Endpoint Validation Study (0524A-015)

Merck Sharp & Dohme LLC165 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

165

Conditions

Flushing

Interventions

MK0524A, /Duration of Treatment : 8 WeeksDRUG

Comparator : placebo (unspecified) /Duration of Treatment : 8 WeeksDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.