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

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

Genetics Home Reference related topics:

hypercholesterolemia

MedlinePlus related topics:

Cholesterol

Drug Information available for:

Sodium chloride Simvastatin Cholest-5-en-3-ol (3beta)- Niacin Niacin hydrochloride Lipids

U.S. FDA Resources

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)

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

Study ID Numbers:	019-02-03-CR, OCEANS
First Received:	March 25, 2004
Last Updated:	October 31, 2006
ClinicalTrials.gov Identifier:	NCT00080275
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

Study placed in the following topic categories:

Atherosclerosis

Heart Diseases

Hyperlipidemias

Metabolic Diseases

Cerebral Infarction

Simvastatin

Stroke

Coronary Disease

Nicotinic Acids

Metabolic disorder

Hypercholesterolemia

Niacin

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Vasodilator Agents

Vitamin B Complex

Molecular Mechanisms of Pharmacological Action

Antilipemic Agents

Growth Substances

Physiological Effects of Drugs

Enzyme Inhibitors

Anticholesteremic Agents

Cardiovascular Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

Therapeutic Uses

Vitamins

Micronutrients

ClinicalTrials.gov processed this record on November 30, 2008

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