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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00080275
• Date of registration: 25/03/2004
• Primary sponsor: Kos Pharmaceuticals
• Public title: Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
• Scientific title: An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)
• Date of first enrolment: March 2004
• Target sample size: 600
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00080275
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypercholesterolemia

Intervention(s)

Drug: Niacin Extended-Release and simvastatin Tablets

Secondary ID(s)

019-02-03-CR

OCEANS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors