Flushing
Conditions
Brief summary
The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.
Interventions
DRUGMK0524A, /Duration of Treatment : 4 Weeks
DRUGComparator : niacin /Duration of Treatment : 1 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
* Patient is male or female between 18 and 70 years of age * Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study
Exclusion criteria
* Patient has a history of hypersensitivity to niacin or niacin-containing products * Patient is currently experiencing menopausal hot flashes * Patient consumes more than 2 alcoholic beverages per day * Patient has poorly controlled Type 1 or Type 2 diabetes mellitus * Patient engages in vigorous exercise or an aggressive diet regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme. | Over 1 week |
Secondary
| Measure | Time frame |
|---|---|
| MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater). | Daily |
Outcome results
None listed