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Completed

NCT Number: NCT00533312

MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)

A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must be between the ages of 18 and 70 years
  • Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant

Exclusion criteria

  • Patient has a history of peptic ulcer or gout
  • Patient is sensitive to niacin or products containing niacin
  • Patient drinks more than 2 alcoholic drinks per day
  • Patient has certain heart disease, cancer, or is HIV positive

Treatment and study plan

Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks

Drug

MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks

Drug

Comparator : niacin / Duraton of Treatment: 4 Weeks

Drug

Primary outcomes

  1. To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.

    Time frame: After 4 weeks

Secondary outcomes

  1. To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.

    Time frame: After 4 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blinded, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of MK0524A Compared to NIASPAN (TM)

Important dates

Study start
2005
Primary completion
2005
Study completion
2007
First posted
Sep 21, 2007
Registry last updated
Apr 7, 2017

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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