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 · Phase 2, Interventional, and Treatment

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

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.

Conditions studied

Flushing

Browse trials for

Flushing 60

Who can participate

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

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 HIV positive
You consume more than 14 alcoholic drinks per week or more than 2 drinks per day

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

What researchers measure

Primary outcomes

To determine the effect of MK0524A on lipids and blood glucose
Time frame: 17 Weeks

Secondary outcomes

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

Study locations

No study locations are listed for this record.

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 ↗

Registry details

Key details

Study ID: NCT00536237
Lead sponsor: Merck Sharp & Dohme LLC
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 ↗

Not currently enrolling

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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