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

This study has been completed.

Sponsor:

Information provided by:

Kos Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00080275

First received: March 25, 2004

Last updated: October 31, 2006

Last verified: October 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	March 25, 2004
Last Updated Date	October 31, 2006
Start Date ^ICMJE	March 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00080275 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
Official Title ^ICMJE	An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)
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 least 600 subjects with a similar medical condition will take part in this study.
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 between two Titration Schedules for NS.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hypercholesterolemia
Intervention ^ICMJE	Drug: Niacin Extended-Release and simvastatin Tablets
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	600
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT00080275
Other Study ID Numbers ^ICMJE	019-02-03-CR, OCEANS
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Kos Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Kos Pharmaceuticals
Verification Date	October 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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