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Completed

NCT Number: NCT00376584

Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)

This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.

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Key information

Conditions

Hypercholesteremia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hypercholesterolemia Hyperlipidemia Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–70 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

  • Patient is appropriate candidate for niacin therapy
  • Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C <130 mg/dL at V1
  • Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C <130 mg/dL at V1
  • Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C <160 mg/dL at V1
  • Patient has TG <500 mg/dL (5.65 mmol/L) at V1
  • A patients historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria
  • ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA

Exclusion criteria

  • Patients with unstable doses of medications
  • Pregnant or lactating women, or women intending to become pregnant are excluded
  • Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed
  • Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)

Treatment and study plan

MK-0524A

Drug

ER Niacin

Drug

Placebo

Drug

Primary outcomes

  1. Global Flushing Severity Score (GFSS) during 7 days of treatment

    Time frame: during 7 days of treatment

Secondary outcomes

  1. Percentage of Participants Who Experience at Least 1 Adverse Event

    Time frame: up to 10 weeks

  2. Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event

    Time frame: up to 10 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2006
Registry last updated
Feb 16, 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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