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

Kos Pharmaceuticals

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Hypercholesterolemia

Interventions

Niacin extended release and simvastatin tabletsDRUG

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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