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Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

NCT00479388 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1216

Last updated 2015-03-10

Study results available
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Summary

This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.

Conditions

  • Primary Hypercholesterolemia
  • Mixed Dyslipidemia

Interventions

DRUG

Comparator: simvastatin

simvastatin (20mg to 40mg) for 12 weeks.

DRUG

niacin (+) laropiprant

One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.

DRUG

Comparator: atorvastatin calcium

atorvastatin calcium (20mg to 40mg) for 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-07-31
Completion
2008-10-31

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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 NCT00479388 on ClinicalTrials.gov