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

This study has been completed.

First Received: March 25, 2004 Last Updated: October 31, 2006 History of Changes

Sponsor:	Kos Pharmaceuticals
Information provided by:	Kos Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00080275

Purpose

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 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)

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Niacin Simvastatin Niacinamide Niacin hydrochloride

U.S. FDA Resources

Further study details as provided by Kos Pharmaceuticals:

Estimated Enrollment:	600
Study Start Date:	March 2004

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

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

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:

Antimetabolites
Vasodilator Agents
Vitamin B Complex
Hyperlipidemias
Metabolic Diseases
Niacinamide
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
Nicotinic Acids
Vitamins
Therapeutic Uses
Micronutrients
Hypercholesterolemia
Niacin
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 22, 2009