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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR007122-09
Application #
6408711
Study Section
General Clinical Research Centers Committee (CLR)
Project Start
1992-09-30
Project End
2001-02-28
Budget Start
Budget End
Support Year
9
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Type
DUNS #
041418799
City
Winston-Salem
State
NC
Country
United States
Zip Code
27106
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