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

Kos Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Hypercholesterolemia

Treatments

Drug: Niacin extended release and simvastatin tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00082251

019-01-03-CR

SEACOAST

Details and patient eligibility

About

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).

Full 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).

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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