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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kos Pharmaceuticals
• Treatments: Niacin; Niacinamide; Nicotinic Acids; Simvastatin

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