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Niacin Plus Statin to Prevent Vascular Events

NCT00120289 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3414

Last updated 2016-04-06

Study results available
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Summary

The purpose of this study is to determine whether raising "good cholesterol" with a drug based on the vitamin niacin, while lowering "bad cholesterol" with a statin drug, can prevent more heart disease than the statin alone.

Conditions

Interventions

DRUG

Extended release niacin

2,000 mg/day or 1,500 mg/day if higher dose not tolerated

DRUG

Simvastatin

Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Abbott

    collaborator INDUSTRY

  • Axio Research. LLC

    lead INDUSTRY

Principal Investigators

  • Ruth McBride · Axio Research Corporation

  • William E. Boden, MD · Samuel S. Stratton VA Medical Center

  • Jeffrey Probstfield, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120289 on ClinicalTrials.gov