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

This study has been completed.
Sponsor:
Information provided by:
Kos Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00080275
First received: March 25, 2004
Last updated: October 31, 2006
Last verified: October 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00080275     History of Changes
Other Study ID Numbers: 019-02-03-CR, OCEANS
Study First Received: March 25, 2004
Last Updated: October 31, 2006
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:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Simvastatin
Nicotinic Acids
Niacinamide
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014