OPEN LABEL TRIAL OF NICOSTATIN (NIACIN /LOVASTATIN)
Wake Forest University, Winston Salem NC
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Abstract
Following succesful completion of the ongoing protocol"Evaluation of the Safety and Efficacy of Nicostatin (a Combination Tablet of Niacin Extended-Release/Lovastatin immediate-release): A Dose-Response Study" (SPID 0161), subjects will be asked to participate in the extension study. The purpose of the extension study is to further evaluate the safety and effectiveness of Nicostatin in patients with high cholesterol levels (fat in blood). Nicostatin is a drug, which in combination of two cholesterol lowering medications, an extended-release niacin (the same kind that is found in Niaspan, a drug which is approved by the FDA) and lovastatin, a "statin" (the same medicine found in Mevacor, a drug also approved by the FDA). Nicostatin is not yet approved by the FDA.
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