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

Phase 3

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00082251
• Lead Sponsor: Kos Pharmaceuticals

Brief 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).

Detailed Description

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

Study Timeline

• Study First Submitted: 2004-05-03
• Study First Submitted QC: 2004-05-04
• Study First Posted: 2004-05-05
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-31
• Last Update Posted: 2006-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL