SEACOAST: The Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study   Sponsor     Kos Pharmaceuticals, Inc.   Berman Center Site Principal Investigator     Richard H. Grimm, MD, MPH, PhD   Berman Center Site Coordinator     Sandra Graham, RN 612-341-7923   Description     Niacin and simvastatin are medications that both have been approved to treat high cholesterol. The purpose of this study is to compare the effectiveness and safety of a combination of niacin (extended release) and simvastatin (immediate release), called NS, at different doses. Study participation lasts 26-44 weeks and involves 6-10 clinic visits.   Role of the Berman Center     The Berman Center will recruit, qualify, and enroll 12 study participants between March 2004 and February 2005, and will conduct all 6-10 study visits for each participant.   Basic enrollment information     Men and women, 18 years of age or older, with Type II hyperlipidemia, with mean triglycerides < 500 mg/dL may be eligible to participate in this trial. Participants must be willing to stop taking their cholesterol-lowering medication during the study period.   Abstract     Researchers estimate that only 10 to 54% of patients receiving lipid-altering therapy meet goals recommended by the National Cholesterol Education Program (NCEP). Combination therapy is appropriate in patients who do not meet their LDL-C and/or non-HDL-C goals on monotherapy. Recommended combination therapy includes the addition of niacin to a statin. The purpose of this study is to evaluate the safety and efficacy of second-line therapy with Niacin ER and Simvastatin IR (NS) relative to monotherapy with Zocor in patients who do not satisfy NCEP ATP III lipid goals. This is a Phase III, 20 week, randomized, double-blind, multi-center, dose-escalation study with a 1 to 10 week Run-In Phase depending on compliance to diet and meeting specific Lipid Qualification criteria. The study is designed to evaluate the safety and efficacy of NS in patients with Type II hyperlipidemia with LDL-C and/or non-HDL-C levels that warrant treatment based upon the NCEP ATP III Expert Panel Guidelines.1 The study is comprised of a Screening Phase to determine enrollment eligibility, a Run-In Phase (open-label) to attempt to meet NCEP ATP III goals on Zocor monotherapy, Lipid Qualification to determine randomization eligibility, Randomization, and a Treatment Phase (double-blind). Approximately 525 patients will be randomized into seven treatment arms, each comprised of approximately 75 patients. Approximately 50 study sites will participate.