MK0524A Phase IIb Study (0524A-011)(COMPLETED)

Phase 2

Completed

• Conditions: Flushing

• Registration Number: NCT00536237
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-02
• Study Completion: 2006-12
• Study First Submitted: 2007-09-26
• Study First Submitted QC: 2007-09-26
• Study First Posted: 2007-09-27
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
To determine the effect of MK0524A on lipids and blood glucose	17 Weeks

Secondary Outcome Measures

Name	Time	Method
To establish the dose for limiting flushing symptoms induced by NIASPAN (R)	17 Weeks