Status:
COMPLETED
Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST
Lead Sponsor:
Kos Pharmaceuticals
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
The purpose of this 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).
Detailed Description
The purpose of this study is to compare the efficacy and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).
Eligibility Criteria
Inclusion
- Patient has primary Type II hyperlipidemia or mixed dyslipidemia
- If the patient is currently taking anti-dyslipidemic medications other than Zocor, he/she is willing to withdraw from these medications
- Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.
- LDL-C levels and/or Non HDL-C levels above normal for patients
- This study will be conducted both in the USA and internationally.
Exclusion
- Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives
- HbA1c ≥ 9% in diabetic patients
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00082251
Last Update
November 1 2006
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