Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
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|ClinicalTrials.gov Identifier: NCT00080275|
Recruitment Status : Completed
First Posted : March 29, 2004
Last Update Posted : November 1, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Drug: Niacin Extended-Release and simvastatin Tablets||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2004|