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Sponsored by: |
Kos Pharmaceuticals |
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Information provided by: | Kos Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00080275 |
The purpose of this 24 week 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).
At least 600 subjects with a similar medical condition will take part in this study.
Condition | Intervention | Phase |
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Hypercholesterolemia |
Drug: Niacin Extended-Release and simvastatin Tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS) |
Estimated Enrollment: | 600 |
Study Start Date: | March 2004 |
Objectives:
To evaluate the safety and efficacy of the combination product niacin ER and simvastatin (NS) in patients with primary type II dyslipidemia and to descriptively compare flushing rates between two Titration Schedules for NS.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 019-02-03-CR, OCEANS |
Study First Received: | March 25, 2004 |
Last Updated: | October 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00080275 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Niacin Statin Zocor Simvastatin Coronary Heart Disease Dyslipidemia Atherosclerosis Hypercholesterolemia |
Stroke High-Density Lipoprotein Cholesterol Low-Density Lipoprotein Cholesterol Lipoprotein Lipid Niacin ER/simvastatin Total Cholesterol Triglycerides |
Atherosclerosis Antimetabolites Vasodilator Agents Niacinamide Cerebral Infarction Nicotinamide Nicotinic Acids Vitamins Micronutrients Nicotinic Acid Metabolic Disorder Hypercholesterolemia Dyslipidemias Metabolic Diseases Hyperlipidemias |
Heart Diseases Vitamin B Complex Simvastatin Antilipemic Agents Stroke Trace Elements Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Coronary Disease Vitamin B3 Niacin Coronary Artery Disease Lipid Metabolism Disorders |
Antimetabolites Vasodilator Agents Vitamin B Complex Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Growth Substances Antilipemic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Vitamins Therapeutic Uses Micronutrients Hypercholesterolemia Niacin Dyslipidemias Lipid Metabolism Disorders |