Flushing
Conditions
Brief summary
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.
Interventions
DRUGComparator: niacin / Duration of Treatment: 17 Weeks
DRUGMK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks
DRUGComparator: placebo (unspecified) / Duration of Treatment: 17 Weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of MK0524A on lipids and blood glucose | 17 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| To establish the dose for limiting flushing symptoms induced by NIASPAN (R) | 17 Weeks |
Outcome results
None listed