Evaluation of the Safety & Efficacy of a Combination of N... | NCT00080275

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

NCT00080275

Sponsor

Kos Pharmaceuticals

Status

Completed

Last Update Posted

Nov 1, 2006Estimated

Enrollment

600

Phase

Phase 3

Conditions

Hypercholesterolemia

Interventions

Niacin Extended-Release and simvastatin Tablets

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
OCEANS

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 25, 2004

First Submission Date that Met QC Criteria

Mar 26, 2004

First Posted Date

Mar 29, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2006

Last Update Posted Date

Nov 1, 2006Estimated

Description Module

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.

Conditions Module

Conditions

Hypercholesterolemia

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600

Name	Type	Description	Arm Group Labels	Other Names
Niacin Extended-Release and simvastatin Tablets	Drug

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18422390	Derived	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.

ID	Term
D006937	Hypercholesterolemia
D003327	Coronary Disease
D050171	Dyslipidemias
D050197	Atherosclerosis
D020521	Stroke

ID	Term
D006949	Hyperlipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic