Conditions: Dyslipidemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1152
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms beyond 6 months and will measure the impact of withdrawal of laropiprant in patients following 20 weeks of stable maintenance therapy.

Detailed description:

Arms:
arm 1: One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg

tablets daily (2g/40 mg total) for 28 weeks arm 2: One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks. arm 3: One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.

Interventions: intervention 1: ER niacin (+) laropiprant (ERN/LRPT) intervention 2: ER niacin (+) laropiprant (ERN/LRPT) intervention 3: Extended-release niacin (ERN) intervention 4: Placebo to ERN/LRPT
Intervention descriptions: intervention 1: One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks intervention 2: One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks. intervention 3: Two 1g tablets ERN (2g total) once daily for 12 weeks. intervention 4: One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks

Protocol document: