NCT00536237

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

September 26, 2007

Last Update Submit

August 24, 2015

Conditions

Flushing

Outcome Measures

Primary Outcomes (1)

  • To determine the effect of MK0524A on lipids and blood glucose

    17 Weeks

Secondary Outcomes (1)

  • To establish the dose for limiting flushing symptoms induced by NIASPAN (R)

    17 Weeks

Interventions

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Paolini JF, Mitchel YB, Reyes R, Kher U, Lai E, Watson DJ, Norquist JM, Meehan AG, Bays HE, Davidson M, Ballantyne CM. Effects of laropiprant on nicotinic acid-induced flushing in patients with dyslipidemia. Am J Cardiol. 2008 Mar 1;101(5):625-30. doi: 10.1016/j.amjcard.2007.10.023. Epub 2007 Dec 21.

    PMID: 18308010BACKGROUND

MeSH Terms

Conditions

Flushing

Interventions

Duration of TherapyNiacinMK-0524

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 27, 2007

Study Start

August 1, 2004

Primary Completion

February 1, 2005

Study Completion

December 1, 2006

Last Updated

August 25, 2015

Record last verified: 2015-08