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

Sponsored by:	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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: 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
Study 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
Coronary Artery Disease
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 January 16, 2009