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

Phase 3

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00080275
• Lead Sponsor: Kos Pharmaceuticals

Brief Summary

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.

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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2004-03-25
• Study First Submitted QC: 2004-03-26
• Study First Posted: 2004-03-29
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-31
• Last Update Posted: 2006-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL