NCT00080275

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2004

Completed
Last Updated

November 1, 2006

Status Verified

October 1, 2006

First QC Date

March 25, 2004

Last Update Submit

October 31, 2006

Conditions

Hypercholesterolemia

Keywords

NiacinStatinZocorSimvastatinCoronary Heart DiseaseDyslipidemiaAtherosclerosisHypercholesterolemiaStrokeHigh-Density Lipoprotein CholesterolLow-Density Lipoprotein CholesterolLipoproteinLipidNiacin ER/simvastatinTotal CholesterolTriglycerides

Interventions

Niacin Extended-Release and simvastatin TabletsDRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives.
  • HbA1c ≥ 9% in diabetic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18422390DERIVED

MeSH Terms

Conditions

HypercholesterolemiaCoronary DiseaseDyslipidemiasAtherosclerosisStroke

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 25, 2004

First Posted

March 29, 2004

Study Start

March 1, 2004

Last Updated

November 1, 2006

Record last verified: 2006-10