Flushing
Conditions
Brief summary
To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).
Interventions
DRUGMK0524A, /Duration of Treatment : 8 Weeks
DRUGComparator : placebo (unspecified) /Duration of Treatment : 8 Weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients must be male or female between 18 to 70 years * Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control
Exclusion criteria
* You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes * You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day * You are sensitive to niacin * You have a history gout * You drink more than 2 glasses of alcohol per day and you are not willing to stop * You don't have access to a telephone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF). | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period. | 8 weeks |
Outcome results
None listed