Status:
COMPLETED
Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
Lead Sponsor:
Kos Pharmaceuticals
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
21+ years
Phase:
PHASE3
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 le...
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 bet...
Eligibility Criteria
Inclusion
- 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
- Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives.
- HbA1c ≥ 9% in diabetic patients
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00080275
Start Date
March 1 2004
Last Update
November 1 2006
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