NCT00533312

Brief Summary

A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
407

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2005

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
Last Updated

April 7, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

September 19, 2007

Last Update Submit

April 5, 2017

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.

    After 4 weeks

Secondary Outcomes (1)

  • To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.

    After 4 weeks

Interventions

Comparator : placebo (unspecified) / Duraton of Treatment: 4 WeeksDRUG
MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 WeeksDRUG
Comparator : niacin / Duraton of Treatment: 4 WeeksDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must be between the ages of 18 and 70 years
  • Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant

You may not qualify if:

  • Patient has a history of peptic ulcer or gout
  • Patient is sensitive to niacin or products containing niacin
  • Patient drinks more than 2 alcoholic drinks per day
  • Patient has certain heart disease, cancer, or is HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lai E, De Lepeleire I, Crumley TM, Liu F, Wenning LA, Michiels N, Vets E, O'Neill G, Wagner JA, Gottesdiener K. Suppression of niacin-induced vasodilation with an antagonist to prostaglandin D2 receptor subtype 1. Clin Pharmacol Ther. 2007 Jun;81(6):849-57. doi: 10.1038/sj.clpt.6100180. Epub 2007 Mar 28.

    PMID: 17392721RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

NiacinMK-0524Duration of Therapy

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 21, 2007

Study Start

April 1, 2005

Primary Completion

July 1, 2005

Study Completion

January 1, 2007

Last Updated

April 7, 2017

Record last verified: 2017-03