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Completed

NCT Number: NCT00536237

MK0524A Phase IIb Study (0524A-011)(COMPLETED)

Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone.

Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.

Completed

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Key information

Conditions

Flushing Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

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

  • Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking > 50mg at screening
  • Must be willing to complete electronic diary

Exclusion criteria

  • Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT)
  • You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive
  • You consume more than 14 alcoholic drinks per week or more than 2 drinks per day

Treatment and study plan

Comparator: niacin / Duration of Treatment: 17 Weeks

Drug

MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks

Drug

Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks

Drug

Primary outcomes

  1. To determine the effect of MK0524A on lipids and blood glucose

    Time frame: 17 Weeks

Secondary outcomes

  1. To establish the dose for limiting flushing symptoms induced by NIASPAN (R)

    Time frame: 17 Weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Sep 27, 2007
Registry last updated
Aug 25, 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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