NCT00533676CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 165
- Primary Endpoint
- To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
Time Frame: 8 weeks
Secondary Outcomes
- To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.(8 weeks)
Investigators
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