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

Condition(s) targeted: Hypercholesterolemia

Intervention: Niacin Extended-Release and simvastatin Tablets (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Kos Pharmaceuticals

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.

Official title: An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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

Starting date: March 2004
Last updated: October 31, 2006