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

Hypercholesterolemia Clinical Trial

Official title:

An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080275
• Other study ID #: 019-02-03-CR
• Secondary ID: OCEANS
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2004
• Last updated: October 31, 2006
• Start date: March 2004

Study information

• Verified date: October 2006
• Source: Kos Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia

Intervention

Drug:
• Niacin Extended-Release and simvastatin Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kos Pharmaceuticals