet recruiting*
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Jacksonville Heart Center *Recruiting*
Jacksonville, Florida, 32207
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Broward General Medical Center Cardiovascular Center *Not yet recruiting*
Ft. Lauderdale, Florida, 33316
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Dr. Ruotsi and Dr. Bertolino *Recruiting*
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Tiena Health Research; University of Texas *Not yet recruiting*
Irving, Texas, 75039
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Marshall University School of Medicine, Univeristy Physicians Internal Medicine *Not yet recruiting*
Huntington, West Virginia, 25701
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Maricopa Medical Center Dept. of Internal Medicine *Recruiting*
Mesa, Arizona, 85206
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Recruiting William Dachman
SoLUtions, St. Louis University *Recruiting*
St. Louis, Missouri, 63104
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Recruiting Denise Janosik
University of Washington *Not yet recruiting*
Seattle, Washington, 98104
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Not yet recruiting Robert Knopp
Ark City Clinic *Recruiting*
Arkansas City, Kansas, 67005
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Recruiting Harrel Proctor
Sterling Research Group, LTD *Not yet recruiting*
Erlanger, Kentucky, 41018
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Not yet recruiting Raymond Timmerman
Cardiology Consultants of Philadelphia *Recruiting*
Upland, Pennsylvania, 19013
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Recruiting Ancil Jones
Northside Internal Medicine *Recruiting*
Spokane, Washington, 99208
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Recruiting Timothy Gardner
CANC Health Education and Research Institute *Not yet recruiting*
Charleston, West Virginia, 25304
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Not yet recruiting Robert Touchon
East Bay Clinical Trial Center *Recruiting*
Concord, California, 94520
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Recruiting Roy Kaplan
Progressive Clinical Research *Recruiting*
Vista, California, 92083
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Recruiting John LaFata
University of Maryland, School of Medicine *Not yet recruiting*
Baltimore, Maryland, 21201
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Not yet recruiting Michael Miller
Heart and Lung Center *Not yet recruiting*
Newark, Ohio, 43055
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Not yet recruiting Hans Wee
Mima Century Research Associates *Not yet recruiting*
Melbourne, Florida, 32901
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Not yet recruiting Ralph Vicari
Atlanta VA Medical Center *Not yet recruiting*
Decatur, Georgia, 30033
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Axtell Clinic *Recruiting*
Newton, Kansas, 67114
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Recruiting Richard Glover
Boston Clinic Trials *Recruiting*
Brighton, Massachusetts, 02135
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Recruiting Robert Bargar
Hunter Holmes McGuire VAMC *Not yet recruiting*
Richmond, Virginia, 23249
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Anchor Research Center *Not yet recruiting*
Naples, Florida, 34102
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Coastal Cardiology, PA *Not yet recruiting*
Charleston, South Carolina, 29403
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South Central Wisconsin Heart *Not yet recruiting*
Madison, Wisconsin, 53715
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Cedars-Sinai Medical Center *Not yet recruiting*
Los Angeles, California, 90048
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Division of Cardiovascular Medicine, L-543 Kentucky Clinic *Not yet recruiting*
Lexington, Kentucky, 40536-0284
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Mercy Health Research *Recruiting*
Chesterfield, Missouri, 63017
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Sanger Clinic / Carolinas Medical Center *Not yet recruiting*
Charlotte, North Carolina, 28204
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Not yet recruiting Geoffrey Rose
IHC, Endocrinology, Diabetes and Podiatry *Recruiting*
Ogden, Utah, 84403
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Recruiting Jack Wahlen
Piedmont Primary Care *Not yet recruiting*
Warrenton, Virginia, 20186
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Not yet recruiting Steven Elten
Wisconsin Heart *Recruiting*
Madison, Wisconsin, 53715
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Recruiting David Ende
Global Clin-Reg Solutions, Inc *Not yet recruiting*
San Jose, California, 95120
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Scripps Clinic *Not yet recruiting*
La Jolla, California, 92037
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Not yet recruiting Ermina Guarneri
Cardiovascular Research Center of South Florida *Not yet recruiting*
Miami, Florida, 33173
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Not yet recruiting Ramon Lloret
Prime Care Research *Not yet recruiting*
Miami, Florida, 33176
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Not yet recruiting Mark Kutner
Metabolic Research Institute, Inc *Recruiting*
West Palm Beach, Florida, 33401
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Recruiting William Kaye
Cardiovascular Research of Forsyth Medical Center *Not yet recruiting*
Winston Salem, North Carolina, 27103
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Primary Care, Inc *Not yet recruiting*
Smithfield, Rhode Island, 02896
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Miami Research Associates *Recruiting*
Miami, Florida, 33143
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Recruiting Diane Krieger
Parkview Research Center *Not yet recruiting*
Ft. Wayne, Indiana, 46805
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Not yet recruiting Eric White
Tufts-New England Medical Center *Not yet recruiting*
Boston, Massachusetts, 02111
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The Methodist Hospital *Not yet recruiting*
Houston, Texas, 77030
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Grady Health System Lipid Clinic and CV Risk Reduction Program *Not yet recruiting*
Athens, Georgia, 30303
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Heartland Research Associates, LLC *Recruiting*
Wichita, Kansas, 67212
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Recruiting Timothy Koehler
Jackson Clinic *Recruiting*
Jackson, Tennessee, 38305
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Recruiting James Payne
'nTouch Research *Recruiting*
Dallas, Texas, 75230
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Recruiting Patricia Chandler
Daniel W. Gottlieb, MD, VS *Recruiting*
Burien, Washington, 98166
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Recruiting Daniel Gottlieb
HealthMark, LLC, University of Colorado *Not yet recruiting*
Denver, Colorado, 80222
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Not yet recruiting Wayne Peters
Miami Heart Research Insitute *Not yet recruiting*
Miami, Florida, 33140
United States
Not yet recruiting Maria Canossa-Terris
Sterling Research Group, Ltd. *Not yet recruiting*
Cincinnati, Ohio, 45219
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Not yet recruiting Eli Roth
Ohio University of College of Osteopathic Medicine *Not yet recruiting*
Athens, Ohio, 45701
United States
Not yet recruiting Frank Schwartz
San Diego VA Medical Center *Not yet recruiting*
San Diego, California, 92161
United States
Not yet recruiting Matt Ito
Cardiology Associates of New Haven PC *Not yet recruiting*
Guilford, Connecticut, 06437
United States
Not yet recruiting Jamie Gerber
Flamingo Clinical Research Inc. *Recruiting*
Cooper City, Florida, 33330
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Recruiting Aleyda Borge
University Clinical Research, Inc *Recruiting*
Pembroke Pines, Florida, 33024
United States
Recruiting Larry Gilderman
John Hopkins University- Lipid Clinic *Not yet recruiting*
Baltimore, Maryland, 21205
United States
Not yet recruiting Peter Kwiterovich
Cardiology Consultants of Philadelphia *Not yet recruiting*
Philadelphia, Pennsylvania, 19148
United States
Not yet recruiting Dean Karalis
Long Beach VA Medical Center *Not yet recruiting*
Long Beach, California, 90822
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Not yet recruiting Moti Kashyap
Cardiac Specialists *Recruiting*
Fairfield, Connecticut, 06827
United States
Recruiting Adam Schusseim
Heartland Research Associates, LLC *Not yet recruiting*
Wichita, Kansas, 67207
United States
Not yet recruiting Timothy Koehler
University of New Mexico *Not yet recruiting*
Albuquerque, New Mexico, 87131
United States
Not yet recruiting Kathleen Colleran
Duke University Medical Center *Not yet recruiting*
Durham, North Carolina, 27710
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Not yet recruiting John Guyton
Medical Arts Clinic *Not yet recruiting*
Corsicana, Texas, 75110
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Not yet recruiting John Updegrove
Lovelace Scientific Resources, Inc. *Recruiting*
Phoenix, Arizona, 85016
United States
Recruiting Richard Albery
ThinkTank Clinical Research, LLC *Not yet recruiting*
Carlsbad, California, 92008
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Not yet recruiting Maurice Buchbinder
Phoenix Internal Medical Association *Recruiting*
Waterbury, Connecticut, 06708
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Recruiting Leonardi Koliani
Cardio Vascular Associates, PSC Springs Medical Center *Recruiting*
Louisville, Kentucky, 40205
United States
Recruiting Joseph Lash
Washington University Medical School *Not yet recruiting*
St. Louis, Missouri, 63110
United States
Not yet recruiting Anne Goldberg
Radiant Research *Not yet recruiting*
Lawrenceville, New Jersey, 08648
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Not yet recruiting Neerja Misra
Schuster Cardiology Associates, Inc *Not yet recruiting*
Kettering, Ohio, 45429
United States
Not yet recruiting Franklin Handel
Additional Information:
Study ID Numbers: 019-02-03-CR; OCEANS
Study Start Date: March 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080275
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Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS)
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