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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypercholesterolemia

Keywords

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Niacin Statin Zocor Simvastatin Coronary Heart Disease Dyslipidemia Atherosclerosis Hypercholesterolemia Stroke High-Density Lipoprotein Cholesterol Low-Density Lipoprotein Cholesterol Lipoprotein Lipid Niacin ER/simvastatin Total Cholesterol Triglycerides

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Niacin Extended-Release and simvastatin Tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Countries

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United States

References

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Karas RH, Kashyap ML, Knopp RH, Keller LH, Bajorunas DR, Davidson MH. Long-term safety and efficacy of a combination of niacin extended release and simvastatin in patients with dyslipidemia: the OCEANS study. Am J Cardiovasc Drugs. 2008;8(2):69-81. doi: 10.2165/00129784-200808020-00001.

Reference Type DERIVED

PMID: 18422390 (View on PubMed)

Other Identifiers

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OCEANS

Identifier Type: -

Identifier Source: secondary_id

019-02-03-CR