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

This study has been completed.
Information provided by:
Kos Pharmaceuticals Identifier:
First received: March 25, 2004
Last updated: October 31, 2006
Last verified: October 2006

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
Hypercholesterolemia Drug: Niacin Extended-Release and simvastatin Tablets Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Kos Pharmaceuticals:

Estimated Enrollment: 600
Study Start Date: March 2004
Detailed Description:


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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00080275     History of Changes
Other Study ID Numbers: 019-02-03-CR
Study First Received: March 25, 2004
Last Updated: October 31, 2006

Keywords provided by Kos Pharmaceuticals:
Coronary Heart Disease
High-Density Lipoprotein Cholesterol
Low-Density Lipoprotein Cholesterol
Niacin ER/simvastatin
Total Cholesterol

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on September 21, 2017