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Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)

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ClinicalTrials.gov Identifier: NCT00080275
Recruitment Status : Completed
First Posted : March 29, 2004
Last Update Posted : November 1, 2006
Sponsor:
Information provided by:
Kos Pharmaceuticals

Brief Summary:

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 or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Niacin Extended-Release and simvastatin Tablets Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)
Study Start Date : March 2004






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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 a lipid modifying medication other than Zocor & he/she is willing to discontinue this medication
  • LDL-C levels and/or non HDL-C levels above normal.
  • Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.

Exclusion Criteria:

  • Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives.
  • HbA1c ≥ 9% in diabetic patients

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00080275     History of Changes
Other Study ID Numbers: 019-02-03-CR
OCEANS
First Posted: March 29, 2004    Key Record Dates
Last Update Posted: November 1, 2006
Last Verified: October 2006

Keywords provided by Kos Pharmaceuticals:
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

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Niacin
Niacinamide
Nicotinic Acids
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
Growth Substances
Physiological Effects of Drugs