ClinicalTrials.gg
CompletedNCT00536237Updated Aug 25, 2015

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

A Phase 2 interventional study of Comparator: niacin / Duration of Treatment: 17 Weeks and MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks in Flushing, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-08-25.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Flushing

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03

In context

Flushing

22 studies on the registry are indexed under Flushing; 5 are open to participants now.

This study's enrollment of 154 is above the median of 90 across 19 interventional studies indexed under Flushing.

Browse Flushing studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.

Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 positive
  • You consume more than 14 alcoholic drinks per week or more than 2 drinks per day
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
154 participants (actual)

Interventions

  • DrugComparator: niacin / Duration of Treatment: 17 Weeks
  • DrugMK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks
  • DrugComparator: placebo (unspecified) / Duration of Treatment: 17 Weeks
06

What researchers measure

Primary outcomes

  1. To determine the effect of MK0524A on lipids and blood glucose

    Time frame: 17 Weeks

Secondary outcomes

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

    Time frame: 17 Weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 18308010 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2004, a primary completion of Feb 2005 and a completion of Dec 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2007
First posted
Sep 27, 2007
Start
Aug 2004
Primary completionActual
Feb 2005
CompletionActual
Dec 2006
Last update
Aug 25, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00536237
Responsible party
Sponsor
First posted
Sep 27, 2007
Start date
Aug 2004
Primary completion
Feb 2005
Completion
Dec 2006
Last update
Aug 25, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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