Efficacy and Safety Study of Nidadd in the Management of Hyperlipidemia
To assess the efficacy and safety of Nidadd (extended-release niacin) in patients with hyperlipidemia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Placebo-Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Nidadd in the Management of Hyperlipidemia|
- Change from baseline in HDL-c levels
- Changes from baseline in serum total cholesterol , LDL-c, and triglycerides
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||August 2005|
This is a randomized, double-blind, placebo-controlled, and multicenter study. A total of at least 50 patients will be recruited to achieve 40 evaluable patients required to assess the safety and efficacy of escalating doses of extended-release Nidadd in hyperlipidemic patients.
- The trial begins with measurement of baseline lipid levels. Fasting blood samples will be collected at screening and each treatment visit (except visit 3) for lipid analysis and safety monitoring. Chemistry laboratory tests and hematological testing are performed periodically. Patient’s diet education will be given by dieticians or appropriately trained counselors at visit 1 and 2.
- Patients who are taking any lipid-modifying drugs will be required to go through a 4-week washout / diet-controlled period prior to randomization (visit 2).
- Treatment duration is 16 weeks in total: Patients randomized to treatment with Nidadd will receive 500 mg for the first 8 weeks of the medication period. For another 8 weeks, the dose is then increased to 1000 mg and is maintained to the end of the study. The patients in control group will take placebo in a same fashion as that of Nidadd group throughout entire 16 weeks.
- The primary measure of efficacy is the change from baseline in serum HDL-c level. Secondary measures of efficacy are changes from baseline in serum total cholesterol, LDL-c, and triglycerides.
- Safety and tolerability will be evaluated from adverse events, number of patients who prematurely discontinue the trial because of adverse events, and laboratory measures.
|Principal Investigator:||Jen-Der Lin, M.D.||Chang GungMemorial Hospital|
|Principal Investigator:||Jawl-Shan Huang, M.D.||Chang Gung Memorial Hospital|
|Principal Investigator:||Miaw-jene Liou, M.D.||Chang Gung Memorial Hospital|
|Principal Investigator:||Chih-ching Wang, M.D.||Chang Gung Memorial Hospital|
|Principal Investigator:||Yi-Jen Hung, M.D.||Tri-Service General Hospital|
|Principal Investigator:||Chang-Hsun Hsieh, M.D.||Tri-Service General Hospital|
|Principal Investigator:||Chih-Tsueng He, M.D.||Tri-Service General Hospital|
|Principal Investigator:||Huey-Herng Sheu, M.D.||Taichung Veterans General Hospital|
|Principal Investigator:||Yu-Ling Lin, M.D.||Taichung Veterans General Hospital|
|Principal Investigator:||Shih-Yi Lin, M.D.||Taichung Veterans General Hospital|
|Principal Investigator:||Yih-Jing Tang, M.D.||Taichung Veterans General Hospital|