MK0524A Phase IIb Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 26, 2007

Last Updated Date

September 26, 2007

Start Date ^†

June 2004

Current Primary Outcome Measures ^†

To determine the effect of MK0524A on lipids and blood glucose [ Time Frame: 17 Weeks ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

To establish the dose for limiting flushing symptoms induced by NIASPAN (R) [ Time Frame: 17 Weeks ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

MK0524A Phase IIb Study

Official Title ^†

Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Condition ^†

Flushing

Intervention ^†

Drug: Comparator: niacin / Duration of Treatment: 17 Weeks
Drug: MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks
Drug: Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

450

Completion Date

June 2004

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00536237

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.