Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
Information source: Kos Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Niacin Extended-Release and simvastatin Tablets (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Kos Pharmaceuticals
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.
Clinical Details
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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.
Eligibility
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
Locations and Contacts
Additional Information
Starting date: March 2004
Last updated: October 31, 2006
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