Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST
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ClinicalTrials.gov Identifier: NCT00082251 |
Recruitment Status :
Completed
First Posted : May 5, 2004
Last Update Posted : November 1, 2006
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Sponsor:
Kos Pharmaceuticals
Information provided by:
Kos Pharmaceuticals
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia | Drug: Niacin extended release and simvastatin tablets | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST |
Resource links provided by the National Library of Medicine

MedlinePlus related topics:
Cholesterol Medicines
Information from the National Library of Medicine

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
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
No Contacts or Locations Provided
Publications:
ClinicalTrials.gov Identifier: | NCT00082251 |
Other Study ID Numbers: |
019-01-03-CR SEACOAST |
First Posted: | May 5, 2004 Key Record Dates |
Last Update Posted: | November 1, 2006 |
Last Verified: | October 2006 |
Keywords provided by Kos Pharmaceuticals:
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 |
Additional relevant MeSH terms:
Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Niacin Simvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |