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

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).

Completed

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Key information

Conditions

Hypercholesterolemia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Disease Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nervous System Diseases Nutritional and Metabolic Diseases Peripheral Vascular Diseases Stroke Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Niacin extended release and simvastatin tablets

Drug

Sponsors and collaborators

Lead sponsor

Kos Pharmaceuticals

Industry

Registry information

Important dates

First posted: May 5, 2004
Registry last updated: Nov 1, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed