ClinicalTrials.gg
CompletedNCT00533676Updated Feb 17, 2017

Endpoint Validation Study (0524A-015)

A Phase 2 interventional study of MK0524A, /Duration of Treatment : 8 Weeks and Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks in Flushing, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-02-17.

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

Phase
Phase 2
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).

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 165 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

  • Patients must be male or female between 18 to 70 years
  • Qualified women must be sterile (through surgery) and/or , and/or agree to use

Exclusion criteria

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
Terms in these criteria, in plain language(2)

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
165 participants

Interventions

  • DrugMK0524A, /Duration of Treatment : 8 Weeks
  • DrugComparator : placebo (unspecified) /Duration of Treatment : 8 Weeks
06

What researchers measure

Primary outcomes

  1. 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

  1. To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Norquist JM, Watson DJ, Yu Q, Paolini JF, McQuarrie K, Santanello NC. Validation of a questionnaire to assess niacin-induced cutaneous flushing. Curr Med Res Opin. 2007 Jul;23(7):1549-60. doi: 10.1185/030079907x199637. PubMed 17559750 ↗
  • Paolini JF, Mitchel YB, Reyes R, Thompson-Bell S, Yu Q, Lai E, Watson DJ, Norquist JM, Sisk CM, Bays HE. Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial. Int J Clin Pract. 2008 Jun;62(6):896-904. doi: 10.1111/j.1742-1241.2008.01739.x. Epub 2008 Apr 10. PubMed 18410350 ↗
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 Dec 2006 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 19, 2007
First posted
Sep 21, 2007
Start
Aug 2004
Primary completionActual
Dec 2006
CompletionActual
Dec 2006
Last update
Feb 17, 2017
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 Feb 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00533676
Responsible party
Sponsor
First posted
Sep 21, 2007
Start date
Aug 2004
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Feb 17, 2017

Study contacts

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

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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