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Completed

NCT Number: NCT00479388

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

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.

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Key information

Conditions

Primary Hypercholesterolemia Mixed Dyslipidemia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia
  • Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria

Exclusion criteria

  • Patient whose LDL-C values are not within protocol specified range

Treatment and study plan

Comparator: simvastatin

Drug

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

Other names: Zocor®

niacin (+) laropiprant

Drug

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.

Other names: MK0524A

Comparator: atorvastatin calcium

Drug

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

Other names: atorvastatin

Primary outcomes

  1. Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12

    Time frame: Baseline and 12 Weeks

Secondary outcomes

  1. Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12

    Time frame: Baseline and 12 Weeks

  2. Percent Change From Baseline in Triglycerides at Week 12

    Time frame: Baseline and 12 Weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of Extended-release (ER) Niacin/Laropiprant in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 28, 2007
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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