Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kos Pharmaceuticals
• Treatments: Niacin; Niacinamide; Nicotinic Acids; Simvastatin

Criteria

Inclusion Criteria:

• Patient has primary Type II hyperlipidemia or mixed dyslipidemia

• If the patient is currently taking anti-dyslipidemic medications other than Zocor, he/she is willing to withdraw from these medications

• Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.

• LDL-C levels and/or Non HDL-C levels above normal for patients

This study will be conducted both in the USA and internationally.

Exclusion Criteria:

• Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives

• HbA1c ≥ 9% in diabetic patients