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Sponsored by: |
Kos Pharmaceuticals |
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Information provided by: | Kos Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00082251 |
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).
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolemia |
Drug: Niacin extended release and simvastatin tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
This study will be conducted both in the USA and internationally.
Exclusion Criteria:
Study ID Numbers: | 019-01-03-CR, SEACOAST |
Study First Received: | May 3, 2004 |
Last Updated: | October 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00082251 |
Health Authority: | United States: Food and Drug Administration |
Dyslipidemia High Blood Cholesterol Coronary Heart Disease Hypertension National Cholesterol Education Program Adult Treatment Panel III Niacin Simvastatin Diabetes Peripheral Vascular Disease |
Cerebrovascular disease Stroke High-Density Lipoprotein Cholesterol Hydroxymethyl Glutaryl Coenzyme A High-Sensitivity C-Reactive Protein Low-Density Lipoprotein Cholesterol Lipoprotein (a) Lipoprotein A-I Total Cholesterol Triglycerides |
Metabolic Diseases Heart Diseases Peripheral Vascular Diseases Hyperlipidemias Cerebral Infarction Simvastatin Stroke Vascular Diseases Diabetes Mellitus Cerebrovascular Disorders |
Coronary Disease Nicotinic Acids Metabolic disorder Niacin Hypercholesterolemia Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders Hypertension |
Antimetabolites Vasodilator Agents Vitamin B Complex Molecular Mechanisms of Pharmacological Action Antilipemic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Vitamins Micronutrients |